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Etoposide PO
Description
Chemotherapy Protocol GYNAECOLOGICAL CANCER ETOPOSIDE ORAL Regimen Ovary-Etoposide Oral Indication Second line or subsequent treatment of recurrent platinum resistant ovarian cancer where other treatments are inappropriate. Palliative intent WHO performance status 0, 1, 2 Toxicity Drug Etoposide Adverse Effect Alopecia, hyperbilirubinaemia 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 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. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Version 1.1 (April 2014) Page 1 of 5 Ovary-Etoposide PO Prior to cycle 1 the following criteria must be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100 x109/L Day 1 - Dose modifications Neutrophils (x109/L) 1 or greater less than 1 Platelets (x109/L) Dose Modifications 100% Delay until recovery. Consider reducing course length or discontinuing treatment as appropriate. Dose Modifications 100 or greater less than 100 100% Delay until recovery. Consider reducing course length or discontinuing treatment as appropriate. Hepatic Impairment Drug Etoposide Bilirubin (μmol/L) 26-51 or 51 or greater or AST/ALT units 60-180 180 or greater Dose (% of original dose) Consider reducing course length Clinical decision Renal Impairment Drug Etoposide Creatinine Clearance (ml/min) 50 or greater 15-50 less than 15 Dose (% of original dose) 100% 75% 50% 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. Reduce the course length or discontinue as appropriate. Version 1.1 (April 2014) Page 2 of 5 Ovary-Etoposide PO Regimen 28 day cycle for 6 cycles Drug Etoposide Dose 50mg (flat dose) Days 1-21 Oral Administration Administration Information Etoposide to be taken an hour before food or on an empty stomach Additional Therapy Antiemetics As take home medication - metoclopramide 10mg oral three times a day as required 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 Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to oral etoposide. Coding Procurement – X70.1 Delivery – X73.1 References 1.Rose PG, Blessing JA, Mayer AR et al. Prolonged oral etoposide as second-line therapy for platinum-resistant and platinumsensitive ovarian carcinoma: a gynecologic oncology group study. J Clin Oncol 1998;16: 405-410. 2.Hoskins PJ, Swenerton KD. Oral etoposide is active against platinum-resistant epithelial ovarian cancer. J Clin Oncol 1994; 12: 60-63. 3.Seymour MT, Mansi JL, Gallagher CJ, et al. Protracted oral etoposide in epithelial ovarian cancer: a phase II study in patients with relapsed or platinum-resistant disease. Br J Cancer 1994; 69: 191-195. 4.Markman M, Hakes T, Reichman B et al. Phase 2 trial of chronic low-dose oral etoposide as salvage therapy of platinumrefractory ovarian cancer. J Cancer Res Clin Oncol 1992; 119; 55-57. Version 1.1 (April 2014) Page 3 of 5 Ovary-Etoposide PO REGIMEN SUMMARY Etoposide PO Day 1 1. Etoposide 50mg (flat dose) oral once a day for 21 days. 2. Metoclopramide 10mg oral three times a day when required Version 1.1 (April 2014) Page 4 of 5 Ovary-Etoposide PO DOCUMENT CONTROL Version Date Amendment Metoclopramide dose changed 1.1 April 2014 OPCS code updated Disclaimer updated 1 May 2013 None Written By Dr Deborah Wright Pharmacist Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Approved By Donna Kimber Pharmacy Technician Dr Clare Green Consultant Medical Oncologist Dr Cheng Yeoh 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 (April 2014) Page 5 of 5 Ovary-Etoposide PO
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Ovarian-cancer/EtoposidePO.pdf
Cyclophosphamide PO
Description
Chemotherapy Protocol GYNAECOLOGICAL CANCER CYCLOPHOSPHAMIDE ORAL Regimen Ovary – Cyclophosphamide Oral Indication Relapsed/refractory ovarian cancer in patients unsuitable for other treatments Palliative Performance status 0, 1, 2 Toxicity Drug Adverse Effect Cyclophosphamide Dysuria, haemorrragic cystitis (rare), taste disturbances The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFT’s and U&E’s prior to day one of treatment 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. