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Yamamoto N.,Chiba Cancer Center | Yamamoto N.,Japan East Cancer Center Breast Cancer Consortium | Tabei T.,Japan East Cancer Center Breast Cancer Consortium | Inoue K.,Japan East Cancer Center Breast Cancer Consortium | And 7 more authors.
Japanese Journal of Cancer and Chemotherapy

A recent foreign clinical trial showed that the combination of docetaxel plus cyclophosphamide (TC) is associated with a superior disease-free survival compared with doxorubicin plus cyclophosphamide as adjuvant chemotherapy for breast cancer. To assess the tolerability and safety of TC in a Japanese patient population, we conducted a multicenter, open-labeled clinical trial. Eligible patients were women who had axillary lymph node-negative breast cancer with surgical excision of the primary tumor. Patients were treated with 4 courses of TC (75 and 600 mg/m2, respectively), administered intravenously every 3 weeks. The primary endpoint was feasibility, which was defined as the proportion of patients who completed 4 courses of the chemotherapy. From October 2006 to November 2007, 39 patients were enrolled and 32 were evaluable. Seven patients were excluded because of the inadequate treatment schedule. Feasibility was 96.9% (31/32). One patient did not complete treatment because of the hypersensitivity. The mean administered dose was 73.2 mg/m2 for docetaxel and 588.3 mg/m2 for cyclophosphamide, respectively. The mean relative dose intensity was 96.1% and 95.7%, respectively. The grade 3/4 toxicity including leukopenia, neutropenia, and febrile neutropenia was manageable. From these results, we consider that TC might become a standard non-anthracycline adjuvant regimen for operable breast cancer. Source

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