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Docetaxel (75) Prednisolone (6 cycles)) Ver1

Description: Chemotherapy Protocol PROSTATE DOCETAXEL(75)-PREDNISOLONE (6 cycles) Regimen Prostate-Docetaxel (75)-Prednisolone (6 cycles) Indication First line treatment of prostate cancer in combination with androgen deprivation therapy for the treatment of hormone naive metastatic prostate cancer (this is an unlicensed indication). Performance status 0, 1, 2 Toxicity Drug Docetaxel Prednisolone Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, osteoporosis The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFTs, PSA and U&Es prior to each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Version 1 (June 2016) Page 1 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) Haematological Consider a blood transfusion or erythropoietins if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to cycle one the following criteria should be met; Criteria Neutrophils Platelets Eligible Level 1x109/L or greater 50x109/L or greater Dose modifications based on haematological parameters apply to docetaxel only. Neutrophils (x109/L) 1 or greater less than 1 on the day of treatment or less than 1 with fever/infection at any time or less than 0.5 for more than 7 days Platelets (x109/L) 50 or greater less than 50 Dose Modifications (docetaxel) 100% 1st Occurrence Delay until recovery to 1x109/L or greater and then give 60mg/m2 2nd Occurrence Delay until recovery to 1x109/L or greater then give 45mg/m2 Dose Modifications (docetaxel) 100% 1st Occurrence Delay until recovery to 50x109/L or greater then give 60mg/m2 2nd Occurrence Delay until recovery to 50x109/L or greater then give 45mg/m2 Hepatic Impairment Consider weekly scheduling if there is a mild or moderate hepatic impairment Drug Bilirubin (μmol/L) AST/ALT (units/L) Alk Phos Dose (units/L) (% of original dose) N/A greater than 1.5xULN and greater than 2.5xULN Docetaxel greater than ULN and/ or greater than 3.5xULN and greater than 6xULN Give 75% Not Recommended Renal Impairment Drug Docetaxel Creatinine Clearance (ml/min) N/A Dose (% of original dose) No dose adjustment needed Version 1 (June 2016) Page 2 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose should then be reduced to 60mg/m2 or discontinued as appropriate. The following recommendations apply to docetaxel only. The prednisolone should be continued if the docetaxel is delayed. It should be stopped if the docetaxel is stopped but may require a reducing schedule. Peripheral Neuropathy Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2 once the neuropathy has resolved to NCI-CTC grade 2 or below. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops consider stopping treatment. Lacrimation Excessive lacrimation is related to cumulative docetaxel doses and occurs after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 60mg/m2. Skin Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCI-CTC grade 4 cutaneous toxicity. Stomatitis A NCI-CTC grade 2 stomatitis should result in a delay in treatment until it has become NCICTC grade 1 or below. Treatment may then be re-started at the previous dose. For a NCICTC grade 3 stomatitis delay treatment until it has recovered to NCI-CTC grade 1 or below then reduce the dose to 60mg/m2. Treatment should be stopped in relation to a NCI-CTC grade 4 stomatitis. Version 1 (June 2016) Page 3 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) Regimen Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation) consider a starting dose of 60mg/m² with a view to increase to 75mg/m² if well tolerated. Not all patients will require prednisolone. Please check with the relevant consultant before prescribing if prednisolone is to be included. 21 day cycle for 6 cycles Drug Docetaxel Prednisolone Dose 75mg/m2 5mg twice a day Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 1-21 incl. Oral Dose Information Docetaxel will be banded as per the agreed bands. Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses Docetaxel doses of more than 200mg should be diluted in 500ml sodium chloride 0.9% (maximum concentration 0.74mg/ml) Prednisolone is available as 5mg, 25mg (uncoated) and 2.5mg and 5mg (enteric coated) tablets. A soluble formulation is available. Administration Information Docetaxel hypersensitivity reactions tend to occur with the first or second infusion. For minor symptoms such as flushing or localised rashes the infusion should not be interrupted. For severe reactions including profound hypotension, bronchospasm and generalised erythema discontinue the infusion immediately. Prednisolone should be taken with or after food. Extravasation Docetaxel - exfoliant Version 1 (June 2016) Page 4 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) Additional Therapy Premedication - dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel Antiemetics 15-30 minutes prior to chemotherapy - metoclopramide 10mg oral or intravenous As take home medication - metoclopramide 10mg oral three times a day for 3 days then as required Additional Information Docetaxel is not licensed to treat this indication and is therefore ‘off label’. In order to use medicines that are unlicensed, or used for an unlicensed indication, each provider organisation must assure itself that the internal governance arrangements have been completed before the medicine is prescribed. These arrangements may be through the Trust’s Drugs and Therapeutics committee (or similar) and NHS England may ask for assurance of this process. Coding (OPCS) Procurement – X71.1 Delivery – X72.3 References 1.NHS England. Clinical Commissioning Policy Statement: Docetaxel in combination with androgen deprivation therapy for the treatment of hormone naive metastatic prostate cancer. B15/PS/a. Version 1 (June 2016) Page 5 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) Cycles 1, 2, 3, 4, 5 REGIMEN SUMMARY Docetaxel (75)-Prednisolone (6 cycles) Day minus 1 1. Dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel (from TTO)* Day 1 2. Warning – Check if Prednisolone required 3. Dexamethasone from TTO (see above)* 4. Metoclopramide 10mg oral or intravenous 5. Docetaxel 75mg/m2 in 250ml sodium chloride 0.9% intravenous infusion over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication prior to treatment. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone premedication administer dexamethasone 20mg intravenous 15-30 minutes prior to chemotherapy Take Home Medicines 6. Prednisolone 5mg twice a day oral for 21 days Administration Instructions Take with or after food. The dose of this medicine may need to be reduced gradually before stopping treatment. 7. Dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel 8. Metoclopramide 10mg oral three times a day for 3 days then 10mg three times a day when required for nausea. Cycle 6 Day minus 1 9. Dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel (from TTO)* Day 1 10. Warning – Check if Prednisolone required 11. Dexamethasone from TTO (see above)* 12. Metoclopramide 10mg oral or intravenous 13. Docetaxel 75mg/m2 in 250ml sodium chloride 0.9% intravenous infusion over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication prior to treatment. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone premedication administer dexamethasone 20mg intravenous stat 15-30 minutes prior to chemotherapy Version 1 (June 2016) Page 6 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) Take Home Medicines 14. Prednisolone 5mg twice a day oral for 21 days Administration Instructions Take with or after food. The dose of this medicine may need to be reduced gradually before stopping treatment. 15. Metoclopramide 10mg oral three times a day for 3 days then 10mg three times a day when required for nausea. * In Aria Planner the dexamethasone TTO will appear on day 1 of treatment. This is the supply for the next cycle. Version 1 (June 2016) Page 7 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 June 2016 None Dr Debbie Wright Pharmacist Dr Simon Crabb Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1 (June 2016) Page 8 of 8 Prostate-Docetaxel(75)-Prednisolone (6 cycles)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Prostatecancer/Docetaxel-75-Prednisolone-6-cycles-Ver1.pdf

Cetuximab-Irinotecan (14 day)

