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ARC SETT project EOI v2 final

Description
Building analytic capability to address compound pressure across health and care systems: testing an approach. Expression of interest: Operat
Url
/Media/Southampton-Clinical-Research/Downloads/ARC-SETT-project-EOI-v2-final.pdf

Letrozole-Palbociclib

Description
Chemotherapy Protocol Breast Cancer Letrozole-Palbociclib Regimen • Breast Cancer – Letrozole-Palbociclib Indication • Palbociclib in combination with an aromatase inhibitor is indicated for the treatment previously untreated, hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancer that is not amenable to curative treatment and where; - the patient has had no prior treatment with a CDK 4/6 inhibitor unless either ribociclib has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or palbociclib has been received as part of the compassionate use scheme and the patient meets all the other criteria - the patient is male or is female and either post-menopausal or if pre- or perimenopausal has undergone ovarian ablation or suppression with LHRH agonist treatment - the patient has had no previous hormone therapy for locally advanced or metastatic disease i.e. is hormone therapy naïve for locally advanced/metastatic breast cancer. Previous hormone therapy with anastrozole or letrozole whether as adjuvant therapy or as neoadjuvant treatment is allowed as long as the patient has had a disease-free interval of 12 months or more since completing treatment with anastrazole or letrozole. - WHO performance status of 0 – 2 Toxicity Treatment breaks of up to 6 weeks are allowed for palbociclib but solely to allow toxicities to settle. Drug Letrozole Palbociclib Adverse Effect Osteoporosis, headache, somnolence, hot flushes, alopecia, arthralgia, rash, vaginal dryness, asthenia, liver abnormalities, depression, insomnia Infection, myelosuppression, peripheral neuropathy, fatigue, mucositis, anorexia, eye disorders, venous thromboembolism The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (Feb 2018) 1 Breast – Letrozole-Palbociclib Monitoring Drugs • FBC, LFTs and U&Es at baseline and then on day one of each cycle (every twenty-eight days). • For cycle one and two only the FBC should be assessed on day one and fourteen of the cycle (the full cycle of palbociclib may be dispensed on day 1) 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 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. Consider blood transfusion or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or has haemoglobin of less than 8g/dL (80g/L) Prior to prescribing cycle 1 the following criteria must be met. Criteria Neutrophils Platelets Eligible Level Equal to or more than 1.0x109/L Equal to or more than 100x109/L Thereafter dose adjustments for haematological toxicity are described in the table below; Version 1 (Feb 2018) 2 Breast – Letrozole-Palbociclib Toxicity Grade Palbociclib dose Haematological 1 or 2 No change Day 1: Delay one week. When recovered to NCI-CTC grade 2 or below restart at same dose Day 14 of first 2 cycles: continue current dose to complete 3 the cycle. Repeat the FBC on day 21. Consider dose reduction if the recovery to eligible levels takes 7 days or longer or there is recurrent NCI-CTC grade 3 neutropenia in subsequent cycles 3 with Delay until recovery to NCI-CTC grade 2 or below. Restart at fever next lower dose level 4 Delay until recovery to NCI-CTC grade 2 or below. Restart at next lower dose level Neutropenia was the most frequently reported adverse effect of palbociclib with a median onset of 15 days for any grade and 28 days for NCI-CTC grade 3 or 4. Median duration of severe neutropenia was seven days and most patients had their palbociclib dose reduced or held. No dose reductions are required for letrozole due to myelosuppression. Hepatic Impairment No dose change for letrozole is recommended in patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment No dose adjustments of palbociclib are required for patients with mild hepatic impairment (total bilirubin less than r equal to 1xULN and aspartate aminotransferase [AST] greater than 1×ULN, or total bilirubin greater than 1 to 1.5×ULN and any AST). Insufficient data are available in patients with moderate or severe hepatic impairment (total bilirubin greater than1.5×ULN and any AST) to provide any dose adjustment recommendation. Administer palbociclib to patients with moderate and severe hepatic impairment only after careful consideration of the potential benefits and risks and with close monitoring of signs of toxicity. Renal Impairment No dose change is recommended for letrozole in patients with mild or moderate renal impairment. In patients with severe renal impairment, administration of letrozole should be performed with caution No dose adjustments of palbociclib are required for patients with mild to moderate renal impairment (creatinine clearance [CrCl] more than or equal to 30ml/min). Insufficient data are available in patients with severe renal impairment (CrCl less than 30ml/min) or requiring haemodialysis to provide any dose adjustment recommendation. Administer palbociclib to patients with severe renal impairment only after careful consideration of the potential benefits and risks and with close monitoring of signs of toxicity. Version 1 (Feb 2018) 3 Breast – Letrozole-Palbociclib Other Doses for other toxicities should be adjusted according to the table below; Dose Level 0 -1 -2 Palbociclib Dose (mg/day) 125 100 75 Letrozole dose (mg/day) 2.5 2.5 2.5 Toxicity NonHaematological Grade Palbociclib dose 1 or 2 No change 3 or 4 Delay until recovery to NCI-CTC Restart at next lower dose level. grade 2 or below. Infections were reported more frequently in the palbociclib combination treatment arm versus the single agent aromatase inhibitor alone arm and may be severe. Patients should be warned of the increased risk of infection and promptly report any occurrences of fever to their health care team. Regimen 28 day cycle until disease progression or intolerance (twelve cycles will be set in ARIA) Ovarian ablation or suppression with a LHRH agonist is mandatory is patients who are pre or peri menopausal due to the pharmacology of palbociclib and aromatase inhibitors in combination. This is not included in the regimen on ARIA. Drug Letrozole Palbociclib Dose 2.5mg per day 125mg per day Days Days 1-28 inclusive Days 1-21 inclusive Route Oral Oral Dose Information • Letrozole is available as 2.5mg tablets • Palbociclib is available as 125mg, 100mg and 75mg capsules Administration Information • Palbociclib should be taken with food. If the patient vomits or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time • Palbociclib capsules should be swallowed whole and not chewed. Version 1 (Feb 2018) 4 Breast – Letrozole-Palbociclib Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) mustbe followed in relation to palbociclib • It must be made clear to all staff, including those in the community, that palbociclib should only be prescribed under the supervision of a consultant oncologist • Palbociclib interacts with many other agents. Always check for drug interactions. • Ovarian ablation or suppression with a LHRH agonist is mandatory is patients who are pre or peri menopausal due to the pharmacology of palbociclib and aromatase inhibitors in combination. • Treatment breaks of up to 6 weeks are allowed but solely to allow toxicities to settle Coding • Procurement - X • Delivery – X References 1. Finn RS, Martin M, Rugo H et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med (2016); 375: 1925-1936. Version 1 (Feb 2018) 5 Breast – Letrozole-Palbociclib REGIMEN SUMMARY Letrozole-Palbociclib Day One 1. Letrozole 2.5mg once a day for 28 days oral 2. Palbociclib 125mg once a day for 21 days oral Administration Instructions Oral chemotherapy Palbociclib is taken from day 1 to day 21 of a 28 day cycle. Swallow capsules whole do not chew. Take with or after food Version 1 (Feb 2018) 6 Breast – Letrozole-Palbociclib DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Feb 2018 None Dr Deborah Wright Pharmacist Dr Jenny Bradbury 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 (Feb 2018) 7 Breast – Letrozole-Palbociclib
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Letrozole-Palbociclib.pdf

