Vinorelbine (Navelbine ) plus Capecitabine (Xeloda ) Cumbria, Northumberland, Tyne & Wear Area Team

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1 DRUG ADMINISTRATION SCHEDULE Day Drug Daily Dose Route Diluent Rate Day 1 Vinorelbine 60 to 80 mg/m 2 Oral N/A Stat Dose Days 1 to 14 Capecitabine 1000 mg/m 2 twice a day* Vinorelbine Capecitabine protocolcrp11b0024 v1.1 Page 1 of 5 Oral N/A 14 days on 7 days off Day 8 Vinorelbine 60 to 80 mg/m 2 Oral N/A Stat Dose DOSE FORM Capecitabine is supplied as 150mg and 500mg tablets, therefore calculated s must be rounded to the nearest 150mg. Vinorelbine supplied as 20mg, 30mg or 80mg capsules. CYCLE LENGTH AND NUMBER OF DAYS 21 days, until disease progression Oral capecitabine given from day 1 to 14, twice daily, then 1 week off Vinorelbine given as single on day 1 & day 8, start at 60 mg/m² for first cycle then assess patient and escalate to 80 mg/m² as per protocol. APPROVED INDICATION For first line metastatic breast cancer if previously had taxane and Her 2 negative (specifically young, short disease free interval, visceral metastases, rapid progression of disease). ELIGIABILITY CRITERIA Breast cancer patients with adequate renal and cardiac function. EXCLUSION CRITERIA - Patients incapable of managing oral chemotherapy themselves or with the assistance of a carer - Patients with swallowing difficulties - Significant cardiac risk factors for development of CHF PREMEDICATION As above RECOMMENDED TAKE HOME MEDICATION Metoclopramide 10 mg three times daily as required Ondansetron 8mg twice daily for 1 day on day 1 and 8 (with vinorelbine) INVESTIGATIONS / MONITORING REQUIRED Pre treatment: Assessment of renal and hepatic function, FBC, and cardiac history. Prior to each cycle FBC, U&E, LFT s & tumour markers as appropriate Where CEA is elevated this should be measured before each cycle.

2 ASSESSMENT OF RESPONSE Metastatic: Tumour size and patient symptomatic response REVIEW BY CLINICIAN To be reviewed by a nurse, a pharmacist or a clinician before every cycle. NURSE / PHARMACIST LED REVIEW On cycles where not seen by clinician. ADMINISTRATION NOTES COUNSELLING POINTS FOR ORAL VINORELBINE AND CAPECITABINE How to take: Capecitabine: Take tablets 12 hours apart, within 30 minutes after the end of meal (i.e. breakfast & evening meal.) Swallow whole with water Vinorelbine: Taken either at least one hour before, or at least one hour after food. Side effects Common side effects to discuss with patient include; diarrhoea, nausea & vomiting, rash, hand-foot syndrome (painful red swelling in hands and feet), fatigue, muscle pain, fever or infection. If patients notice any of these, advise them to stop taking treatment and contact chemotherapy day unit. The liquid content of vinorelbine capsules is an irritant, if capsule contents touch skin, mouth or eyes, rinse affected area with water or preferably a normal saline solution. Missed : Capecitabine: If remember half an hour after that they should have taken their tablets, then take the missed, otherwise only take the regular at next scheduled time. Do NOT double-up s to make up for the missed s or take extra s at the end of the treatment cycle. Vinorelbine: If the scheduled days dosing is missed, advise patient to not to take and contact their named chemotherapy contact Post vomiting: In the case of vomiting within a few hours after drug intake, never repeat the administration of the. Storage/ Disposal Capecitabine tablets stored in cool dry place less than 30 C. Vinorelbine Capsules should be refrigerated between 2-8 C Safe handling: The liquid content of the vinorelbine capsules is an irritant and may cause damage if comes into contact with skin, mucosa or eyes. If capsule is chewed or sucked in error or is cut or damaged and contents touch skin, mouth or eyes, rinse affected area with water or preferably a normal saline solution. Vinorelbine Oral has been demonstrated to bioequivalent to IV at s tested: Vinorelbine IV 25 mg/m 2 is equivalent to Vinorelbine oral 60 mg/m 2 Vinorelbine IV 30 mg/m 2 is equivalent to Vinorelbine oral 80 mg/m 2 Vinorelbine Capecitabine protocolcrp11b0024 v1.1 Page 2 of 5

