The aims of this study were to determine the efficacy of docetaxel (DOC) 60 mg/m2 and cisplatin (CDDP) 80 mg/m2 combined chemotherapy in Japanese patients with anthracycline-pretreated advanced breast cancer, and to report the side effects of this therapy. Fourteen patients with anthracycline-pretreated advanced breast cancer were enrolled. DOC was administered at 60 mg/m2 intravenously over at least 1 h, and then CDDP was administered at 80 mg/m2 intravenously over at least 3 h. Two courses of this regimen were administered at an interval of 3-4 weeks. Two more courses were administered after 6 months if the disease did not progress, or toxicity was acceptable. The overall response (OR) rate was 64.3%. In the patients with metastases, OR was 58.3%, median duration of the response was 31 weeks (range, 6 to 78 weeks), and median overall survival was 85 weeks (range, 35 to >159). Grade 3/4 toxicities were: neutropenia 10/14; anorexia 5/14; nausea/vomiting 3/14; diarrhea 4/14; oral symptoms 1/14. In conclusion, the combination of DOC (60 mg/m2) and CDDP (80 mg/m2) is an active regimen that can be relatively safely administered to Japanese patients with anthracycline-pretreated advanced breast cancer.

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