Description: Chemotherapy Protocol COLORECTAL CANCER CETUXIMAB-IRINOTECAN (14 day) This regimen may require funding Regimen • Colorectal Cancer–Cetuximab-Irinotecan (14 day) Indication • Metastatic colorectal cancer that is positive for the wild type KRAS genotype and that has progressed after failure of oxaliplatin and irinotecan based therapy. • WHO performance status 0, 1 Toxicity Drug Cetuximab Irinotecan Adverse Effect Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation Acute cholinergic syndrome, diarrhoea (may be delayed) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • Prior to starting therapy confirm a positive wild type KRAS status • FBC, LFT’s and U&E’s prior to day one of treatment • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.3 (October 2020) Page 1 of 7 Colorectal – Cetuximab-Irinotecan (14 day) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing on day one of cycle one the following criteria must be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L and/or the platelets are less than 100x109/L then delay treatment for seven days If the counts recover at this time restart the irinotecan at 80% of the original dose. If a fourteen day delay is required to allow counts to recover or there are two separate delays of seven days during treatment consider reducing the dose of irinotecan to 50% of the original dose or stopping treatment. This is one of the few regimens where asymptomatic low nadir neutrophil counts are an indication for dose modification. Where this figure is less than 0.5x109/L or where there has been an episode of febrile neutropenia the subsequent irinotecan dose should be reduced to 80% of the original dose. There is little need to adjust the dose of cetuximab for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Drug Cetuximab Irinotecan Hepatic Renal Administer only when the Administer only where the serum transaminases are 5xULN or creatinine is 1.5xULN or below below and the bilirubin is 1.5xULN or below For the 350mg/m2 dose if the No adjustments are necessary bilirubin is 26 to 51umol/L although there is limited inclusive prescribe 200mg/m2. If information the bilirubin is above 51umol/L consider stopping therapy. Other Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reactions reduce the infusion rate by 50% (the total should not exceed 240 minutes). For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. Once the reaction has Version 1.3 (October 2020) Page 2 of 7 Colorectal – Cetuximab-Irinotecan (14 day) resolved to NCI-CTC grade 1 or below then resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acniform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of NCI-CTC grade 3 skin toxicity develops or a NCI-CTC grade 4 toxicity at any time. UV radiation may worsen skin reactions. Sun safety practices should be followed during and for up to two months after the end of treatment. Stop treatment if there is a confirmed pneumonitis. Irinotecan Irinotecan is associated with a number of toxic reactions. The next cycle of treatment should not be administered until all toxicities have resolved to 0 or 1 of the National Cancer Institute Common Toxicity Criteria scale (NCI-CTC) within fourteen days. Diarrhoea must have resolved completely. Where a NCI-CTC grade 2 to 4 nonhaematological event has occurred the irinotecan dose must be reduced to 200mg/m2 in the first instance. If a second episode occurs despite this dose reduction delay until the symptoms have resolved and re-start the irinotecan at 150mg/m2. Stop treatment for a third episode. Regimen 14 day cycle for 6 cycles Drug Cetuximab Irinotecan Dose 500mg/m2 250mg/m2 Days 1 1 Route Intravenous infusion over 120 minutes (see administration) Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Version 1.3 (October 2020) Page 3 of 7 Colorectal – Cetuximab-Irinotecan (14 day) Dose Information • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml) • Irinotecan will be dose banded in accordance with the national dose bands (20mg/ml) • The maximum daily dose of irinotecan is 700mg Administration Information Extravasation • Cetuximab – neutral • Irinotecan – irritant Other • Individuals should be monitored for hypersensitivity for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 10mg/min. The first infusion is given over 120 minutes. If this infusion rate is well tolerated subsequent infusions may be given over 60 minutes • Irinotecan may be administered over 30-90 minutes Additional Therapy • 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral or intravenous - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral • Antiemetics 15-30 minutes prior to chemotherapy on day one only - ondansetron 8mg oral or intravenous As take home medication - dexamethasone 4mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral • Subcutaneous atropine 250microgram immediately prior to irinotecan for the prevention of acute cholinergic syndrome. A further 250microgram subcutaneous dose may be given to relieve cholinergic symptoms if they Version 1.3 (October 2020) Page 4 of 7 Colorectal – Cetuximab-Irinotecan (14 day) develop. • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed • Oral loperamide 2mg every two hours once first liquid stool appears and continue until 12 hours after the last liquid stool. Do not use for longer than 48 hours (maximum daily dose is 16mg). Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea • Consider oral ciprofloxacin 500mg twice daily where diarrhoea continues for more than 24 hours. Review the patient before starting this treatment. Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea References 1. Cunningham D, Humblett Y, Sienna S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-335. 2. Wilke H et al. Cetuximab plus irinotecan in heavily pre-treated metastatic colorectal cancer progressing on irinotecan. The MABEL study. JCO 2008; 26 (33): 5335-5343. Version 1.3 (October 2020) Page 5 of 7 Colorectal – Cetuximab-Irinotecan (14 day) REGIMEN SUMMARY Cetuximab-Irinotecan (14 day) Day One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Ondansetron 8mg oral or intravenous 6. Cetuximab 500mg/m2 over 120 minutes intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and the irinotecan 7. Atropine 250microgram subcutaneous for the prevention of irinotecan associated cholinergic symptoms 8. Irinotecan 250mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 9. Atropine 250microgram subcutaneous when required for the treatment of irinotecan associated cholinergic symptoms Take Home Medicines 10. Dexamethasone 4mg twice a day for 3 days starting the day after chemotherapy oral 11. Metoclopramide 10mg three times a day when required for the relief of nausea oral Version 1.3 (October 2020) Page 6 of 7 Colorectal – Cetuximab-Irinotecan (14 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By Update of premedication due to shortage of IV ranitidine. 1.3 October 2020 IV ranitidine changed to H2 antagonist according to local formulary choice and availability Arum Shortland Pharmacist Dr Debbie Wright Pharmacist Coding removed Dose banding updated Header changed Toxicities removed Bolus removed from intravenous bolus in supportive treatments Irinotecan administration 1.2 changed to 90 minutes May 2014 Metoclopramide dose changed to 10mg Dr Debbie Wright Pharmacist Donna Kimber Pharmacy Technician Atropine added as a standard treatment before irinotecan Coding updated Dexamethasone TTO clarified Disclaimer added 1.1 June 2012 Delivery code changed to X72.1 Dr Debbie Wright Pharmacist Liz Harrison Pharmacist 1 March 2012 None Dr Debbie Wright Pharmacist Dr Tim Iveson Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.3 (October 2020) Page 7 of 7 Colorectal – Cetuximab-Irinotecan (14 day)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Cetuximab-Irinotecan14day.pdf

Bevacizumab-Capecitabine

Description: Chemotherapy Protocol COLORECTAL CANCER BEVACIZUMAB-CAPECITABINE This protocol may require funding Regimen • Colorectal Cancer– Bevacizumab-Capecitabine Indication • The first line treatment of advanced colorectal cancer in patients who are • WHO performance status 0, 1, 2 Toxicity Drug Bevacizumab Capecitabine Adverse Effect Haemorrhage, hypertension, proteinuria, impaired wound healing, gastrointestinal perforations, fistulae, arterial thrombosis Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, LFTs and U&Es prior to day one of treatment • Blood pressure and dipstick urinalysis for proteinuria prior to treatment with bevacizumab • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with capecitabine. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions. Dose Modifications The dose modifications listed are for haematological, liver and renal function and some drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.1 (Nov 2020) Page 1 of 8 Colorectal-Bevacizumab-Capecitabine Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. (See below for information on bevacizumab and transfusions). Prior to prescribing on day one of cycle one the following criteria must be met; Criteria Neutrophils Platelets Eligible Level Equal to or more than 1.5x109/L Equal to or more than 100x109/L Dose modifications for haematological toxicity apply to capecitabine only. Neutrophils (x109/L) 1.5 or greater less than 1.5 Platelets (x109/L) 75 or greater less than 75 Dose Modifications (capecitabine) 100% Delay until neutrophils recover to 1.5x109/L or greater. If recovery occurs within 7 days restart at 100% of the original dose. If recovery occurs within 7-14 days restart at 75% (100% where appropriate) of the original dose. If recovery takes greater than 21 days stop treatment. Dose Modifications (capecitabine) 100% Delay until platelets recover to 75x109/L or greater. If recovery occurs within 7 days restart at 100% of the original dose. If recovery occurs within 7-14 days restart at 75% (100% where appropriate) of the original dose. If recovery takes greater than 21 days stop treatment. There is little need to adjust the dose of bevacizumab for haematological toxicity. Version 1.1 (Nov 2020) Page 2 of 8 Colorectal-Bevacizumab-Capecitabine Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bevacizumab Bilirubin (μmol/L) n/a AST/ALT Dose (% of original dose) n/a No information available Capecitabine Renal Impairment Drug Bevacizumab greater than 3xULN If treatment related consider or greater than 2.5xULN delaying treatment. For mild/moderate hepatic dysfunction due to liver metastasis dose modification may not be necessary. Creatinine Clearance (ml/min) n/a Dose (% of original dose) No information available Capecitabine 51 or greater 30-50 less than 30 100% 75% Contra-indicated Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Bevacizumab Bevacizumab doses should be omitted and not reduced for adverse reactions. If more than two doses are missed due to adverse events treatment should be stopped. It should be noted that the half life of bevacizumab is approximately twenty days. Discontinuation of treatment in response to adverse effects is not expected to influence the short term clinical evolution of the event, symptomatic treatment is often necessary. Bevacizumab should be stopped if the individual develops; • Gastrointestinal perforation • Arterial thromboembolic events • NCI-CTC grade 3 and above haemorrhagic events (requiring a blood transfusion or a major non-elective intervention) • NCI-CTC grade 3 and above congestive heart failure or left ventricular function • NCI-CTC grade 4 fistula Version 1.1 (Nov 2020) Page 3 of 8 Colorectal-Bevacizumab-Capecitabine If a NCI-CTC symptomatic grade 4 venous thromboembolic event occurs bevacizumab should be stopped. However, if this is a pulmonary embolism bevacizumab may be restarted once a full recovery has been made and the individual is anti-coagulated with a subcutaneous low molecular weight heparin. An oral anticoagulant must not be used. Hypertension is a common consequence of bevacizumab therapy. For a NCI-CTC grade 1 hypertension no treatment is necessary. NCI-CTC grade 2 hypertension, consider antihypertensive therapy. For a NCI-CTC grade 3 and above hypertension that is persistent consider stopping treatment. Bevacizumab may be continued for a NCI-CTC grade 1 proteinuria or the first occurrence of a grade 2 proteinuria. For the second occurrence of a NCI-CTC grade 2 proteinuria or any NCI-CTC grade 3 proteinuria give the bevacizumab as scheduled. A 24 hour urine collection or UPCR should be conducted at most three days before the next dose. If there is less than 2g protein per 24 hours or a UPCR 0-1 administer the bevacizumab and return to dipstick monitoring. If there is more than 2g protein per 24 hours omit the bevacizumab. Repeat the 24 hour urine collection prior to the next scheduled dose. If this is less than 2g per 24 hours administer the bevacizumab and continue 24 hour urine collection until the protein is 1g per 24 hours or less. Capecitabine NCI-CTC Grade 2 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue at the same dose. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 then resume therapy at 75% of the original dose. If the same adverse effect develops on a third occasion once more interrupt treatment until it resolves to grade 01 then continue at 50% of the original dose. Stop treatment if the toxicity re-appears on a fourth instance. NCI-CTC Grade 3 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue treatment using 75% of the original dose with prophylaxis if appropriate. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 and then resume therapy at 50% of the original dose. If the same adverse effect develops on a third occasion discontinue capecitabine. NCI-CTC Grade 4 Discontinue treatment unless the responsible consultant considers it to be in the best interest of the patient to continue at 50% of the original dose once the toxicity has resolved to NCI-CTC grade 0-1. When capecitabine is stopped for toxicity the doses are omitted, not delayed. Version 1.1 (Nov 2020) Page 4 of 8 Colorectal-Bevacizumab-Capecitabine Regimen 21 day cycle for 6 cycles Drug Bevacizumab Capecitabine Dose 7.5mg/kg 1000mg/m2 twice a day Days 1 1-14 Administration Intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes (see administration information) Oral Dose Information • Bevacizumab will be dose banded in accordance with the national dose bands (25mg/ml NS) • Capecitabine will be dose banded in accordance with the national dose bands Administration Information Extravasation • Bevacizumab - neutral Other • The first infusion of bevacizumab will be over 90 minutes. If this is well tolerated the second infusion may be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes • Capecitabine should start on the evening of day 1 • Capecitabine should be taken with or after food Additional Therapy • Antiemetics As take home medication - metoclopramide 10mg oral three times a day for 3 days then when required • Oral loperamide 4mg initially then 2mg after each loose stool when required for the relief of diarrhoea (maximum 16mg/24 hours). • Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines Version 1.1 (Nov 2020) Page 5 of 8 Colorectal-Bevacizumab-Capecitabine • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • Ensure the total daily dose of capecitabine is divided into two doses given twelve hours apart (the first should be administered in the evening of day one of the cycle). Serious toxicity has occurred where the total daily dose has been given twice a day. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. References 1. Cunningham D, Lang I, Marcuello E et al. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open label, randomised phase 3 trial. Lancet Oncol 2013; 14 (11): 1077-1085. Version 1.1 (Nov 2020) Page 6 of 8 Colorectal-Bevacizumab-Capecitabine REGIMEN SUMMARY Bevacizumab-Capecitabine Day 1 1. Bevacizumab 7.5mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Take home medicines 2. Capecitabine 1000mg/m2 oral twice a day for 14 days starting on the evening of day one of the cycle 3. Metoclopramide 10mg oral three times a day when required for the relief of nausea. Version 1.1 (Nov 2020) Page 7 of 8 Colorectal-Bevacizumab-Capecitabine DOCUMENT CONTROL Version Date Amendment Written By Approved By Updated monitoring with DPD testing 1.1 Nov 2020 Dose banding statement updated Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Coding removed 1 Nov 2014 Dr Deborah Wright Pharmacist Dr T Iveson Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.1 (Nov 2020) Page 8 of 8 Colorectal-Bevacizumab-Capecitabine
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Bevacizumab-Capecitabine.pdf