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Version 1.1 (April 2014) Page 1 of 5 Ovary-Cyclophosphamide PO Day 1 Neutrophils (x109/L) 1 or greater less than 1 Platelets (x109/L) Dose Modifications 100% Withhold the cyclophosphamide until recovery to 1x109/L or greater. If recovered to this level within 7 days resume treatment at full the dose. If not recovered at this point delay until recovery then continue with 50mg on alternate days or discontinue as appropriate. Dose Modifications 75 or greater less than 75 100% Withhold the cyclophosphamide until recovery to 75x109/L or greater. If recovered to this level within 7 days resume treatment at full dose. If not recovered at this point delay until recovery then continue with 50mg on alternate days or discontinue as appropriate. Hepatic Impairment Drug Bilirubin (μmol/L) Cyclophosphamide 20 or greater or AST/ALT units 2-3xULN Dose (% of original dose) Clinical decision. Evidence that exposure to active metabolites may not be increased, suggesting dose reduction may not be necessary. Renal Impairment Drug Cyclophosphamide Creatinine Clearance (ml/min) 20 or greater 10-20 less than 10 Dose (% of original dose) 100% Consider 50mg on alternate days omit 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. Consider giving 50mg on alternate days or discontinue as appropriate. Version 1.1 (April 2014) Page 2 of 5 Ovary-Cyclophosphamide PO Regimen 28 day cycle for 6 cycles Drug Dose Cyclophosphamide 50mg (flat dose) Days Administration 1-28 incl. Oral Administration Information Cyclophosphamide to be taken with plenty of water swallowed whole, not chewed Additional Therapy Antiemetics As take home medication - metoclopramide 10mg oral three times a day when required 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 Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to oral cyclophosphamide. Coding (OPCS 4.6) Procurement – X70.1 Delivery – X73.1 ` References 1. Watanabe Y, Etoh T, Koike E et al. Feasibility study of oral cyclophosphamide salvage therapy for the treatment of heavily pre-treated patients with recurrent epithelial ovarian cancer. Int J Clin Oncol 2010; 16 (5): 468-471. 2. Garcia AA, Hirte H, Fleming G, et al.: Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia. J Clin Oncol 26 (1): 76-82, 2008. Version 1.1 (April 2014) Page 3 of 5 Ovary-Cyclophosphamide PO REGIMEN SUMMARY Cyclophosphamide PO Day 1 1. Cyclophosphamide 50mg (flat dose) oral once a day for 28 days 2. Metoclopramide 10mg oral three times a day when required Version 1.1 (April 2014) Page 4 of 5 Ovary-Cyclophosphamide PO DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.1 April 2014 Metoclopramide dose changed Disclaimer updated Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician 1 May 2013 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Dr Deborah Wright Consultant Medical Oncologist Dr Cheng Yeoh 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 (April 2014) Page 5 of 5 Ovary-Cyclophosphamide PO
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Ovarian-cancer/CyclophosphamidePO.pdf
Panitumumab (21 day) Ver 1.1
Description
Chemotherapy Protocol COLORECTAL CANCER PANITUMUMAB (21 day) This regimen may require funding and is an unlicensed dose Regimen Colorectal Cancer – Panitumumab (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 or who are intolerant to these agents. WHO performance status 0, 1, 2 Toxicity Drug Adverse Effect Panitumumab Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation 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 cycle one and every 6 – 9 weeks thereafter 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 1.1 (May 2014) Page 1 of 5 Colorectal – Panitumumab (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 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 For haematological toxicity, if the neutrophil count is less than 1.5 109/L or the platelet count less than 100 109/L, delay treatment until these levels are achieved. The decision to continue treatment should be made at the consultant’s discretion. Hepatic / Renal Impairment Drug Panitumumab Hepatic No information available Renal No information available Other Allergic or hypersensitivity reactions have occurred during the administration of panitumumab. 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 panitumumab 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 90% of those receiving panitumumab. 