Docetaxel + Carboplatin + Trastuzumab (TCH) Adjuvant Breast Cancer

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1 Docetaxel + Carboplatin + Trastuzumab (TCH) Adjuvant Breast Cancer Background: A non-anthracycline based regimen for high-risk, HER 2 positive breast cancer in the adjuvant setting (BCIRG 006). Patient Group: Adjuvant treatment of high-risk breast cancer (node negative or positive) and HER2 positive PS 0-1 Pre-treatment Assessment: Weight, FBC, U&E, LFTs and Creatinine clearance LVEF and cardiac assessment Treatment Threshold WBC 3.0 x 10 9 /L ANC 1.0 x 10 9 /L Platelets 100 x10 9 /L Regimen Details: Day 1 Cycle 1 Trastuzumab 8mg/kg In 250 sodium chloride IV infusion over 90 minutes Docetaxel 75mg/m ml sodium chloride infusion over 60 minutes Carboplatin AUC 6 in 500ml glucose 5% IV infusion over 60 minutes Day 1 Cycle 2-6 Trastuzumab 6mg/kg In 250 sodium chloride IV infusion over 90 minutes Docetaxel 75mg/m ml sodium chloride infusion over 60 minutes Carboplatin AUC 6 in 500ml glucose 5% IV infusion over 60 minutes Day 1 Cycle 7-18 Trastuzumab 6mg/kg In 250 sodium chloride IV infusion over 90 minutes Cycles repeated every 21 days Page1

2 Administration: Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions. Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available. If hypersensitivity reactions occur, minor symptoms such as flushing or localized cutaneous reactions do not require interruption of therapy. However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy. Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel. The initial dose of Trastuzumab should be administered over 90 minutes. Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms.interruption or slowing the rate of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate. If the initial loading dose of trastuzumab is well tolerated, the subsequent doses can be administered as a 30-minute infusion. Pre-Meds: Dexamethasone 8mg PO BD for 3 days starting the day before chemotherapy. Ondansetron 8-16mg IV 30 minutes prior to chemotherapy. Anti-emetics: Ondansetron PO 8mg BD for two doses, Domperidone PO 20mg QDS 3-5 days then PRN Additional Medication: Cycles 1-6 only: Filgrastim 30MU or 48 MU S/C daily for 7 days starting day 3. (<70kg Filgrastim 30 MU, >70kg Filgrastim 48MU). Monitoring and Assessment: Clinical Assessment FBC prior to each cycle U&E, LFT creatinine clearance (calculated) prior to each cycle LVEF as per North Wales guidelines Page2

3 Dose Modifications: Haematological toxicity Neutrophils < 1.0 x 10 9 /L defer dose Platelets < 100 x 10 9 /L defer dose If febrile neutropenia, neutrophil < 500cells/mm 3 for more than one week then give Docetaxel 60mg/m 2 and Carboplatin at AUC 5 dose. Trastuzumab dose should remain at 100%. Non Haematological Toxicity (Excluding Alopecia) For toxicities of up to grade 2- delay treatment by one or more weeks until recovery to grade 0 or 1. For severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 75 to 60mg/m 2. (Carboplatin dose should remain at 100%). For other grade 3 or 4 non-haematological toxicities docetaxel should be reduced from 75 to 60mg/m 2 and Carboplatin dose reduced to AUC 5. Trastuzumab dose should remain at 100%. If the patient continues to experience these reactions the treatment should be discontinued Renal Impairment Carboplatin: Adjust dose using Calvert formula. Dose = AUC (25 + GFR) Contra indicated if creatinine clearance is < 20ml/min. Hepatic Impairment Docetaxel at 100mg/m 2 as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 60 mg/m 2.For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated. Pharmaceutical Care: If a dose greater than 185mg of docetaxel (192 mg if not withdrawing equivalent amount of infusion fluid) is required, use a larger volume of the infusion vehicle so that a concentration of 0.74mg/ml docetaxel is not exceeded. Page3

4 If the patient misses a dose of Trastuzumab by more than one week, a re-loading dose of Herceptin should be given over approximately 90 minutes (three-weekly regimen: 8 mg/kg). Subsequent Herceptin maintenance doses (three-weekly regimen 6 mg/kg respectively) should then be given (three-weekly regimen every 3 weeks) from that point. Clinically significant interactions with docetaxel which induce, inhibit or are metabolised by cytochrome P450-3A, include: ciclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin. Concurrent therapy with nephrotoxic drugs or ototoxic drugs such as amino glycoside, vancomycin, and diuretics is not recommended, since this may lead to increased or exacerbated toxicity due to carboplatin induced changes in renal clearance of these substances. A decrease in phenytoin serum levels has been observed in case of concurrent administration of carboplatin and phenytoin. This may lead to reappearance of seizure and may require an increase of phenytoin dosages. Most Common Toxicities: Nausea & Vomiting Alopecia Neutropenia +/- infection Fatigue Sensory neuropathy Skin reaction (May be severe) Oedema Mucositis Diarrhoea Fever Nail disorder Abnormal Electrolytes Nephrotoxicity Thrombocytopenia LFTs serum electrolytes (sodium, magnesium, potassium and calcium) Hypersensitivity (May be severe) Myalgia & Arthralgia Motor neuropathy Page4

5 References: 1. SPC Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion. Actavis UK Ltd. [accessed 20 th September 2011] 2. SPC Herceptin Roche Products Limited. [accessed 20 th September 2011] 3. SPC Carboplatin 10mg/mL concentrate solution for infusion. Sun Pharmaceuticals UK Ltd [accessed 20 th September 2011] 4. Slamon D, Eiermann W, Robert N., et al. BCIRG 006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her2neu positive early breast cancer patients (Abstract). San Antonio Breast Cancer Symposium, December 14, North London Cancer Network guidelines for dosage adjustment for cytotoxics in renal and hepatic impairment. NLCN Page5

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