Docetaxel (75) Ver 1.1

Description: Chemotherapy Protocol BREAST CANCER DOCETAXEL (75) Regimen Breast Cancer – Docetaxel (75) Indication Treatment of locally advanced or metastatic HER2 positive breast cancer that has failed to adequately respond to an anthracycline containing therapy or when further anthracycline therapy is contra-indicated WHO Performance status 0, 1, 2 Toxicity Drug Docetaxel Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen FBC, U&E’s and LFT’s prior to each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing cycle one the following treatment criteria must be met; Version 1.1 (Oct 2014) Page 1 of 6 Breast –Docetaxel (75) Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L (unless due to bone marrow impairment) equal to or more than 100x109/L (unless due to bone marrow impairment) Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL Toxicity Neutrophil Febrile Neutropenia Platelets Grade (NCI-CTC) 1 2 3 4 3 4 Greater than or equal to 100x109/L Less than 100x109/L 75mg/m2 60mg/m2 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 75mg/m2 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Stop Stop Stop 60mg/m2 Delay until greater than or equal to 100x109/L the 60mg/m2 Stop Kidney Impairment Drug Docetaxel Creatinine Clearance (ml/min) N/A Dose (% of original dose) No dose adjustment needed Liver Impairment Drug Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN 1.5xULN or greater and/or 3.5xULN or greater and 2.5xULN or greater and 6xULN or greater Dose (% of original dose) Give 75% Not Recommended Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Version 1.1 (Oct 2014) Page 2 of 6 Breast –Docetaxel (75) Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2 once the neuropathy has resolved to NCI-CTC grade 2 or below. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops consider stopping treatment. Excessive tearing / lacrimation are related to cumulative docetaxel doses and occur after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 80% of the original dose in the first instance. Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCI-CTC grade 4 cutaneous toxicity. Regimen Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation) consider a starting dose of 55mg/m² with a view to increase to 75mg/m² if well tolerated. 21 day cycle for 6 cycles Drug Docetaxel Dose 75mg/m2 Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Dose Information Docetaxel will be dose banded as per the CSCCN agreed bands Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses Administration Information Hypersensitivity reactions tend to occur with the first or second infusion of docetaxel. The docetaxel infusion should not be interrupted for minor symptoms such as flushing or localised rashes. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. Docetaxel doses of more than 200mg should be diluted in 500ml sodium chloride 0.9% (maximum concentration 0.74mg/ml) Extravasation Docetaxel – exfoliant Version 1.1 (Oct 2014) Page 3 of 6 Breast –Docetaxel (75) Additional Therapy Antiemetics 15-30 minutes before chemotherapy - metoclopramide 10mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice a day orally for three days starting 24 hours before the docetaxel administration. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone premedication administer dexamethasone 20mg, or nearest equivalent dose, once only intravenous bolus. Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Coding Procurement – X71.1 Delivery – X72.3 References 1. NICE (2009). Clinical Guideline CG81. Advanced breast cancer: Diagnosis and Treatment. DOH:London. Version 1.1 (Oct 2014) Page 4 of 6 Breast –Docetaxel (75) REGIMEN SUMMARY Docetaxel (75) Cycle 1, 2, 3, 4, 5 Day Minus One 1. Dexamethasone 8mg twice a day oral* Day One 2. Dexamethasone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion 6. Metoclopramide 10mg three times a day when required oral Cycle 6 Day Minus One 1. Dexamethasone 8mg twice a day oral* Day One 2. Dexamethasone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Metoclopramide 10mg three times a day when required oral 6. Dexamethasone 8mg twice a day oral for the day after chemotherapy* * In Aria Planner the dexamethasone 8mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The administration instructions reflect this. On the last cycle no dexamethasone will appear for prescribing. Version 1.1 (Oct 2014) Page 5 of 6 Breast –Docetaxel (75) DOCUMENT CONTROL Version Date Amendment Header changed Toxicities removed Adverse effects tabulated ≥ removed and written in full Dose modification tabulated Regimen tabulated 1.1 August 2014 Nearest equivalent dose added to dexamethasone premedication Metoclopramide dose changed to 10mg Bolus removed from intravenous bolus throughout text OPCS code updated Disclaimer added 1 Dec 2011 None Written By Donna Kimber Pharmacy Technician Anna Bunch Pharmacist Dr Debbie Wright Pharmacist Approved By Dr Debbie Wright Pharmacist Dr Ellen Copson Consultant Medical Oncologist Dr Caroline Archer Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.1 (Oct 2014) Page 6 of 6 Breast –Docetaxel (75)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Docetaxel-75-Ver-11.pdf

Preparing for surgery - patient information

Description: This booklet contains important information on how to prepare for surgery.
Url: /Media/UHS-website-2019/Patientinformation/Surgery/Preparing-for-surgery-3167-PIL.pdf