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 panitumumab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. Reinstate therapy using 50% of the original dose. If the reaction does not recur escalate the dose in 25% increments as tolerated until the recommended dose is reached. If the reactions do not resolve to less than NCI-CTC grade 2 after withholding up to two doses or if the skin toxicity recurs or becomes intolerable at 50% of the original dose discontinue treatment. Version 1.1 (May 2014) Page 2 of 5 Colorectal – Panitumumab (21 day) 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. Regimen 21 day cycle until intolerance or disease progression (6 cycles will be set) Drug Panitumumab Dose 9mg/kg Days 1 Route Intravenous infusion in 100ml sodium chloride 0.9% over 60 minutes Dose Information Panitumumab will be dose banded according to the CSCCN agreed bands Administration Information Extravasation Panitumumab - neutral Other Panitumumab must be administered using a 0.22 micron in-line filter Doses of 1000mg and above must be administered over 90 minutes in 150ml sodium chloride 0.9% Additional Therapy Antiemetics As take home medication - metoclopramide 10mg three times a day when required oral (supply on day one of cycle one only and then as required) 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 – X71.5 Delivery – X72.3 References 1. Van Cutsem E, Peeters M, Siena S et al. Open label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy refractory metastatic colorectal cancer. J Clin Oncol 2007; 25: 1658-1664. Version 1.1 (May 2014) Page 3 of 5 Colorectal – Panitumumab (21 day) REGIMEN SUMMARY Panitumumab (21 day) Day One 1. Panitumumab 9mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 60 minutes* 2. Metoclopramide 10mg three times a day when required for the relief of nausea oral** *Please refer to the administration instructions *The metoclopramide will only appear on day one cycle one. If further supplies are required they should be added from the support directory of Aria as necessary. Version 1.1 (May 2014) Page 4 of 5 Colorectal – Panitumumab (21 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed Metoclopramide dose changed 1.1 May 2014 to 10mg throughout Set in Aria removed from Dr Debbie Wright Pharmacist Donna Kimber Pharmacy Technician number of cycles Disclaimer added 1 Feb 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 1.1 (May 2014) Page 5 of 5 Colorectal – Panitumumab (21 day)
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Panitumumab21dayVer11.pdf
Fluorouracil Folinic Acid
Description
Chemotherapy Protocol COLORECTAL CANCER FLUOROURACIL and FOLINIC ACID (Modified de Gramont) Regimen • Colorectal Cancer– Fluorouracil and Folinic Acid (Modified de Gramont) Indication • Treatment of advanced / metastatic colorectal cancer • Adjuvant treatment of stage II - III colon cancer following surgery • WHO performance status 0, 1, 2 Toxicity Drug Fluorouracil Adverse Effect 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, LFT’s and U&E’s prior to day one of treatment • 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. Version 1.2 (November 2020) Page 1 of 5 Colorectal - Fluorouracil and Folinic Acid (MdG) Haematological Prior to prescribing 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 Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL For haematological toxicity, if the neutrophil count is less than 1.5 109/L or the platelet count is less than 75 109/L, delay treatment until these levels are achieved. Reinitiate therapy at the full dose for up to a 7 day delay or for a delay of more than 7 days with 75% of the original dose for thrombocytopenia. If neutropenia is the issue, then after 7 days omit the bolus fluorouracil for this and subsequent cycles. If a further delay is necessary despite omitting the bolus fluorouracil then reduce the dose of the infusional fluorouracil to 80% of the original dose. If the delay is 21 days or more then stop therapy. There is no need to dose adjust the folinic acid for haematological counts. 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. Dose limiting toxicities include diarrhoea, abdominal pain, emesis, stomatitis and palmar-plantar erythrodysesthesia among others. Kidney / Liver Impairment Drug Fluorouracil Hepatic Renal 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% Regimen 14 day cycle for 6 - 12 cycles Drug Fluorouracil Fluorouracil Folinic Acid Dose 400mg/m2 2800mg/m2 350mg Version 1.2 (November 2020) Days 1 1 1 Route Intravenous bolus over 10 minutes Intravenous infusion over 46 hours Intravenous infusion in 250ml glucose 5% over 120 minutes Page 2 of 5 Colorectal - Fluorouracil and Folinic Acid (MdG) Dose Information • Fluorouracil will be dose banded in accordance with the national dose bands (25mg/ml PM bolus and 50mg/ml infusion) Administration Information Extravasation • Fluorouracil – inflammitant Other • Central venous access and use of an ambulatory infusion pump is required. Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy - metoclopramide 10mg oral or intravenous As take home medication; - metoclopramide 10mg three times a day when required oral • Oral loperamide 4mg after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). • 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. Seymour MT, Wilson G, Dent JT et al. Dose escalation study of a modified “de Gramont” regimen, better suited to the chemotherapy day unit. Ann Oncol (1998); Version 1.2 (November 2020) Page 3 of 5 Colorectal - Fluorouracil and Folinic Acid (MdG) REGIMEN SUMMARY Day One 1. Metoclopramide 10mg oral or intravenous 2. Folinic Acid 350mg in 250ml glucose 5% over 120 minutes intravenous infusion 3. Fluorouracil 400mg/m2 intravenous bolus over 10 minutes 4. Fluorouracil 2800mg/m2 intravenous infusion over 46 hours Take Home Medicines 5. Metoclopramide 10mg three times a day when required oral Version 1.2 (November 2020) Page 4 of 5 Colorectal - Fluorouracil and Folinic Acid (MdG) 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 Rebecca Wills Pharmacist 1.1 May 2014 Header changed Toxicity rating removed Tabulation throughout Renal and hepatic dose Dr Deborah Wright Donna Kimber reductions updated Pharmacist Pharmacy Technician Bolus removed throughout Fluorouracil bolus administration changed to 10 minutes Pyridoxine removed from supportive therapies Metoclopramide dose changed to 10mg throughout Dexamethasone TTO clarified Disclaimer added Dr Debbie Wright Dr Tim Iveson 1 Aug 2010 None Pharmacist 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 5 of 5 Colorectal - Fluorouracil and Folinic Acid (MdG)
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Fluorouracil-Folinic-Acid.pdf
ColorectalTrifluridineTipiricilVer1
Description
Chemotherapy Protocol Regimen COLORECTAL CANCER TRIFLURIDINE-TIPIRACIL Colorectal Cancer – Trifluridine-Tipiracil Indication Trifluridine-tipiracil is recommended as a third or subsequent line of therapy for treating metastatic colorectal cancer in adults who have had previous treatment with available treatments including a fluoropyrimidine, oxaliplatin or irinotecan based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and antiepidermal growth factor receptor (EGFR) agents, or when these therapies are not suitable, only when the company provides trifluridine–tipiracil hydrochloride with the discount agreed in the patient access scheme. Performance status 0, 1, 2 Toxicity Drug Adverse Effect Trifluridine-Tipiracil Diarrhoea, nausea, neutropenia, thrombocytopenia, proteinuria, fatigue, decreased appetite The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring FBC, U&Es and LFTs prior to day one of treatment. Urine testing for protein on day one 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. Haematological Dosing adjustments may be required based on individual safety and tolerability. A maximum of three dose reductions are permitted, at 5mg/m2 increments, from 35mg/m2 to Version 1 (Oct 2016) Page 1 of 5 Colorectal-Trifluridine-Tipiracil 30mg/m2, 25mg/m2 to a minimum dose of 20 mg/m2 of trifluridine twice a day. Dose escalation is not permitted after it has been reduced. In the event of haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in the table below. Parameter Neutrophils Platelets Interruption criteria less than 0.5×109/L less than 50×109/L Resumption criteria greater than or equal to 1.5×109/L greater than or equal to 75×109/L Resumption criteria applied to the start of the next cycle for all patients regardless of whether or not the interruption criteria were met. Adverse reaction Febrile neutropenia or a CTCAE grade 4 neutropenia (less than 0.5x109/L) or thrombocytopenia (less than 25×109/L) that results in more than one week's delay in the start of next cycle. Recommended dose modifications • Interrupt dosing until toxicity resolves to CTCAE grade 1 or baseline. • When resuming dosing, decrease the dose level by 5 mg/m2 of the trifuridine dose from the previous dose level to a minimum of 20mg/m2 trifluridine Consider blood transfusion or erythropoietin if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Hepatic Impairment No adjustment of the starting dose is recommended in patients with mild hepatic impairment. It is not recommended in patients with moderate or severe hepatic impairment. Renal Impairment No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment. Administration is not recommended in severe renal impairment or end stage renal disease. 