Exemestane-Palbociclib

Description
Chemotherapy Protocol Breast Cancer Exemestane-Palbociclib Regimen • Breast Cancer – Exemestane-Palbociclib Indication • Palbociclib in combination wit
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Exemestane-Palbociclib.pdf

Anastrozole-Palbociclib

Description
Chemotherapy Protocol Breast Cancer Anastrozole-Palbociclib Regimen • Breast Cancer – Anastrozole-Palbociclib Indication • Palbociclib in combination w
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Anastrozole-Palbociclib.pdf

Abemaciclib-Letrozole

Description
Chemotherapy Protocol Breast Cancer Abemaciclib-Letrozole Regimen • Breast Cancer – Abemaciclib-Letrozole Indication • Abemaciclib in combination with
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Abemaciclib-Letrozole.pdf

Bevacizumab (15) Carboplatin-Paclitaxel (21 day)

Description
Chemotherapy Protocol GYNAECOLOGICAL CANCER BEVACIZUMAB (15)-CARBOPLATIN (AUC5)-PACLITAXEL (21 day) Regimen • Cervix-Bevacizumab (15)-Carboplatin
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Cervical-cancer/Bevacizumab-15-Carboplatin-Paclitaxel-21-day.pdf

Doxorubicin-Olaratumab

Description
Chemotherapy Protocol SARCOMA DOXORUBICIN-OLARATUMAB Regimen • Sarcoma – Doxorubicin-Olaratumab Indication • In combination with doxorubicin for the first line t
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Sarcoma/Doxorubicin-Olaratumab.pdf