MyelomaMPTMelphalan(PO)PrednisoloneThalidomideVer1

Description: Chemotherapy Protocol MULTIPLE MYELOMA MPT-MELPHALAN (PO)-PREDNISOLONE-THALIDOMIDE Regimen Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide Indication First line treatment of multiple myeloma in patients who or are unsuitable for bone marrow transplantation Second line or subsequent treatment of relapsed or progressive multiple myeloma in those with renal impairment who are not eligible for a transplant Toxicity Drug Melphalan Prednisolone Thalidomide Adverse Effect Gastro-intestinal disturbances, stomatitis, nausea, vomiting, alopecia, myalgia, muscle atrophy and fibrosis Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Drowsiness, constipation, dizziness, increased risk of thromboembolic events, dry skin/rash, peripheral neuropathy, teratogenicity, syncope, bradycardia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring FBC, LFTs and U&Es every 4 weeks Paraprotein or light chains every 4 weeks Pregnancy testing in women of childbearing potential. A negative pregnancy test must be obtained within 3 days of starting thalidomide the test must be repeated every 4 weeks (every 2 weeks in women with irregular menstrual cycles) with the final test 4 weeks after the last dose of thalidomide. Regular monitoring of blood glucose is considered good practice Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1 (May 2016) Page 1 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion or erythropoietin if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Dose modifications based on haematological parameters apply to melphalan only. Neutrophils (x109/L) 1 or greater less than 1 Platelets (x109/L) 75 or above less than 75 Dose Modifications (melphalan) 100% Delay treatment for up to 2 weeks until the neutrophils are 1x109/L or above and then continue with full dose and growth factor support and/or dose reduction. If recovery takes longer than 2 weeks consider stopping treatment. Dose Modifications (melphalan) 100% Delay treatment for up to 2 weeks until the platelets are 75x109/L or above and then continue with reduced dose. If recovery takes longer than 2 weeks consider stopping treatment. Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Melphalan Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment necessary Thalidomide N/A N/A No dose modification required Version 1 (May 2016) Page 2 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide Renal Impairment Drug Melphalan Creatinine Clearance (ml/min) 30 or greater less than 30 Dose (% of original dose) 100% Initiate treatment at 75%, increase at subsequent cycles if tolerated Thalidomide N/A No dose modification required Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Thalidomide Peripheral Neuropathy If NCI-CTC grade 1 neurological toxicity occurs treatment may be continued, if symptoms worsen consider dose reduction or interruption. Treatment may be reintroduced at a reduced dose if symptoms resolve. If NCI-CTC grade 2 neurological toxicity occurs suspend treatment or reduce the dose by at least 50%. Treatment may be reintroduced at a reduced dose if symptoms resolve to grade 1 or below. For NCI-CTC neurological toxicity grade 3 or above or toxicity that does not resolve despite treatment interruption / dose reduction thalidomide treatment should be stopped. Thromboembolism The thrombotic risk for patients commencing on thalidomide must be assessed. Appropriate thromboprophylaxis must be prescribed according to local policies. Thromboprophylaxis is generally recommended for at least the first 5 months of thalidomide treatment, especially in patients with additional thrombotic risk factors. Patients and their carers should be made aware of the symptoms of thromboembolism and advised to report sudden breathlessness, chest pain, or swelling of a limb. The occurrence of a thromboembolic event such as a DVT or thromboembolism, notably pulmonary embolism, is an indication for full anticoagulation following standard treatment guidelines. Thalidomide may be stopped, but can be re-introduced, initially at 50mg daily with escalation at subsequent cycles to 100mg, assuming good anticoagulant control and no other untoward side effects. All patients should be initially prescribed a low molecular weight heparin at the appropriate prophylactic dose. Therapeutic warfarin is an alternative to low molecular heparin. Aspirin 75mg each morning is an alternative in very low risk patients once a response has been obtained. Version 1 (May 2016) Page 3 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide Teratogenicity Thalidomide is highly teratogenic. All prescribers, patients and pharmacy staff must comply with the manufacturer’s Pregnancy Prevention Programme. Women of child-bearing potential taking thalidomide must use one agreed effective method of contraception for at least 4 weeks before starting thalidomide, while on thalidomide and for one month after. They must have a negative pregnancy test within 3 days prior to starting treatment. Pregnancy testing should be repeated monthly thereafter until one month after stopping thalidomide (or every 2 weeks in women with irregular menstrual cycles). If a woman taking thalidomide thinks she may be pregnant she must stop the drug immediately and seek medical advice. Men taking thalidomide must use a barrier method of contraception throughout treatment and for one week after stopping, if their partner is capable of bearing children. Other For other thalidomide related toxicities of NCI-CTC grade 3 or above. Stop thalidomide until recovery to NCI-CTC grade 1 or below. Cautious reintroduction of thalidomide at a dose of 50mg a day may be considered with dose escalation if tolerated. Prednisolone For patients who are unable to tolerate the standard dose of prednisolone the dose may be reduced or omitted as appropriate. Regimen 28 day cycle continued until plateau plus two cycles (6 cycles will be set in ARIA) There are different versions of this protocol in use. Check you have the intended version. Cycle 1 Drug Melphalan Prednisolone Dose 7mg/m2 40mg/m2 Days 1, 2, 3, 4 1, 2, 3, 4 Administration Oral Oral Thalidomide 50mg 1-28 incl. Oral Cycle 2 onwards Drug Melphalan Prednisolone Thalidomide Version 1 (May 2016) Dose 7mg/m2 40mg/m2 100mg Days 1, 2, 3, 4 Administration Oral 1, 2, 3, 4 Oral 1-28 incl. Oral Page 4 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide Dose Information Melphalan dose will be rounded to the nearest 2mg (up if halfway) Melphalan is available as 2mg tablets Prednisolone dose will be rounded to the nearest 5mg (up if halfway) Prednisolone is available as 5mg and 25mg tablets Thalidomide is available as 50mg capsules. Administration Information Melphalan tablets should be stored in the fridge Prednisolone should be taken in the morning, with or after food Thalidomide should be taken at night to avoid daytime drowsiness Additional Therapy Anti-emetics As take home medication - metoclopramide 10mg three times a day oral when required Thromboprophylaxis according to local formulary choice. For example; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Allopurinol 300mg once a day oral for 7 days on cycle one only Consider anti-infective prophylaxis in high risk patients, including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only Laxatives as required for thalidomide-induced constipation. Bisphosphonates in accordance with local policies Mouthwashes according to local or national policy on the treatment of mucositis. Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Version 1 (May 2016) Page 5 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide Additional Information The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. For all patients taking thalidomide; the patient, prescriber, and supplying pharmacy must comply with an appropriate pregnancy prevention programme. Every thalidomide prescription must be accompanied by a complete Prescription Authorisation Form. Coding Procurement – X70.4 Delivery – X73.1 References 1. Palumbo A, Bringhen S, Liberati AM et al. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood (2008);112:3107–3114. Version 1 (May 2016) Page 6 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide REGIMEN SUMMARY MPT-Melphalan (PO)-Prednisolone-Thalidomide Cycle 1 Take Home Medicines 1. Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 2. Melphalan 7mg/m2 once a day for 4 days oral Administration Instructions Tablets should be stored in a refrigerator. Oral chemotherapy. 3. Prednisolone 40mg/m2 once a day in the morning for 4 days oral Administration Instructions Take in the morning with or after food. 4. Thalidomide 50mg once a day for 28 days oral Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Only available as 50mg capsules, please ensure dose modifications occur in multiples of 50mg. Take at night to avoid daytime drowsiness. 5. Metoclopramide 10mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please supply 28 tablets or nearest original pack size 6. Allopurinol 300mg once a day for 7 days oral Administration Instructions Take with or after food with plenty of water. Please supply 7 days. 7. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 8. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 9. Thromboprophylaxis according to local formulary choice. For example; Administration Instructions The choice of thromboprophylaxis is dependent on local formulary choice and may include; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 28 days or nearest original pack size. Version 1 (May 2016) Page 7 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide 10. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack size. Cycle 2 onwards Take Home Medicines 11. Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 12. Melphalan 7mg/m2 once a day for 4 days oral Administration Instructions Tablets should be stored in a refrigerator. Oral chemotherapy 13. Prednisolone 40mg/m2 once a day in the morning for 4 days oral Administration Instructions Take in the morning with or after food. 14. Thalidomide 100mg once a day at night for 28 nights oral Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Only available as 50mg capsules, please ensure dose modifications occur in multiples of 50mg. Take at night to avoid daytime drowsiness. 15. Metoclopramide 10mg up to three times a day when required oral Administration Instructions Please supply 28 tablets or equivalent original pack size 16. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 17. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 18. Thromboprophylaxis Administration Instructions The choice of thromboprophylaxis is dependent on local formulary choice and may include; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 28 days or nearest original pack size. Version 1 (May 2016) Page 8 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide 19. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack size. Version 1 (May 2016) Page 9 of 10 Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 May 2016 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Dr Mathew Jenner Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1 (May 2016) 10 Page 10 of Multiple Myeloma – MPT-Melphalan (PO)-Prednisolone-Thalidomide
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E(100)CT