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. Regimen 28 day cycle until disease progression or intolerance (12 cycles will be set in Aria) The dose is calculated based on the trifluridine dose. Drug Trifluridine-Tipiracil Dose 35mg/m2 twice a day Days Administration 1, 2, 3, 4, 5, 8, 9, 10, 11, 12 Oral Version 1 (Oct 2016) Page 2 of 5 Colorectal-Trifluridine-Tipiracil Dose Information The dose is calculated based on the trifluridine dose The maximum dose is 80mg of trifluridine The minimum dose is 20mg/m2 of trifluridine Doses will be rounded to the nearest 5mg (up if half way) Administration Information The dosage schedule is easier to remember if it is started on a Monday and taken through to the Friday with the weekend off. If a dose is missed or with held the patient must not make up the doses The tablets are available in two strengths, 15mg/6.14mg and 20mg/8.19mg trifluridine and tipiracil (as the hydrochloride) respectively. Additional Therapy Anti-emetics are not routinely required but you may consider adding - metoclopramide 10mg three times a day oral when required Antidiarrhoeal agents such as loperamide or codeine. 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. 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. Coding Procurement – X71.5 Delivery – X73.1 References 1. Mayer R, van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N et al. Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer. N Engl J Med 2015;372:1909-19. Version 1 (Oct 2016) Page 3 of 5 Colorectal-Trifluridine-Tipiracil REGIMEN SUMMARY Trifluridine-Tipiracil Take Home Medicines Cycle 1 onwards Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12 1. Trifluridine – Tipiracil 35mg/m2 twice a day oral Administration Instructions The dose is based on the dose of trifluridine Version 1 (Oct 2016) Page 4 of 5 Colorectal-Trifluridine-Tipiracil DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Oct 2016 None Dr Deborah 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 that occur as a result of following these guidelines. Version 1 (Oct 2016) Page 5 of 5 Colorectal-Trifluridine-Tipiracil
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/ColorectalTrifluridineTipiricilVer1.pdf
Everolimus Ver 1
Description
Chemotherapy Protocol PANCREATIC NEUROENDOCRINE CARCINOMA EVEROLIMUS This protocol may require funding Regimen PNET - Everolimus Indication The first or second line treatment of moderately differentiated PNET carcinomas Performance status 0, 1 Toxicity Drug Everolimus Adverse Effect Diarrhoea, rash, dry skin, fatigue, non-infectious pneumonitis, increased risk of infection, hyperglycaemia, hypertriglyceridaemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring FBC, U&Es and LFTs every 4 weeks Blood glucose levels at baseline and after 4 weeks of treatment. Thereafter every 4-8 weeks Triglycerides at baseline then every 8 weeks 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. Haematological Consider blood transfusion or the prescription of an erythropoietin produce according to NICE TA 323 if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Version 1 (June 2015) Page 1 of 6 PNET-Everolimus Neutrophils (x109/L) Dose Modifications 1 or greater Full dose 0.5 - 1 less than 0.5 or NCI-CTC grade 3 febrile neutropenia NCI-CTC grade 4 febrile neutropenia Platelets (x109/L) 1st Occurrence Interrupt treatment until recovery to 1x109/L or greater then restart at the full dose 2nd Occurrence Interrupt treatment until recovery to 1x109/L or greater then restart at 5mg once a day 1st Occurrence Interrupt treatment until the fever has resolved and the neutrophils are 1x109/L or greater then restart at 5mg once a day 2nd Occurrence Discontinue treatment permanently Discontinue treatment permanently Dose Modifications 75 or greater 50-75 25-50 less than 25 Full dose 1st Occurrence Interrupt treatment until recovery to 75x109/L or greater then restart at the full dose 2nd Occurrence Interrupt treatment until recovery to 75x109/L or greater then restart at 5mg once a day 1st Occurrence Interrupt treatment until recovery to 75x109/L or greater then restart at 5mg once a day 2nd Occurrence Discontinue treatment permanently Discontinue treatment permanently Hepatic Impairment Drug Everolimus Child Pugh Class A B C Dose 10mg once a day 5mg once a day Not recommended Version 1 (June 2015) Page 2 of 6 PNET-Everolimus Renal Impairment Drug Creatinine Clearance (ml/min) Dose (% of original dose) Everolimus 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. 