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ATC codes: L01XA01
EMLc
Indication
Unspecified malignant neoplasms of ill-defined or unspecified sites ICD11 code: 2D9Z
INN
Cisplatin
Medicine type
Chemical agent
List type
Complementary (EML)
(EMLc)
Formulations
Parenteral > General injections > unspecified: 10 mg in vial powder for injection ; 50 mg in vial powder for injection
EML status history
First added in 1984 (TRS 722)
Changed in 2002 (TRS 914)
Changed in 2007 (TRS 950)
Removed in 2009 (TRS 958)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Tags
Wikipedia
DrugBank
Summary of evidence and Expert Committee recommendations
Cisplatin was replaced by carboplatin on the complementary list of the EML and EMLc. The Committee noted that the application included supportive evidence for the effectiveness and safety of carboplatin from systematic reviews (1-3) and RCTs (4-6). The Committee noted that the most recent meta-analysis came from a Cochrane Review (3), which showed that carboplatin was no more or less effective than cisplatin in any particular subgroup of women with advanced ovarian cancer. The Committee noted that the toxicity profiles of carboplatin and cisplatin are different, with carboplatin being better tolerated overall than cisplatin. The major dose-limiting adverse effects associated with carboplatin are thrombocytopaenia and leukopaenia; those associated with cisplatin are nephrotoxicity, ototoxicity, neurotoxicity and emesis. The Committee noted that the evidence presented in the application indicated that carboplatin was more cost-effective than cisplatin. Overall, the evidence provided in the application supports the public health need, comparable effectiveness and generally more favourable tolerability of carboplatin than cisplatin. The Committee therefore recommended that carboplatin replace cisplatin on the Complementary Model List (with a square box) for the treatment of advanced ovarian cancer. References: 1. Advanced Ovarian Cancer Trialists Group. Chemotherapy in advanced ovarian cancer: an overview of randomised clinical trials. British Medical Journal, 1991, 303:884–893. 2. Aabo K et al. Chemotherapy in advanced ovarian cancer: four systematic meta-analyses of individual patient data from 37 randomized trials. Advanced Ovarian Cancer Trialists’ Group. British Journal of Cancer, 1998, 78:1479–1487. 3. Advanced Ovarian Cancer Trialists Group. Chemotherapy for advanced ovarian cancer. Cochrane Database of Systematic Reviews, 1999, Issue 1. DOI: 101002/14651858CD001418. 4. Ozols RF et al. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group Study. Journal of Clinical Oncology, 2003, 21:3194–3200. 5. du Bois A et al. A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. Journal of the National Cancer Institute, 2003, 95:1320–1330. 6. ICON Collaborators. ICON2: randomised trial of single-agent carboplatin against three drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer. International Collaborative Ovarian Neoplasm Study. Lancet, 1998, 352: 1571–1576.