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Clinical Research in Southampton
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Irinotecan-Temozolomide
Description
Chemotherapy Protocol Sarcoma IRINOTECAN - TEMOZOLOMIDE Regimen • Sarcoma – Irinotecan-Temozolomide Indication •
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Sarcoma/Irinotecan-Temozolomide.pdf
Sorafenib version 1.1
Description
Chemotherapy Protocol LIVER SORAFENIB This protocol may require funding Regimen Hepatocellular carcinoma-Sorafenib Indication Hepatocellular carcinoma where radical resection, liver transplant or locoregional treatment such as transcatheter arterial chemoembolisation (TACE), radio frequency ablation (RFA) or selective internal radiation therapy (SIRT) are not appropriate or where the disease has progressed following locoregional treatment. WHO performance status 0, 1, 2 Toxicity Drug Sorafenib Adverse Effect Palmar-plantar erythrodysaesthesia, hypertension, haemorrhage, cardiac ischaemia, QT interval prolongation, fatigue, hypophosphataemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics (SPC) for full details. Monitoring FBC, U&Es (including phosphate) and LFTs every 4 weeks for 3 cycles then at least every 8 weeks thereafter Blood pressure weekly for the first 4 weeks then every 4 - 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. 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 (December 2015) Page 1 of 6 Liver - Sorafenib Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Neutrophils (x109/L) 1 or greater Platelets (x109/L) and 50 or greater Dose Modifications 400mg twice a day 0.5 – 0.9 and 50 or greater 400mg once a day Delay until recovery to neutrophils 0.5x109/L or less than 0.5 or less than greater and platelets to 50x109/L or greater and 50 then reduce dose to 400mg once a day in the first instance Hepatic Impairment The SPC does not recommend dose modifications for patients with Child Pugh A or B hepatic impairment and states that there are no data for use in Child Pugh C hepatic impairment. The following are suggested starting doses from a pharmacokinetic study(2). If the patient tolerates the initial dose it may be escalated at the consultant’s discretion. Drug Sorafenib Bilirubin μmol/L less than 26 26 - 51 more than 51 Albumin g/L Less than 25 Dose 400mg twice a day 200mg twice a day Avoid* 200mg once a day Renal Impairment The SPC does not recommend any dose reductions for patients with renal impairment. The following are suggested starting doses based on a pharmacokinetic study(2). If the patient tolerates the initial dose it may be escalated at the consultant’s discretion. Drug Sorafenib Creatinine Clearance (ml/min) 40 or greater 20-39 less than 20 haemodialysis Dose 400mg twice a day 200mg twice a day Insufficient data 200mg daily Version 1.1 (December 2015) Page 2 of 6 Liver - Sorafenib 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 400mg once a day. Patients tolerating the re-introduction of sorafenib may be considered for a dose escalation back to 400mg twice a day. If there is further toxicity at a dose of 400mg once a day, delay treatment until resolution of the toxicity to NCI-CTC grade 1 or below. On reintroduction of the treatment, the dose should be further reduced to 400mg once a day on alternate days or 200mg once a day. Hypertension Sorafenib associated hypertension normally occurs early in treatment and is usually mild to moderate. Hypertension should be treated in accordance with current NICE guidelines. Raised blood pressure is not a reason to stop sorafenib unless it fails to respond to treatment or results in a hypertensive crisis. Skin NCI-CTC grade 2 or above palmar-plantar erythrodysaesthesia or rash may require a short break in treatment until it resolves to NCI-CTC grade 1 or below. The sorafenib can then be re-introduced at a dose of 400mg once a day and re-escalated as tolerated. Symptomatic measures such keeping the area well moisturised and cool, avoiding tight fitting socks, tights etc and avoiding activities that place pressure on the hands and feet may help. The patient should be advised to moisturise their hands and feet regularly and to keep them cool. 