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 5mg once a day or discontinued as appropriate. Mucositis NCI-CTC Grade 2 3 or recurrence of grade 2 mucositis 4 or recurrence of grade 3 mucositis Action Continue the everolimus without dose adjustments if the patient can tolerate it. Alternatively interrupt until symptoms have resolved to NCICTC grade 1 or below and then re-challenge at the same dose Interrupt treatment until symptoms have resolved to NCI-CTC grade 1 or below then restart the everolimus at 5mg once a day Discontinue everolimus Pneumonitis NCI-CTC Grade 1 2 3 4 Action Continue everolimus without dose adjustments Interrupt therapy. Consider short term use of corticosteroids e.g. prednisolone 20mg once a day for 10-14 days. Restart everolimus at 5mg once a day when symptoms have resolved. Interrupt therapy. Prescribe corticosteroids e.g. prednisolone 40mg as indicated. Restart everolimus at 5mg daily once symptoms have resolved or discontinue as appropriate. Discontinue the everolimus. Treat appropriately. Regimen 28 day cycle continued as long as clinical benefit is observed or until unacceptable toxicity occurs (6 cycles will be set in Aria) Drug Everolimus Dose 10mg once a day Days 1-28 incl. Administration Oral Version 1 (June 2015) Page 3 of 6 PNET-Everolimus Dose Information Everolimus is available as 2.5mg, 5mg and 10mg tablets. Administration Information Take at the same time of day every day with or without food, but not after a high fat meal. If a dose is missed do not take an additional but rather take the next scheduled dose Additional Therapy Mouthcare for the prophylaxis or treatment of mucositis in accordance with CSCCN guidelines. Avoid mouthwashes containing alcohols. 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 Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to everolimus. It must be made clear to all staff, including those in the community, that everolimus should only be prescribed under the supervision of an oncologist. Everolimus interacts with many other agents. Always check for drug interactions. Coding Procurement – X71.5 Delivery – X73.1 References 1. Yao JC, Shah MH, Ito T et al. Everolimus for advanced pancreatic neuroendocrine tumours. N Engl J Med 2011; 364 (6): 514-23. Version 1 (June 2015) Page 4 of 6 PNET-Everolimus REGIMEN SUMMARY Everolimus Day 1 1. Everolimus 10mg once a day oral Administration Instructions Please supply an original pack per 28 day cycle Version 1 (June 2015) Page 5 of 6 PNET-Everolimus DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 May 2015 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Dr Judith Cave 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 Trust All actions have been taken to ensure these protocols are correct. However, it remains the responsibility of the prescriber to ensure the correct drugs and doses are prescribed for patients. Version 1 (June 2015) Page 6 of 6 PNET-Everolimus
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Endocrinecancer/Everolimus-Ver-1.pdf
Temozolomide (200)
Description
Chemotherapy Protocol Central Nervous System TEMOZOLOMIDE (200) Regimen • CNS – Temozolomide (200) Indication • Recurrent or progressive malignant glioblastoma multiforme in patients not previously treated with chemotherapy • Performance status 0, 1 Toxicity Drug Temozolomide Adverse Effect Hepatic injury, thrombocytopenia, nausea and vomiting, Pneumocystis jirovecii infection The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, LFT’s, U&E’s and glucose on day 22 of the cycle • Clinical examination including neurological assessment, whole brain imaging and chest x-ray prior to starting treatment (in recurrent disease) 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 1.1 (Feb 2019) Page 1 of 6 CNS – Temozolomide (200) Haematological Prior to starting treatment 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. During treatment a complete blood count should be obtained on day 22 (21 days after the first dose of temozolomide). Temozolomide can be restarted, at a reduced dose, provided the neutrophils have recovered to 1x109/L and platelets 100x109/L within seven days of the planned administration date, or administration discontinued according to the tables below. Toxicity Neutrophil Platelet Reduce dose by 50mg/m2 0.5 - 1x109/L 10 - 100x109/L Discontinue temozolomide less than 0.5x109/L less than 10x109/L Temozolomide is to be discontinued if a dose of 100mg/m2 still results in unacceptable toxicity or the same NCI CTC grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. Hepatic