Description: Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-DOCETAXEL-EPIRUBICIN (100) Regimen (E100CT) • Breast Cancer – Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Indication • Neo-adjuvant / adjuvant therapy of breast cancer • WHO Performance status 0, 1, 2 Toxicity Drug Cyclophosphamide Docetaxel Epirubicin Adverse Effect Dysuria, haemorrhagic cystitis, taste disturbances Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Cardio-toxicity, urinary discolouration (red) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen • FBC, U&E’s and LFT’s prior to each cycle. • Ensure adequate cardiac function before starting treatment. Baseline LVEF should be measured, particularly in patients with a history of cardiac problems or in the elderly. Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1 (Nov 2020) Page 1 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met on day 1 of treatment. Criteria Neutrophils Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL In the adjuvant / neo-adjuvant setting always check with the relevant consultant before delaying or reducing the dose in response to a toxicity. For the EC arm of treatment. If counts on day one are below these criteria for neutrophil and/or platelets then delay treatment for seven days. Treatment should only be started when these levels are reached. On subsequent cycles, if the counts are below these levels on day one then delay treatment until these levels are reached and / or consider reducing the dose of epirubicin to 75% of the original dose. The dose intensity of cyclophosphamide may be maintained. If a second episode of neutropenia / thrombocytopenia occurs or the time to reach the eligible level is longer than seven days consider changing treatment. If patients experience febrile neutropenia or treatment delay due to neutrophil less than 0.5x109/L or platelets less than 50x109/L for more than a week, then reduce the dose to 75% of the original dose. If neutropenia or thrombocytopenia recurs, the dosage should be either further reduce to 50% of the original dose or stop treatment. For docetaxel the following table applies. Version 1 (Nov 2020) Page 2 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Toxicity Neutrophil Febrile Neutropenia Platelets Grade (NCI-CTC) 1 2 3 4 3 4 Greater than or equal to 100x109/L Less than 100x109/L Previous Docetaxel Dose 100mg/m2 75mg/m2 60mg/m2 100mg/m2 Delay until grade 1 then 100mg/m2 Delay until grade 1 then 100mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 100mg/m2 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 75mg/m2 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Stop Stop Stop 60mg/m2 Delay until greater than or equal to 100x109/L then 75mg/m2 Delay until greater than or equal to 100x109/L then 60mg/m2 Stop Version 1 (Nov 2020) Page 3 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Kidney Impairment Drug Cyclophosphamide Docetaxel Epirubicin Creatinine Clearance Dose (% of original (ml/min) dose) more than 20 100 10-20 75 Less than 10 50 No dose adjustment necessary Dose reduce in severe impairment only Liver Impairment Drug Cyclophosphamide Recommendation Dose reduction may not be necessary Epirubicin Bilirubin (umol/L) Dose (% of original) 24-51 50 51-85 25 85 or greater Contra-indicated If the AST 2-4xULN or the bilirubin is 21-51μmol/L give 50% of the dose, then if then AST is greater than 4xULN or the bilirubin is greater than 51μmol/L then give 25% dose Drug Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN 1.5xULN or greater and/or 3.5xULN or greater and 2.5xULN or greater and 6xULN or greater Dose (% of original dose) Give 75% Not Recommended Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Docetaxel Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 100mg/m2 to 75mg/m2. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 100mg/m2 or a NCI-CTC grade 4 toxicity develops CONSIDER stopping treatment. Excessive tearing / lacrimation are related to cumulative docetaxel doses and occur after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 80% of the original dose in the first instance. Version 1 (Nov 2020) Page 4 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced to from 100mg/m2 to 75mg/m2 or from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCICTC grade 4 cutaneous toxicity. Epirubicin Discontinue epirubicin if cardiac failure develops. Regimen The complete course of E100C is always administered first and is followed by docetaxel. E100C 21 day cycle for 3 cycles Drug Dose Days Administration Cyclophosphamide 500mg/m2 1 Intravenous bolus Epirubicin 100mg/m² 1 Intravenous bolus Docetaxel 21 day cycle for 3 cycles Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves, (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation), consider a starting dose of 75mg/m² with a view to increase to 100mg/m² if well tolerated. Drug Docetaxel Dose 100mg/m2 Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Dose Information • Cyclophosphamide will be dose banded in accordance with the national dose bands. • Docetaxel will be dose banded in accordance with the national dose bands. • Epirubicin will be dose banded in accordance with the national dose bands. • The maximum lifetime cumulative dose of epirubicin is 900mg/m². Version 1 (Nov 2020) Page 5 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Administration Information • Hypersensitivity reactions tend to occur with the first or second infusion of docetaxel. Docetaxel infusion should not be interrupted for minor symptoms such as flushing or localised rashes. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. Extravasation • Cyclophosphamide – neutral • Docetaxel – exfoliant • Epirubicin – vesicant Additional Therapy • E100C antiemetics day 1 15-30 minutes prior to chemotherapy; - aprepitant 125mg oral - dexamethasone 4mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication - aprepitant 80mg once a day for 2 days - dexamethasone 2mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two of the cycle Docetaxel 15-30 minutes before chemotherapy - metoclopramide 10mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral Version 1 (Nov 2020) Page 6 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) • To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice a day oral for three days starting 24 hours before docetaxel administration. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg as a once only dose intravenous bolus. The patient should be counselled to take the dexamethsone 8mg twice a day the following day. • Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for seven days starting on day three of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for seven days starting on day three of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two of the cycle • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. References 1.Roche H, Fumoleau P, Spielmann M et al. Sequential adjuvant Epirubicin based and Docetaxel chemotherapy for node positive breast cancer patients: the FNCLCC PACS 01 trial. J Clin Oncol 2006; 24 (36): 5664-5671. Version 1 (Nov 2020) Page 7 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) REGIMEN SUMMARY Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) E100C Cycle 1, 2 Day 1 1. Aprepitant 125mg oral 2. Dexamethasone 4mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Epirubicin 100mg/m² intravenous bolus over 10 minutes 5. Cyclophosphamide 500mg/m² intravenous bolus over 10 minutes Take Home Medicines 6. Aprepitant 80mg once a day for two days starting on day 2 of the cycle oral Administration Instructions Take 80mg once a day starting on day 2 of the cycle 7. Dexamethasone 2mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 2mg twice a day (morning and lunch) starting on day 2 of the cycle 8. Metoclopramide 10mg three times a day when required oral 9. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration Instructions Take 8mg twice a day (morning and evening) starting on the evening of day 1 of the cycle 10. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two Cycle 3 Day 1 11. Aprepitant 125mg oral 12. Dexamethasone 4mg oral or intravenous 13. Ondansetron 8mg oral or intravenous 11. Epirubicin 100mg/m² intravenous bolus over 10 minutes 12. Cyclophosphamide 500mg/m² intravenous bolus over 10 minutes Version 1 (Nov 2020) Page 8 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) Take Home Medicines 13. Aprepitant 80mg once a day for two days starting on day 2 of the cycle oral Administration Instructions Take 80mg once a day starting on day 2 of the cycle 14. Dexamethasone 2mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 2mg twice a day (morning and lunch) starting on day 2 of the cycle 15. Metoclopramide 10mg three times a day when required oral 16. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration Instructions Take 8mg twice a day (morning and evening) starting on the evening of day 1 of the cycle 17. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two 18. Dexamethasone 8mg twice a day oral for three days starting the day before the docetaxel infusion Administration Instructions Take 8mg twice a day (morning and lunch) for three days starting the day before the docetaxel infusion Docetaxel Cycle 4, 5 Day Minus 1 19. Dexamethasone 8mg twice a day oral* Day 1 20. Dexamethasone 8mg twice a day oral (from TTO)* 21. Metoclopramide 10mg oral or intravenous 22. Docetaxel 100mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 23. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion Administration Instructions Take 8mg twice a day (morning and lunch) for 3 days starting the day before the docetaxel infusion). This is the supply for the next cycle of treatment. 23. Metoclopramide 10mg three times a day oral when required Version 1 (Nov 2020) Page 9 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) 24. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for seven days starting on day three of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for seven days starting on day three of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two Cycle 6 Day Minus 1 25. Dexamethasone 8mg twice a day oral* Day 1 26. Dexamethasone 8mg twice a day oral (from TTO)* 27. Metoclopramide 10mg oral or intravenous 28. Docetaxel 100mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 29. Metoclopramide 10mg three times a day oral when required 30. Dexamethasone 8mg twice a day oral for the day after chemotherapy* 31. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for seven days starting on day three of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for seven days starting on day three of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two * In Aria Planner the dexamethasone 8mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The administration instructions reflect this. On the last cycle no dexamethasone will appear for prescribing. Version 1 (Nov 2020) Page 10 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Nov 2020 None Dr Debbie Wright Pharmacist Dr Chern Lee Consultant Medical Oncologist This protocol has been developed as part of the SACT electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1 (Nov 2020) Page 11 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100) (E100CT)
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Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT)