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 Dose Days Administration Sorafenib 400mg twice a day 1-28 inclusive Oral Dose Information Sorafenib is available as 200mg tablets. Administration Information It is recommended that sorafenib is taken on an empty stomach at least one hour before or two hours after a meal. Swallow whole with a full glass of water. Version 1.1 (December 2015) Page 3 of 6 Liver - Sorafenib Additional Therapy Emollients according to local trust policy Mouthwashes according to local or national policy on the treatment of mucositis Loperamide 4mg oral after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). Additional Information The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to sorafenib. Sorafenib has the potential to interact with many drugs, a thorough assessment of all concomitant medication is essential. Coding (OPCS) Procurement – X71.5 Delivery – X73.1 References 1. J Llovet, S Ricci, V Mazzaferro et al Sorafenib in Advanced Hepatocellular Carcinoma. NEJM 2008; 359 (4): 378-390 2. A Miller, D Murry, K Owzar et al; Phase I Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301. J Clin Oncol 2009; 27 (11): 1800 -1805 3. National Institute for Health and Clinical Excellence (2010). Hepatocellular carcinoma (advanced and metastatic) – sorafenib (first line). Technology Appraisal 189. London:DOH 4. SPC - Nexavar 200mg film-coated tablets, Bayer Plc,December 2014 Version 1.1 (December 2015) Page 4 of 6 Liver - Sorafenib REGIMEN SUMMARY Sorafenib Day One 1. Sorafenib 400mg twice a day oral Version 1.1 (December 2015) Page 5 of 6 Liver - Sorafenib DOCUMENT CONTROL Version Date Amendment Header changed Mucositis recommendation changed Neutrophil range changed from “0.5-1” to “0.5-0.9” in dose 1.1 Dec 2015 modification table Reference to grapefruit juice removed SPC reference updated Disclaimer added Spelling corrections and formatting changes 1 Dec 2012 None Written By Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Approved By Rebecca Wills Pharmacist Dr Joanna Gale Consultant Medical Oncologist Dr Mathew Wheater 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 1.1 (December 2015) Page 6 of 6 Liver - Sorafenib
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Hepatobiliary/Sorafenib-version-1.1.pdf
Alternatives to HRT for symptoms of the menopause - patient information
Description
This factsheet contains some non-hormonal alternatives and lifestyle changes you can try to help manage your menopausal symptoms.
Url
/Media/UHS-website-2019/Patientinformation/Womenshealth/Alternatives-to-HRT-for-symptoms-of-the-menopause-3081-PIL.pdf
Letrozole-Ribociclib
Description
Chemotherapy Protocol Breast Cancer Letrozole-Ribociclib Regimen • Breast Cancer – Letrozole-Ribociclib Indication • R
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Letrozole-Ribociclib.pdf
Letrozole-Palbociclib
Description
Chemotherapy Protocol Breast Cancer Letrozole-Palbociclib Regimen • Breast Cancer – Letrozole-Palbociclib Indication •
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Letrozole-Palbociclib.pdf
Exemestane-Ribociclib
Description
Chemotherapy Protocol Breast Cancer Exemestane-Ribociclib Regimen • Breast Cancer – Exemestane-Ribociclib Indication •
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Exemestane-Ribociclib.pdf
Exemestane-Palbociclib
Description
Chemotherapy Protocol Breast Cancer Exemestane-Palbociclib Regimen • Breast Cancer – Exemestane-Palbociclib Indication •
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Exemestane-Palbociclib.pdf
Everolimus-Exemestane
Description
Regimen Chemotherapy Protocol BREAST CANCER EVEROLIMUS and EXEMESTANE • Breast Cancer – Everolimus-Exemestane Indication • The first or
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Everolimus-Exemestane.pdf
Child protection and safeguarding - patient information
Description
Child protection and safeguarding Information for parents, carers and guardians Child protection at Southa
Url
/Media/UHS-website-2019/Patientinformation/Childhealth/Child-protection-and-safeguarding-2197-PIL.pdf
Pembrolizumab(400mg)
Description
Chemotherapy Protocol COLORECTAL CANCER Pembrolizumab (400mg) Regimen • Colorectal – Pembrolizumab (400mg) Indication • Pembrolizu
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Pembrolizumab400mg.pdf
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Last updated: 14 September 2019
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