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Regimen : Cisplatin and Capecitabine Indications Regimen details Administration • Palliative therapy for stage IV or relapsed squamous cell oesophageal cancer • 2 courses as induction therapy prior to surgery or definitive irradiation • Concomitant chemo-radiation for oesophageal cancer Day Drug Dose Route 2 1 Cisplatin 60mg/m IV infusion 2 PO 1-21 Capecitabine 625mg/m twice daily Pre hydration:1000 ml Sodium Chloride 0.9% over 60 minutes 200ml Mannitol 20% over 30 min OR 400ml Mannitol 10% over 30 min Cisplatin is administered in 500 ml Sodium Chloride 0.9% over 60 minutes Post Hydration: 1000 ml Sodium Chloride 0.9% + 20 mmol Potassium Chloride+ 8 mmol Magnesium Sulphate over 2 hours. An accurate fluid balance record should be kept. Advise patients to drink at least 2 litres or fluid over the next 24 hours. Cisplatin may interact with metal aluminium to form a black precipitate of platinum. All aluminium-containing IV sets, needles, catheters and syringes should be avoided. Capecitabine is available as 150mg and 500mg tablets (refer to dose calculations table). Tablets should be taken within 30 minutes after morning and evening meals. Dose level 625mg/m2 bd Body Surface Area (m2) Dose (mg) to be given twice daily 1.25 – 1.36 800 Frequency Extravasation Premedication Emetogenicity Additional recommended supportive medication Controlled document 1.37 – 1.52 1000 morning, 800 evening 1.53 – 1.66 1000 1.67– 1.78 1150 morning, 1000 evening 1.79– 1.90 1150 1.91 – 2.04 1500 morning, 1000 evening 2.05 – 2.16 1300 2.17 – 2.32 1500 morning, 1300 evening ≥2.33 1500 Every 21 days for up to 4 cycles Cisplatin is an exfoliant (Group 4) Capecitabine is an oral agent. Pre-hydration as above. This regimen has high emetogenic potential – refer to local protocol • • • Mouthwashes as per local policy. Loperamide 4mg po stat then 2mg prn if diarrhoea develops. Pyridoxine 50 mg tds reduces the severity of plantar-palmar erythrodyaesthesia (PPE). It should be given for any grade PPE and should be continued until the end of treatment. Document Number ASWCS11 GI006 Version Number 1.2.a Last printed 20/07/2012 10:54:00 * Only valid on day of printing Page 1 of 5 Pre-treatment evaluation Regular investigations Standard limits for administration to go ahead – if blood results not within range, authorisation to administer must be given by prescriber/consultant Dose modifications Haematological toxicity Renal impairment Hepatic impairment FBC U+E (incl SrCr) LFT Mg2+ and Ca2+ FBC U+E (incl SrCr) LFT Mg2+ and Ca2+ Neutrophil count Platelet count Creatinine clearance AST/ALP Bilirubin Defer therapy for 1 week if neutrophils <1.0 x 109/L or platelets < 100 x 109/L and then resume capecitabine and cisplatin at 75% dose CrCl (ml/min) Cisplatin Dose Capecitabine Dose >60 100% 100% 50-60 75% 100% 45-49 50% OR Substitute with 75% Carboplatin AUC 5 30-44 Substitute with Carboplatin 75% AUC 5 20-29 Substitute with Carboplatin Omit AUC 5 <20 Carboplatin contraindicated Omit AST +/- ALT ≤ 2.5 x ULN 2.5-5 x ULN >5 x ULN NCI Common toxicity criteria Toxicity Febrile neutropenia Diarrhoea (Capecitabine) Controlled document Baseline – results valid for 7 days Baseline – results valid for 7 days Baseline – results valid for 7 days Baseline – results valid for 7 days Results valid for 72 hrs Results valid for 7 days Results valid for 7 days Results valid for 7 days ≥1.0 x 109/L ≥100 x 109/L ≥60ml/min ≤1.5 x ULN ≤26micromol/L Document Number ASWCS11 GI006 Bilirubin Cisplatin dose 100% 100% Capecitabine dose ≤ 3.0 x ULN 100% > 3.0 x ULN Discuss with consultant. Current evidence suggests safe > 5 x ULN Omit Treatment unless secondary to biliary obstruction Definition Dose adjustment 9 ANC <0.5 x 10 /L plus Delay until FBC recovers fever requiring IV then reduce both cisplatin antibiotics +/and capecitabine to 50% hospitalisation