Description: Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-DOCETAXEL-EPIRUBICIN (100)- FLUOROURACIL Regimen (FE100CT) • Breast Cancer – Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Indication • Neo-adjuvant / adjuvant therapy of breast cancer • WHO Performance status 0, 1, 2 Toxicity Drug Cyclophosphamide Docetaxel Epirubicin Fluorouracil Adverse Effect Dysuria, haemorrhagic cystitis, taste disturbances Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Cardio-toxicity, urinary discolouration (red) Diarrhoea, stomatitis The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen • FBC, U&E’s and LFT’s prior to each cycle. • Ensure adequate cardiac function before starting treatment. Baseline LVEF should be measured, particularly in patients with a history of cardiac problems or in the elderly. • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with fluorouracil. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. Version 1.2 (November 2020) Page 1 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met on day 1 of treatment. Criteria Neutrophils Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL In the adjuvant / neo-adjuvant setting always check with the relevant consultant before delaying or reducing the dose in response to a toxicity. For the FEC arm of treatment. If counts on day one are below these criteria for neutrophil and/or platelets then delay treatment for seven days. Treatment should only be started when these levels are reached. On subsequent cycles, if the counts are below these levels on day one then delay treatment until these levels are reached and / or consider reducing the dose of epirubicin to 75% of the original dose. The dose intensity of cyclophosphamide and fluorouracil may be maintained. If a second episode of neutropenia / thrombocytopenia occurs or the time to reach the eligible level is longer than seven days consider changing treatment. If patients experience febrile neutropenia or treatment delay due to neutrophil less than 0.5x109/L or platelets less than 50x109/L for more than a week, then reduce the dose to 75% of the original dose. If neutropenia or thrombocytopenia recurs, the dosage should be either further reduce to 50% of the original dose or stop treatment. For docetaxel the following table applies. Version 1.2 (November 2020) Page 2 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Toxicity Neutrophil Febrile Neutropenia Platelets Grade (NCI-CTC) 1 2 3 4 3 4 Greater than or equal to 100x109/L Less than 100x109/L Previous Docetaxel Dose 100mg/m2 75mg/m2 60mg/m2 100mg/m2 Delay until grade 1 then 100mg/m2 Delay until grade 1 then 100mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Stop Stop Stop 100mg/m2 75mg/m2 60mg/m2 Delay until greater than or equal to 100x109/L then 75mg/m2 Delay until greater than or equal to 100x109/L then 60mg/m2 Stop Kidney Impairment Drug Cyclophosphamide Docetaxel Epirubicin Creatinine Clearance Dose (% of original (ml/min) dose) more than 20 100 10-20 75 Less than 10 50 No dose adjustment necessary Dose reduce in severe impairment only Fluorouracil Consider dose reduction in severe renal impairment only Version 1.2 (November 2020) Page 3 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Liver Impairment Drug Cyclophosphamide Recommendation Dose reduction may not be necessary Epirubicin Bilirubin (umol/L) Dose (% of original) 24-51 50 51-85 25 85 or greater Contra-indicated If the AST 2-4xULN or the bilirubin is 21-51μmol/L give 50% of the dose, then if then AST is greater than 4xULN or the bilirubin is greater than 51μmol/L then give 25% dose Drug Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN 1.5xULN or greater and/or 3.5xULN or greater and 2.5xULN or greater and 6xULN or greater Dose (% of original dose) Give 75% Not Recommended Drug Fluorouracil Bilirubin AST/ALT Dose µmol/L units (%of original dose) Less than 85 Less than 180 100% More than 85 or More than 180 CI In moderate hepatic impairment reduce the initial dose by one third. In severe hepatic impairment reduce initial dose by one half. These doses may be increased if no toxicity occurs Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Docetaxel Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 100mg/m2 to 75mg/m2. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 100mg/m2 or a NCI-CTC grade 4 toxicity develops CONSIDER stopping treatment. Excessive tearing / lacrimation are related to cumulative docetaxel doses and occur after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 80% of the original dose in the first instance. Version 1.2 (November 2020) Page 4 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced to from 100mg/m2 to 75mg/m2 or from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCICTC grade 4 cutaneous toxicity. Epirubicin Discontinue epirubicin if cardiac failure develops. Regimen The complete course of FE100C is always administered first and is followed by docetaxel. FE100C 21 day cycle for 3 cycles Drug Dose Days Administration Cyclophosphamide 500mg/m2 1 Intravenous bolus Epirubicin Fluorouracil 100mg/m² 500mg/m² 1 Intravenous bolus 1 Intravenous bolus Docetaxel 21 day cycle for 3 cycles Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves, (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation), consider a starting dose of 75mg/m² with a view to increase to 100mg/m² if well tolerated. Drug Docetaxel Dose Information Dose 100mg/m2 Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes • Cyclophosphamide will be dose banded in accordance with the national dose bands (20mg/ml PM) • Docetaxel will be dose banded in accordance with the national dose bands (20mg/ml) • Epirubicin will be dose banded in accordance with the national dose bands (2mg/ml PM) • The maximum lifetime cumulative dose of epirubicin is 900mg/m². Version 1.2 (November 2020) Page 5 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) • Fluorouracil will be dose banded in accordance with the national dose bands (25mg/ml PM) Administration Information • Hypersensitivity reactions tend to occur with the first or second infusion of docetaxel. Docetaxel infusion should not be interrupted for minor symptoms such as flushing or localised rashes. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. Extravasation • Cyclophosphamide – neutral • Docetaxel – exfoliant • Epirubicin – vesicant • Fluorouracil - inflammitant Additional Therapy • FE100C antiemetics day 1 15-30 minutes prior to chemotherapy; - dexamethasone 8mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication - dexamethasone 4mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 300microgram once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 263microgram once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two of the cycle Version 1.2 (November 2020) Page 6 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Docetaxel 15-30 minutes before chemotherapy - metoclopramide 10mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral • To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice a day oral for three days starting 24 hours before docetaxel administration. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg as a once only dose intravenous bolus. The patient should be counselled to take the dexamethsone 8mg twice a day the following day. • Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 300microgram once a day subcutaneous for seven days starting on day three of the cycle - lenograstim or bioequivalent 263microgram once a day subcutaneous for seven days starting on day three of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two of the cycle • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. References 1.Roche H, Fumoleau P, Spielmann M et al. Sequential adjuvant Epirubicin based and Docetaxel chemotherapy for node positive breast cancer patients: the FNCLCC PACS 01 trial. J Clin Oncol 2006; 24 (36): 5664-5671. Version 1.2 (November 2020) Page 7 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) REGIMEN SUMMARY Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) FE100C Cycle 1, 2 Day 1 1. Dexamethasone 8mg oral or intravenous 2. Ondansetron 8mg oral or intravenous 3. Epirubicin 100mg/m² intravenous bolus over 10 minutes 4. Fluorouracil 500mg/m² intravenous bolus over 10 minutes 5. Cyclophosphamide 500mg/m² intravenous bolus over 10 minutes Take Home Medicines 6. Dexamethasone 4mg twice a day for 3 days oral starting on day two of the cycle 7. Metoclopramide 10mg three times a day when required oral 8. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 9. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 300microgram once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 263microgram once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two FE100C Cycle 3 Day 1 1. Dexamethasone 8mg oral or intravenous 2. Ondansetron 8mg oral or intravenous 3. Epirubicin 100mg/m² intravenous bolus over 10 minutes 4. Fluorouracil 500mg/m² intravenous bolus over 10 minutes 5. Cyclophosphamide 500mg/m² intravenous bolus over 10 minutes Version 1.2 (November 2020) Page 8 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Take Home Medicines 6. Dexamethasone 4mg twice a day for 3 days oral starting on day two of the cycle 7. Metoclopramide 10mg three times a day when required oral 8. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 9. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 300microgram once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 263microgram once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two 10. Dexamethasone 8mg twice a day oral for three days starting the day before the docetaxel infusion Docetaxel Cycle 4, 5 Day Minus 1 1. Dexamethasone 8mg twice a day oral* Day 1 2. Dexamethasone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 100mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Dexamethasone 8mg twice daily oral for 3 days starting the day before the docetaxel infusion 6. Metoclopramide 10mg three times a day oral when required 7. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 300microgram once a day subcutaneous for seven days starting on day three of the cycle - lenograstim or bioequivalent 263microgram once a day subcutaneous for seven days starting on day three of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two Version 1.2 (November 2020) Page 9 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) Cycle 6 Day Minus 1 1. Dexamethasone 8mg twice a day oral* Day 1 2. Dexamethasone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 100mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Metoclopramide 10mg three times a day oral when required 6. Dexamethasone 8mg twice a day oral for the day after chemotherapy* 7. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 300microgram once a day subcutaneous for seven days starting on day three of the cycle - lenograstim or bioequivalent 263microgram once a day subcutaneous for seven days starting on day three of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two * In Aria Planner the dexamethasone 8mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The administration instructions reflect this. On the last cycle no dexamethasone will appear for prescribing. Version 1.2 (November 2020) Page 10 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT) DOCUMENT CONTROL Version Date Amendment Written By Approved By Updated monitoring with DPD 1.2 Nov 2020 testing Dose banding updated Coding removed Donna Kimber Pharmacy Technician Header changed Toxicities removed Adverse effects tabulated ≥ removed and written in full Dose modification tabulated Hepatic impairment updated Regimen tabulated 1.1 August 2014 Metoclopramide dose changed to 10mg Bolus removed from intravenous Donna Kimber Pharmacy Technician bolus throughout text Mucositis recommendation changed OPCS codes updated Dexamethasone TTO clarified Ondansetron TTO clarified Disclaimer added 1 Nov 2011 None Anna Bunch Pharmacist Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Dr Ellen Copson Consultant Medical Oncologist Dr Debbie Wright Pharmacist Dr Caroline Archer Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (November 2020) Page 11 of 11 Breast–Cyclophosphamide-Docetaxel-Epirubicin (100)-Fluorouracil (FE100CT)
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Cetuximab-Irinotecan (21day)