Letrozole-Ribociclib

Description
Chemotherapy Protocol Breast Cancer Letrozole-Ribociclib Regimen • Breast Cancer – Letrozole-Ribociclib Indication • Ribociclib in combination with an aromatase inhibitor is indicated for the treatment previously untreated, hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancer that is not amenable to curative treatment and where; - the patient has had no prior treatment with a CDK 4/6 inhibitor unless either palbociclib has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or ribociclib has been received as part of the compassionate use scheme and the patient meets all the other criteria - the patient is male or is female and either post-menopausal or if pre- or perimenopausal has undergone ovarian ablation or suppression with LHRH agonist treatment - the patient has had no previous hormone therapy for locally advanced or metastatic disease i.e. is hormone therapy naïve for locally advanced/metastatic breast cancer. Previous hormone therapy with anastrozole or letrozole whether as adjuvant therapy or as neoadjuvant treatment is allowed as long as the patient has had a disease-free interval of 12 months or more since completing treatment with anastrazole or letrozole. - WHO performance status of 0 – 2 Toxicity Treatment breaks of up to 6 weeks are allowed for ribociclib but solely to allow toxicities to settle. Drug Letrozole Ribociclib Adverse Effect Osteoporosis, headache, somnolence, hot flushes, alopecia, arthralgia, rash, vaginal dryness, asthenia, liver abnormalities, depression, insomnia Infection, myelosuppression, peripheral neuropathy, fatigue, mucositis, anorexia, eye disorders, venous thromboembolism, cadiac abnormalities The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (Feb 2018) 1 Breast – Letrozole-Ribociclib Monitoring Drugs • FBC, LFTs and U&Es at baseline and then on day one of each cycle (every twenty-eight days). • For cycle one and two only the FBC and LFTs should be assessed on day one and fourteen of the cycle (the full cycle of ribociclib may be dispensed on day 1) • ECG should be assessed before initiating treatment with ribociclib. After initiating treatment, ECG should be repeated at approximately day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated. In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended. 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 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. Consider blood transfusion or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or has haemoglobin of less than 8g/dL (80g/L) Prior to prescribing cycle 1 the following criteria must be met. Criteria Neutrophils Platelets Eligible Level Equal to or more than 1.0x109/L Equal to or more than 100x109/L Thereafter dose adjustments for haematological toxicity are described in the table below; Version 1 (Feb 2018) 2 Breast – Letrozole-Ribociclib Toxicity Grade Ribociclib dose Haematological 1 or 2 No change Day 1: Delay one week. When recovered to NCI-CTC grade 2 or below restart at same dose Day 14 of first 2 cycles: continue current dose to complete 3 the cycle. Repeat the FBC on day 21. Consider dose reduction if the recovery to eligible levels takes 7 days or longer or there is recurrent NCI-CTC grade 3 neutropenia in subsequent cycles 3 with Delay until recovery to NCI-CTC grade 2 or below. Restart at fever next lower dose level 4 Delay until recovery to NCI-CTC grade 2 or below. Restart at next lower dose level Neutropenia was the most frequently reported adverse effect of ribociclib with a median onset of 15 days for any grade and 28 days for NCI-CTC grade 3 or 4. Median duration of severe neutropenia was seven days and most patients had their ribociclib dose reduced or held. No dose reductions are required for letrozole due to myelosuppression. Hepatic Impairment No dose change for letrozole is recommended in patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment Ribcoclib in Hepatic Impairment NCI-CTC Grade 1 No dose adjustment NCI-CTC Grade 2 No dose adjustment NCI-CTC Grade 3 Delay treatment until recovery to NCI-CTC grade 2 or below, then resume at the same dose level.If a NCI-CTC grade 2 toxicity recurs resume traement at the lower dose level NCI-CTC Grade 4 Interupt the dose until recovery to NCI-CTC grade 2 or below then resume at the next lowest dose level. Discontinue of NCI- CTC toxicity recurs. Combination If patients develop ALT and/or AST greater than 3xULN along with total bilirubin greater than 2xULN irrespective of baseline grade, discontinue ribociclib Renal Impairment No dose change is recommended for letrozole in patients with mild or moderate renal impairment. In patients with severe renal impairment, administration of letrozole should be performed with caution No dose adjustments of ribociclib are required for patients with mild to moderate renal impairment (creatinine clearance [CrCl] more than or equal to 