dose Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output Version Number 1.2.a Last printed 20/07/2012 10:54:00 * Only valid on day of printing Delay until ≤ Grade 1 then resume at 100% Page 2 of 5 Palmar-Plantar Erythrodyaesthesia (Hand-Foot Syndrome) (Capecitabine) compared to baseline Grade 3/4: Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline Grade 1: Minimal skin changes or dermatitis (e.g., erythema, edema, or hyperkeratosis) Discomfort but no pain; no interruption of ADL Grade 2: Skin changes (e.g., peeling, blisters, bleeding, edema, or hyperkeratosis) Pain; limiting instrumental ADL Grade 3: Severe skin changes (e.g.,peeling, blisters, bleeding, edema, or hyperkeratosis) Pain; limiting self care ADL Controlled document Neurotoxicity/ Ototoxocity (Cisplatin) ≥Grade 2 Neuropathy or Ototoxicity Stomatitis Grade 1: painless ulcers, erythema, mild soreness Grade 2: painful erythema, edema, or ulcers but can eat or swallow Grade 3: painful erythema, edema, or ulcers requiring IV hydration, and cannot eat Grade 4: severe ulceration or requires parenteral or enteral nutritional support or prophylactic intubation. Document Number ASWCS11 GI006 Version Number 1.2.a Last printed 20/07/2012 10:54:00 * Only valid on day of printing Delay until ≤ Grade 1 then resume at 75% Treat symptomatically and maintain doses at 100% 1st appearance: delay until ≤ Grade 1 then resume capecitabine at 75% (cisplatin at 100%) 2nd appearance: delay until ≤ Grade 1 then resume capecitabine at 50% (cisplatin at 100%) 3rd appearance: discontinue permanently 1st appearance: delay until ≤ Grade 1 then resume capecitabine at 50% (cisplatin at 100%) 2nd appearance: discontinue or delay until ≤ Grade 1 then resume capecitabine at 50% (cisplatin at 100%) Cisplatin should be permanently stopped and replaced with carboplatin AUC5. 100% Omit until toxicity ≤ Grade 1, then resume cisplatin and capecitabine at 75% Omit until toxicity ≤ Grade 1, then resume cisplatin and capecitabine at 50% Discontinue OR Omit until toxicity ≤ Grade 1, then resume cisplatin and capecitabine at 50% Page 3 of 5 Adverse effects – Rare but serious side effects Frequently occurring side effects the contents of the table indicate the adverse effects that should be documented on consent to treatment forms Febrile neutropenia Palmar-plantar erythrodyaesthesia (PPE) / Hand-foot syndrome (HFS) Stomatitis and mucositis Nausea/vomiting Fatigue / asthenia Myelosuppression Thrombosis/embolism Cardiac toxicity including arrhythmias or ischaemia Ocular Toxicity Other Significant drug interactions – For full details consult product literature/reference texts Diarrhoea Ototoxicity Neurotoxicity Skin reactions, nail changes, taste disturbances Coumarin-derived anticoagulants such as warfarin – patients established on warfarin should either be changed to low molecular weight heparin or have weekly monitoring of INR. Patients who are initiated on anti-coagulation should remain on low molecular weight heparin until completion of the course of capecitabine-cisplatin. Allopurinol and antigout agents: interactions have been observed between allopurinol and fluorouracil with possible decreased efficacy of fluorouracil. Concomitant use of allopurinol with capecitabine should be avoided. Cisplatin may increase the concentration of blood uric acid. Thus, in patients concurrently receiving antigout agents such as allopurinol, colchicine, probenecid or sulfinpyrazone, dosage adjustment of these drugs may be necessary to control hyperuricemia and gout. Phenytoin and fosphenytoin: close monitoring and/or alternative agents are recommended if co-prescribed with any of these agents. Phenytoin serum levels may be decreased, possibly as a result of decreased absorption and/or increased metabolism. Capecitabine: Sorivudine and its analogues – co-administration causes increased fluoropyrimidine toxicity which may