Gemcitabine plus cisplatin repeating doublet therapy in previously treated, relapsed breast cancer patients

Purpose: To determine the safety and efficacy of gemcitabine plus cisplatin for patients with relapsed adenocarcinoma of the breast. Patients and Methods: Previously treated patients with adenocarcinoma of th e breast received cisplatin (30 mg/m(2)) plus gemcitabine (1,000 mg/m(2)) o n days 1, 8, and 15 of each 28-day cycle, which was changed after patient n o. 12 to cisplatin (30 mg/m(2)) plus gemcitabine (750 mg/m(2)) days 1 and 8 of each 21-day cycle. Results: Of 30 patients, three (10%) had complete and 12 (40%) had partial responses, for an overall response rate of 50%. Two objective responses wer e observed among the four patients accrued after relapse that followed high -dose/stem-cell therapies, The median time to progression was 14 weeks. The median time to progression for objective responders was 23.5 weeks, with a range of 8 to 68 weeks. Toxicities included grades III and IV neutropenia in 13%, anemia in 6%, thrombocytopenia in 31%, grade III nausea in 4%, and grade II peripheral neuropathy in 2% of 151 treatment cycles. Moderate alop ecia occurred in four patients. There were no treatment-related deaths. Conclusion: Cisplatin plus gemcitabine is active and tolerable for patients with relapsed breast cancer. Responses observed in previously treated pati ents, including high-dose/stem-cell failures, indicate activity in otherwis e drug-refractory patients. J Clin Oncol 18:2245-2249, (C) 2000 by American Society of Clinical Oncology.