Description: Chemotherapy Protocol COLORECTAL CANCER CETUXIMAB-IRINOTECAN (21 day) This regimen may require funding Regimen • Colorectal Cancer–Cetuximab-Irinotecan (21 day) Indication • Metastatic colorectal cancer that is positive for the wild type KRAS genotype and that has progressed after failure of oxaliplatin and irinotecan based therapy. • WHO performance status 0, 1 Toxicity Drug Cetuximab Irinotecan Adverse Effect Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation Acute cholinergic syndrome, diarrhoea (may be delayed) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • Prior to starting therapy confirm a positive wild type KRAS status • FBC, LFT’s and U&E’s prior to day one of treatment • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.4 (October 2020) Page 1 of 10 Colorectal – Cetuximab-Irinotecan (21 day) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L and/or the platelets are less than 100x109/L then delay treatment for seven days If the counts recover at this time restart the irinotecan at 80% of the original dose. If a fourteen day delay is required to allow counts to recover or there are two separate delays of seven days during treatment consider reducing the dose of irinotecan to 50% of the original dose or stopping treatment. This is one of the few regimens where asymptomatic low nadir neutrophil counts are an indication for dose modification. Where this figure is less than 0.5x109/L or where there has been an episode of febrile neutropenia the subsequent irinotecan dose should be reduced to 80% of the original dose. There is little need to adjust the dose of cetuximab for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Drug Cetuximab Irinotecan Hepatic Renal Administer only when the Administer only where the serum transaminases are 5xULN or creatinine is 1.5xULN or below below and the bilirubin is 1.5xULN or below For the 350mg/m2 dose if the No adjustments are necessary bilirubin is 26 to 51umol/L although there is limited inclusive prescribe 200mg/m2. If information the bilirubin is above 51umol/L consider stopping therapy. Other Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reactions reduce the infusion rate by 50% (the total should not exceed 240 minutes). For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. Once the reaction has resolved to NCI-CTC grade 1 or below resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. Version 1.4 (October 2020) Page 2 of 10 Colorectal – Cetuximab-Irinotecan (21 day) If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acniform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions to 200mg/m2 and 150mg/m2 respectively. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of NCI-CTC grade 3 skin toxicity develops or a NCI-CTC grade 4 toxicity at any time. UV radiation may worsen skin reactions. Sun safety practices should be followed during and for up to two months after the end of treatment. Stop treatment if there is a confirmed pneumonitis. Irinotecan Irinotecan is associated with a number of toxic reactions. The next cycle of treatment should not be administered until all toxicities have resolved to 0 or 1 of the National Cancer Institute Common Toxicity Criteria scale (NCI-CTC). Seek advice if this takes longer than 14 days. Diarrhoea must have resolved completely. Where a NCI-CTC grade 2 to 4 non-haematological event has occurred the irinotecan dose must be reduced to 300mg/m2 in the first instance. If a second episode occurs despite this dose reduction delay until the symptoms have resolved and re-start the irinotecan at 250mg/m2. Stop treatment for a third episode. Regimen 21 day cycle for 6 cycles In those individuals who have had prior radical radiotherapy to the pelvis or who are 70 years of age and above or who have a performance status of 2 consider using a starting dose of irinotecan of 300mg/m2 (maximum dose 600mg). Cycle 1 Drug Cetuximab Cetuximab Irinotecan Dose 400mg/m2 250mg/m2 350mg/m2 Days 1 8, 15 1 Route Intravenous infusion over 120 minutes Intravenous infusion over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Version 1.4 (October 2020) Page 3 of 10 Colorectal – Cetuximab-Irinotecan (21 day) Cycle 2, 3, 4, 5, 6 Drug Cetuximab Irinotecan Dose 250mg/m2 350mg/m2 Days 1, 8, 15 1 Route Intravenous infusion over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Dose Information • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml) • Irinotecan will be dose banded in accordance with the national dose bands (20mg/ml) • The maximum daily dose of irinotecan is 700mg Administration Information Extravasation • Cetuximab – neutral • Irinotecan – irritant Other • Individuals should be monitored for hypersensitivity for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 10mg/min. The first infusion is given over 120 minutes. If this infusion rate is well tolerated subsequent infusions may be given over 60 minutes • Irinotecan may be administered over 30-90 minutes Additional Therapy • 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral Version 1.4 (October 2020) Page 4 of 10 Colorectal – Cetuximab-Irinotecan (21 day) • Antiemetics 15-30 minutes prior to chemotherapy on day one only - ondansetron 8mg oral As take home medication - dexamethasone 4mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral • Subcutaneous atropine 250microgram immediately prior to irinotecan for the prevention of acute cholinergic syndrome. A further 250microgram subcutaneous dose may be given to relieve cholinergic symptoms if they develop. • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed • Oral loperamide 4mg single dose after the first loose stool and then 2mg every two hours continued until 12 hours after the last liquid stool. Do not use for longer than 48 hours (maximum daily dose is 16mg). Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea. • Consider oral ciprofloxacin 500mg twice daily where diarrhoea continues for more than 24 hours. Review the patient before starting this treatment. Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea References 1. Cunningham D, Humblett Y, Sienna S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-335. 2. Wilke H et al. Cetuximab plus irinotecan in heavily pre-treated metastatic colorectal cancer progressing on irinotecan. The MABEL study. JCO 2008; 26 (33): 5335-5343. Version 1.4 (October 2020) Page 5 of 10 Colorectal – Cetuximab-Irinotecan (21 day) REGIMEN SUMMARY Cetuximab-Irinotecan (21 day) Day One Cycle One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 400mg/m2 over 120 minutes intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and the irinotecan 6. Atropine 250microgram subcutaneous for the prevention of irinotecan associated cholinergic symptoms 7. Ondansetron 8mg oral or intravenous 8. Irinotecan 350mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 9. Atropine 250microgram subcutaneous for the treatment of irinotecan associated cholinergic symptoms Take Home Medicines 10. Dexamethasone 4mg twice a day for 3 days oral starting the day after chemotherapy 11. Metoclopramide 10mg three times a day when required for the relief of nausea oral Version 1.4 (October 2020) Page 6 of 10 Colorectal – Cetuximab-Irinotecan (21 day) Cycle One Day Eight and Fifteen 12. Chlorphenamine 10mg intravenous 13. Dexamethasone 8mg oral or intravenous 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Cetuximab 250mg/m2 over 60 minutes intravenous infusion Day One Cycle Two Onwards 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 250mg/m2 over 60 minutes intravenous infusion 6. Atropine 250microgram subcutaneous for the prevention of irinotecan associated cholinergic symptoms 7. Ondansetron 8mg oral or intravenous Version 1.4 (October 2020) Page 7 of 10 Colorectal – Cetuximab-Irinotecan (21 day) 8. Irinotecan 350mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 9. Atropine 250microgram subcutaneous for the treatment of irinotecan associated cholinergic symptoms Take Home Medicines 10. Dexamethasone 4mg twice a day for 3 days oral starting the day after chemotherapy 11. Metoclopramide 10mg three times a day when required for the relief of nausea oral Day Eight and Fifteen Cycle Two Onwards 12. Chlorphenamine 10mg intravenous 13. Dexamethasone 8mg oral or intravenous 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Cetuximab 250mg/m2 over 60 minutes intravenous infusion Version 1.4 (October 2020) Page 8 of 10 Colorectal – Cetuximab-Irinotecan (21 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By Update of premedication due to shortage of IV ranitidine. 1.4 October 2020 IV ranitidine changed to H2 antagonist according to local formulary choice and availability Arum Shortland Pharmacist Dr Debbie Wright Pharmacist Coding removed Dose banding updated Header changed Bolus removed from chlorphenamine Irinotecan administration instructions added Metoclopramide dose changed 1.3 May 2014 to 10mg Atropine added as a standard Dr Debbie Wright Pharmacist Donna Kimber Pharmacy Technician treatment before irinotecan Dexamethasone administration route clarified Dexamethasone TTO clarified Coding updated Disclaimer added Duration if infusion of irinotecan changed from 30 minutes to 90 1.2 Oct 2012 minutes in the regimen and regimen summary. Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist OPCS delivery code changed from X72.2 to X72.1 & X72.4. In the treatment summary ondansetron moved to be given after the cetuximab but before 1.1 the irinotecan. Spelling of Nov 2011 chlorpheniramine changed to chlorphenamine and fifeteen to Dr Debbie Wright Pharmacist Rebecca Wills Pharmacist fifteen. In the additional therapy single dose of loperamide 4mg added. 1 Sept 2011 None Dr Debbie Wright Pharmacist Dr Tim Iveson Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust Version 1.4 (October 2020) Page 9 of 10 Colorectal – Cetuximab-Irinotecan (21 day) University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.4 (October 2020) Page 10 of 10 Colorectal – Cetuximab-Irinotecan (21 day)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Cetuximab-Irinotecan.pdf