be fatal Folinates Avoid concomitant use of folinic and folic acid – enhanced toxicity of capecitabine Antacids – the use of antacids with capecitabine can decrease absorption – avoid. Comments Cumulative Doses References Controlled document Cisplatin: Concurrent and/or sequential administration of ototoxic or nephrotoxic drugs such as aminoglycoside antibiotics, loop diuretics and amphotericin B may increase the occurrence of these toxicities, especially in the presence of renal impairment. Dihydropyrimidine dehydrogenase (DPD) deficiency can result in severe toxicity secondary to reduced fluorouracil metabolism – avoid use in patients with known DPD deficiency Cardiotoxicity has been associated with fluoropyrimidine therapy, with adverse events being more common in patients with a prior history of coronary artery disease. Caution must be taken in patients with a history of significant cardiac disease, arrhythmias or angina pectoris. N/A • Lee SS, Kim S-B, Park S-I, Kim YH, Ryu J-S. Song H-Y, et al. Capecitabine and Cisplatin Chemotherapy (XP) Alone or Document Number ASWCS11 GI006 Version Number 1.2.a Last printed 20/07/2012 10:54:00 * Only valid on day of printing Page 4 of 5 • • • • • • • • Document title Document number Approval date Written by Checked by Authorised by Review date Document reviewed by Version number Summary of changes Controlled document Sequentially Combined Chemoradiotherapy Containing XP Regimen in Patients with Three Different Settings of Stage IV Esophageal Cancer. Jpn J Clin Oncol 2007; 37 (11): 829-835. Lee J, Im YH, Cho EY, Hong YS, Lee HR, Kim HS, et al. A phase II study of capecitabine and cisplatin (XP) as first-line chemotherapy in patients with advanced esophageal squamous cell carcinoma. Cancer Chemother Pharmacol 2008; 62 (1): 77-84. please confirm if these two references are (a) appropriate and (b) sufficient NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [internet] accessed 04/02/2011 available at http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-0614_QuickReference_5x7.pdf Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in hepatic impairment [internet]. accessed 04/02/2011 available at http://www.bopawebsite.org/tikidownload_file.php?fileId=621 Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in renal impairment [internet]. accessed 04/02/2011 available at http://www.bopawebsite.org/tikidownload_file.php?fileId=620 Summary of Product Characteristics Xeloda® (Capecitabine) 500mg and 150mg Tablets (Roche) [internet], accessed 04/02/2011 available from http://www.medicines.org.uk/EMC/medicine/4619/SPC/Xeloda/ Summary of Product Characteristics Cisplatin 1mg/ml sterile concentrate (Hospira) [internet].accessed 04/02/2011 available from http://www.medicines.org.uk/EMC/medicine/623/SPC Baxter K, editor. Stockley’s Drug Interactions. Pharmaceutical Press; 2009. Accessed on line on 04/02/2011 available at https://www.medicinescomplete.com/mc/ Allwood M, Stanley A, Wright P, editors. The cytotoxics handbook. 4th ed. Radcliffe Medical Press. 2002. Cisplatin and Capecitabine ASWCS11 GI006 19/07/2011 Stephen Falk, Consultant Clinical Oncologist BHOC James Carr, Network Pharmacist, ASWCS Jeremy Braybrooke, Chair ASWCS Drugs and Therapeutics Committee 19/07/2013 Version Steve Falk James Carr Jeremy Braybrooke Digitally signed by Steve Falk DN: cn=Steve Falk, o, ou, email=james. [email protected], c=GB Date: 2012.07.20 10:55:42 +01'00' Digitally signed by James Carr DN: cn=James Carr, o=ASWCS, ou=Network Pharmacist, [email protected], c=GB Date: 2012.07.20 10:56:10 +01'00' Digitally signed by Jeremy Braybrooke DN: cn=Jeremy Braybrooke, o, ou, [email protected], c=GB Date: 2012.07.20 10:56:41 +01'00' 1.2.a: amended July 2012 to include the option of Mannitol 10% Document Number ASWCS11 GI006 Version Number 1.2.a Last printed 20/07/2012 10:54:00 * Only valid on day of printing Page 5 of 5