3 Food does not affect absorption of vinorelbine but it is advised to take with food to reduce gastro-intestinal upset. Advise patients of the risk of hand-and-foot skin-reaction (palmar/plantar erythrodysesthesia) and that they should stop taking treatment and contact their chemotherapy unit if they have pain, swelling, and redness of hands and/or feet. Diarrhoea is common, and may require intervention with fluids and electrolytes if severe. If diarrhoea is a problem give loperamide 2 to 4 mg four times daily as required or codeine phosphate 30mg four times daily (see below) EXTRAVASATION Not applicable, oral therapy. TOXICITIES Rash Nausea and Vomiting Diarrhoea Constipation Palmar/Plantar Erythrodysesthesia - Can be severe, patients must be forewarned Fatigue Stomatitis Cardiotoxicity Peripheral Neuropathy Fatigue, Myalgia Myelosuppression (Neutropenia common) DOSE MODIFICATION / TREATMENT DELAYS Haematological Toxicity: ANC < 1 to1.5 and/or platelets <100, delay for 1 week >1 week recovery, reduce capecitabine by 25% Day One: Proceed if neutrophil count > 1.5, WBC > 3.0, plts >100, unless directed by an Oncology specialist. Delay 1 week on DAY 1 if:- WCC PLT ANC < 3.0 <100 < 1.5 Day Eight Proceed on if neutrophil count > 1.0, plts >100, unless directed by an Oncology specialist. Omit treatment On DAY 8/15 if:- PLT < 100 ANC < 1.0 NB On Day 8 of the cycle patients whose bloods are not at the required level will miss that and proceed to the next cycle of treatment as planned Vinorelbine Capecitabine protocolcrp11b0024 v1.1 Page 3 of 5

4 Non-Haematological Toxicity Table of capecitabine adjustments according to CTC toxicity (non-haematological and not PPE/hand/foot) Grade 2 Grade3 Grade 4 1 st appearance continue at 100% of original with prophylaxis where possible 2 nd appearance 3 rd appearance continue at 75% of original continue at 50% of original 4 th appearance Discontinue treatment continue at 75% of original with prophylaxis where possible resolved to grade0/1, then continue at 50% of original Discontinue treatment Discontinue treatment Table of Diarrhoea toxicity grading for capecitabine only CTC Toxicity % 5FU Grade 1 Diarrhoea (watery stool 2-3 times/day) Hold until recovery, then resume at 100% for remainder of course 2 Diarrhoea (watery stool 4-6 times/day) Hold until recovery, then resume at 75% for remainder of course 3/4 Diarrhoea (watery stool >7 times/day Following grade 3 or 4 diarrhoea, subsequent s of capecitabine should be decreased or treatment discontinued permanently (grade 4). *see manufacturer s datasheets for full details Renal Function Capecitabine is renally excreted; therefore requires adjustment for patients with moderate renal impairment (<50ml-30ml/min) require a 25% reduction. Contra-indicated in severe renal failure (CrCl <30ml/min) (Cockroft & Gault) TREATMENT LOCATION Can be given at Cancer Centre or Cancer Unit Vinorelbine Capecitabine protocolcrp11b0024 v1.1 Page 4 of 5

5 REFERENCES: Campone M et al. Eur J Cancer Suppl 2009; 7 (2): 259, abs O-5000 Finek J et al. Anticancer Res 2009; 29: Jones A et al. Cancer Chemother Pharmacol 2010; 65: NICE clinical guideline 81, February 2009: Sawada N et al. Proc Am Assoc Cancer Res 2002; 43: 1088, Abs 5388 Tubiana-Mathieu N et al. Br J Cancer 2009; 101: Document Control Document Title: Vinorelbine & Capecitabine NECN protocol CRP11 B0024 Document No: Author: Approved by: CRP11 B0024 Due for Review: 29 May 2016 Summary of Changes Steve Williamson, Consultant Pharmacist Dr. Eleanor Aynsley South Tees NHS Trust Current 1.1 Version: Approval Signature* Date 29/05/2014 Approved: 1.1 Protocol reviewed and reissued, Antiemetic advice updated Vinorelbine Capecitabine protocolcrp11b0024 v1.1 Page 5 of 5