Cetuximab (500)-Fluorouracil-Folinic Acid-Irinotecan

Description: Chemotherapy Protocol COLORECTAL CANCER CETUXIMAB(500)-FLUOROURACIL-FOLINIC ACID (Modified de Gramont)IRINOTECAN Regimen This regimen may require funding • Colorectal Cancer – Cetuximab(500)-Fluorouracil-Folinic Acid (modified de Gramont)-Irinotecan Indication • Cetuximab in combination with a fluoropyrimidine and irinotecan chemotherapy is recommended as a possible first or second line treatment for people with metastatic colorectal cancer when: - surgery to remove the cancer in the colon or rectum has been carried out or is possible - the metastases are only in the liver and cannot be removed surgically before treatment - the person is fit enough to have surgery to remove the cancer in the colon or rectum and to have liver surgery if it becomes possible to remove the metastases after cetuximab treatment - there is a contra-indication or the individual is intolerant to oxaliplatin • The tumour is positive for the wild type KRAS genotype • WHO performance status 0, 1 Toxicity Drug Cetuximab Fluorouracil Irinotecan Adverse Effect Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain Acute cholinergic syndrome, diarrhoea (may be delayed) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • Prior to starting therapy confirm a positive KRAS status • FBC, LFT’s and U&E’s prior to day one of treatment Version 1.3 (November 2020) Page 1 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with fluorouracil. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing on day one of cycle one the following criteria must be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L and/or the platelets are less than 100x109/L then delay treatment for seven days If the counts recover at this time restart the irinotecan at 80% of the original dose. If a 14 day delay is required to allow counts to recover or there are two separate delays of 7 days during treatment consider reducing the dose of irinotecan to 50% of the original dose or stopping treatment. This is one of the few regimens where asymptomatic low nadir neutrophil counts are an indication for dose modification. Where this figure is less than 0.5x109/L or where there has been an episode of febrile neutropenia the subsequent irinotecan and fluorouracil dose should be reduced to 80% of the original dose. There is little need to adjust the dose of cetuximab or folinic acid for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Version 1.3 (November 2020) Page 2 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan Drug Cetuximab Fluorouracil Irinotecan Hepatic Renal Administer only when the Administer only where the transaminases are 5xULN serum creatinine is or below and the bilirubin 1.5xULN or below is 1.5xULN or below If the bilirubin is more than A dose adjustment is only 85umol/L and / or the AST required in severe renal more than 180 fluorouracil impairment is contra-indicated. In moderate hepatic impairment consider reducing the dose by 30% and for severe impairment by 50% For the 350mg/m2 dose if No adjustments are the bilirubin is 26 to 51 necessary although there is umol/L inclusive prescribe limited information 200mg/m2. If the bilirubin is above 51umol/L consider stopping therapy. Other Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reaction reduce the infusion rate by 50%. For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. Once the reaction has resolved to NCI-CTC grade 1 or below resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acniform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of NCI-CTC grade 3 skin toxicity develops. Version 1.3 (November 2020) Page 3 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan Fluorouracil Diarrhoea occurring for the first time at NCI-CTC grade 2 should be approached by withholding the fluorouracil until it has resolved to NCI-CTC grade 1 or below. Treatment can then be re-started at full dose. Treatment should again be delayed on development of a second NCI-CTC grade 2 diarrhoea and the fluorouracil re-started at 75% of the original dose when it has resolved to NCI-CTC grade 1 or below. After resolution of a third episode of NCI-CTC grade 2 diarrhoea to NCI-CTC grade 1 or below, the fluorouracil should be re-started using 50% of the original dose. On appearance of a NCI-CTC grade 3 diarrhoea withhold fluorouracil until it has resolved to NCI-CTC grade 1 or below and re-start treatment using 75% of the original dose. After a second episode at NCI-CTC grade 3 wait until the diarrhoea has resolved to NCI-CTC grade 1 or below and resume the fluorouracil using 50% of the original dose. For a third appearance of NCI-CTC grade 3 diarrhoea or the development of NCI-CTC grade 4 toxicity at any time stop fluorouracil therapy. Irinotecan Irinotecan is associated with a number of toxic reactions. The next cycle of treatment should not be administered until all toxicities have resolved to 0 or 1 of the National Cancer Institute Common Toxicity Criteria scale (NCI-CTC) within fourteen days. Diarrhoea must have resolved completely. Where a NCI-CTC grade 2 to 4 nonhaematological event has occurred the irinotecan dose must be reduced to 150mg/m2 in the first instance. If a second episode occurs despite this dose reduction delay until the symptoms have resolved and re-start the irinotecan at 100mg/m2. Stop treatment for a third episode. Regimen 14 day cycle for 6 cycles Drug Cetuximab Fluorouracil Fluorouracil Folinic Acid Irinotecan Dose 500mg/m2 400mg/m2 2400mg/m2 350mg 180mg/m2 Days 1 1 1 1 1 Route Intravenous infusion (see administration) Intravenous bolus over 10 minutes Intravenous infusion over 46 hours Intravenous infusion in 250ml glucose 5% over 120 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Dose Information • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml NS) • Fluorouracil will be dose banded in accordance with the national dose bands (25mg/ml PM bolus and 50mg/ml infusion) Version 1.3 (November 2020) Page 4 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan • Irinotecan will be dose banded in accordance with the national dose bands (20mg/ml) Administration Information Extravasation • Cetuximab - neutral • Fluorouracil – inflammitant • Irinotecan - irritant Other • Central venous access and use of an ambulatory infusion pump is required • Individuals should be monitored for hypersensitivity for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 5mg/min for the first infusion (minimum 120 minutes). If this infusion rate is well tolerated subsequent infusions may be given at a rate of 10mg/min (minimum 60 minutes) • Irinotecan may be administered over 30-90 minutes Additional Therapy • 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral or intravenous - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral • Antiemetics 15-30 minutes prior to chemotherapy - ondansetron 8mg oral or intravenous As take home medication - dexamethasone 4mg twice a day oral for 3 days - metoclopramide 10mg three times a day when required oral Version 1.3 (November 2020) Page 5 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan • Subcutaneous atropine 250microgram immediately prior to irinotecan for the prevention of acute cholinergic syndrome. A further 250microgram subcutaneous dose may be given to relieve cholinergic symptoms if they develop. • Oral loperamide 2mg every two hours once first liquid stool appears and continue until 12 hours after the last liquid stool. Do not use for longer than 48 hours (maximum daily dose is 16mg). Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea • Consider oral ciprofloxacin 500mg twice daily where diarrhoea continues for more than 24 hours. Review the patient before starting this treatment. Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information • The folinic acid may be replaced with calcium levofolinate 175mg intravenous infusion in 250ml glucose 5% over 120 minutes References 1. Moosmann N, Heinemann V. Cetuximab plus XELIRI or XELOX for the first line therapy of metastatic colorectal cancer.Clin Colorectal Cancer 2008; 7 (2): 110-117. 2. van Custen E, Kohne CH, Lang I et al. Cetuximab plus irinotecan, fluorouracil and leucovorin as first line treatment for metastatic colorectal cancer: Updated analysis of overall survival according to tumour KRAS and BRAF mutation status. JCO 2011; 29: 1-10. Version 1.3 (November 2020) Page 6 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan REGIMEN SUMMARY Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan Day One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 500mg/m2 intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and the remaining chemotherapy 6. Atropine 250microgram subcutaneous 7. Ondansetron 8mg oral or intravenous 8. Irinotecan 180mg/m2 in 250ml sodium chloride 0.9% over 90 minutes intravenous infusion 9. Folinic Acid 350mg in 250ml glucose 5% over 120 minutes intravenous infusion 10. Fluorouracil 400mg/m2 over 10 minutes intravenous bolus 11. Fluorouracil 2400mg/m2 over 46 hours intravenous infusion 12. Atropine 250microgram subcutaneous when required for the treatment of irinotecan associated cholinergic symptoms Take Home Medicines 13. Dexamethasone 4mg twice a day oral for 3 days starting the day after irinotecan 14. Metoclopramide 10mg three times a day when required oral Version 1.3 (November 2020) Page 7 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan DOCUMENT CONTROL Version Date Amendment Update of premedication due to shortage of IV ranitidine. IV ranitidine changed to H2 antagonist according to local 1.3 Nov 2020 formulary choice and availability Coding removed Dose banding updated Updated monitoring with DPD testing 1.2 May 2014 Header changed Bolus removed from supportive therapies Irinotecan administration changed to 90 minutes Cetuximab administration changed in line with SPC Coding updated Metoclopramide dose changed to 10mg Disclaimer added Atropine added prior to irinotecan 1.1 Dec 2011 Numbers amended on the regimen summary page to run concurrently. Administration instruction for cetuximab added to the regimen summary page 500 added to the name of the regimen Ondansetron order of administration changed to be given after the cetuximab Footnote on page 7 changed from irinotecan to cetuximab Cycle one removed from the regimen section Day one removed from antiemetics Cetuximab dose modifications altered for skin toxicity. 1 Sept 2011 None Written By Donna Kimber Pharmacy Technician Dr Debbie Wright Pharmacist Dr Debbie Wright Pharmacist Dr Debbie Wright Pharmacist Approved By Rebecca Wills Pharmacist Donna Kimber Pharmacy Technician Donna Kimber Pharmacy Technician Dr Tim Iveson Consultant Medical Oncologist Version 1.3 (November 2020) Page 8 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.3 (November 2020) Page 9 of 9 Colorectal – Cetuximab(500)-Fluorouracil-Folinic Acid (MdG)-Irinotecan
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Cetuximab500-Fluorouracil-FolinicAcid-Irinotecan.pdf

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