30ml/min). Insufficient data are available in patients with severe renal impairment (CrCl less than 30ml/min) or requiring haemodialysis to provide any dose adjustment recommendation. Administer ribociclib to patients with severe renal impairment only after careful consideration of the potential benefits and risks and with close monitoring of signs of toxicity. Version 1 (Feb 2018) 3 Breast – Letrozole-Ribociclib Other Doses for other toxicities should be adjusted according to the table below; Dose Level 0 -1 -2 Ribociclib Dose (mg/day) 600 400 200 Letrozole dose (mg/day) 2.5 2.5 2.5 Ribociclib should be discontinued if the 200mg dose is not tolerated. Ribociclib Dose Adjustments Other non- NCI-CTC Grade 1 haematologic or 2 al or cardiac No dose toxicities adjustment is required. Initiate appropriate medical therapy and monitor as clinically indicated. NCI-CTC Grade 3 NCI-CTC Grade 4 Dose interruption until recovery to NCI-CTC grade 1 or below, then resume ribociclib at the same dose level. If NCI-CTC grade 3 recurs, resume ribociclib at the next lower dose level. Discontinue ribociclib Infections were reported more frequently in the ribociclib combination treatment arm versus the single agent aromatase inhibitor alone arm and may be severe. Patients should be warned of the increased risk of infection and promptly report any occurrences of fever to their health care team. Cardiac ECGs with QTcF greater than 480msec ECGs with QTcF greater than 500msec 1. The dose should be interrupted. 2. If QTcF prolongation resolves to less than 481msec, resume treatment at the same dose level. 3. If QTcF greater than or equal to 481msec recurs, interrupt dose until QTcF resolves to less than 481msec and then resume ribociclib at the next lower dose level. If QTcF is greater than 500msec on at least 2 separate ECGs, interrupt ribociclib until QTcF is less than 481msec then resume ribociclib at next lower dose level. If QTcF interval prolongation to greater than 500msec or greater than 60msec change from baseline occurs in combination with torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia, permanently discontinue ribociclib Version 1 (Feb 2018) 4 Breast – Letrozole-Ribociclib Regimen 28 day cycle until disease progression or intolerance (twelve cycles will be set in ARIA) Ovarian ablation or suppression with a LHRH agonist is mandatory is patients who are pre or peri menopausal due to the pharmacology of ribociclib and aromatase inhibitors in combination. This is not included in the regimen on ARIA. Drug Letrozole Ribociclib Dose 2.5mg per day 600mg per day Days Days 1-28 inclusive Days 1-21 inclusive Route Oral Oral Dose Information • Letrozole is available as 2.5mg tablets • Ribociclib is available as 200mg tablets Administration Information • Ribociclib should be taken with or without food. If the patient vomits or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time. Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) mustbe followed in relation to ribociclib • It must be made clear to all staff, including those in the community, that ribociclib should only be prescribed under the supervision of a consultant oncologist • Ribociclib interacts with many other agents. Always check for drug interactions. • Ovarian ablation or suppression with a LHRH agonist is mandatory is patients who are pre or peri menopausal due to the pharmacology of ribociclib and aromatase inhibitors in combination. Coding • Procurement - X70.8 • Delivery – X73.1 References 1. Hortobagyi GN, Stemmer SN, Burris HA et al. Ribociclib as first line therapy for HR positive advanced breast cancer. N Engl J Med (2016); 375 (18): 1738-1748. Version 1 (Feb 2018) 5 Breast – Letrozole-Ribociclib REGIMEN SUMMARY Letrozole-Ribociclib Day One 1. Letrozole 2.5mg once a day for 28 days oral 2. Ribociclib 600mg once a day for 21 days oral Administration Instructions Oral chemotherapy Ribociclib is taken from day one to day 21 of a 28 day cycle. Take with or without food Version 1 (Feb 2018) 6 Breast – Letrozole-Ribociclib DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Feb 2018 None Dr Deborah Wright Pharmacist Dr Jenny Bradbury 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 (Feb 2018) 7 Breast – Letrozole-Ribociclib
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Letrozole-Ribociclib.pdf

Fulvestrant-Palbociclib

Description
Chemotherapy Protocol Breast Cancer Fulvestrant-Palbociclib Regimen • Breast Cancer – Fulvestrant-Palbociclib Indication Palbociclib with fulvestr
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Fulvestrant-Palbociclib.pdf

Exemestane-Ribociclib

Description
Chemotherapy Protocol Breast Cancer Exemestane-Ribociclib Regimen • Breast Cancer – Exemestane-Ribociclib Indication • Ribociclib in combination with a
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Exemestane-Ribociclib.pdf
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