Impairment Toxicity Bilirubin more than 1.5xULN ALT more than 2.5xULN Action Stop temozolomide Stop temozolomide Renal Impairment Drug Action Temozolomide No dose reductions are required. Caution in severe renal impairment 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 2 toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. For toxicity that is NCI-CTC grade 3 or above discontinue treatment. Version 1.1 (Feb 2019) Page 2 of 6 CNS – Temozolomide (200) Regimen 28 day cycle for 6 cycles Drug Temozolomide Dose Days 200mg/m2 (maximum 400mg) 1, 2, 3, 4, 5 Administration Oral Dose • Temozolomide will be dose banded in accordance with the national dose bands (temozolomide oral) • The dose of temozolomide will be capped at 2m2 Administration Information • Temozolomide should be taken on an empty stomach • Temozolomide to be taken with plenty of water swallowed whole, not chewed Additional Therapy Antiemetics • As take home medication - ondansetron 8mg 15 – 30 minutes prior to temozolomide • Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday until lymphocytes are above 0.8 • 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 Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to oral temozolomide. Coding • Procurement – X71.1 • Delivery – X73.1 Version 1.1 (Feb 2019) Page 3 of 6 CNS – Temozolomide (200) References 1.National Institute for Health and Clinical Excellence (2007). NICE TA 121. Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma. DOH: London 2.National Institute for Clinical Excellence (2001). NICE TA 23: Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer). DOH: London 3.Stupp et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005; 352: 987-96 Version 1.1 (Feb 2019) Page 4 of 6 CNS – Temozolomide (200) REGIMEN SUMMARY Temozolomide (200) Cycle 1 - 6 Take Home Medicines 1. Temozolomide 200mg/m2 oral once a day for 5 days Administration Instructions Take on an empty stomach, swallow whole, do not chew 2. Ondansetron 8mg once a day 15-30 minutes prior to the temozolomide Administration Instructions An additional 8mg may be taken 12 hours later if required for the relief of nausea or vomiting. Please supply an original pack (10 tablets) or nearest appropriate equivalent Version 1.1 (Feb 2019) Page 5 of 6 CNS – Temozolomide (200) DOCUMENT CONTROL Version Date Amendment Written By Lymphocyte dose adjustment removed. Donna Kimber 1.1 Feb 2019 Dose rounding changed to dose Pharmacy bands Technician Disclaimer updated 1 Oct 2015 None Dr Deborah Wright Pharmacist Approved By Dr Deborah Wright Pharmacist Dr Omar Al Salihi Consultant Clinical 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 that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1.1 (Feb 2019) Page 6 of 6 CNS – Temozolomide (200)
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/CNS/Temozolomide-200.pdf
Governor elections 2019: the results
Description
Voting has closed, and we are pleased to announce the results of the 2019 election to join the Council of Governors.
Url
/AboutTheTrust/Newsandpublications/Latestnews/2019/September/Governor-elections-2019-the-results.aspx
Can patients rely on their advance decisions?
Description
Advance decisions allow an adult to refuse lifesaving treatment in a future where they envisage they may lack capacity to deliver that refusal personally. But can patients rely on them?
Url
/HealthProfessionals/Clinical-law-updates/Can-patients-rely-on-their-advance-decisions.aspx
Trust fellowship Application Form Final AR
Description
Clinical Doctoral Research Fellowship Scheme 2019 Details of Applicant Full Name: Title: Telephone No: Contact Address: Email Address: Current Post: Current AfC Band: Name of Manager: Unit/ Care Group: Education Date of initial registration as health professional: Title of undergraduate degree: Degree classification: Awarding institution: Date awarded: Any post graduate qualification e.g. PgCert, PGDip, MSc? Name of award: Awarding institution: Date of awarded: Authorisation PLEASE ENSURE THAT YOU HAVE ATTACHED THE FOLLOWING DOCUMENTS TO YOUR EMAIL: 1. A short CV (MAX OF 2 PAGES) 2. APPLICATION FORM 3. EXPRESSION OF INTEREST STATEMENT, including description of topic of interest Email to:Soar@uhs.nhs.uk Signature of applicant: Date: Manager’s Name: Post Held by Manager: Manager’s Signature: Telephone No: Manager’s email Address:
Url
/Media/Southampton-Clinical-Research/SoAR/Trust-fellowship-Application-Form-Final-AR.docx
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