Phase I/II trial of biweekly paclitaxel and cisplatin in the treatment of metastatic breast cancer.

• DOI: 10.1200/jco.1996.14.4.1185
• Publication Date: 2017-02-24T09:46:12Z
• Authors: K A Gelmon; S E O'Reilly; A W Tolcher; C Campbell; C Bryce; J Ragaz; C Coppin; I H Plenderleith; D Ayers; B McDermott; L Nakashima; D Healey; N Onetto
• Keywords: Adult; Paclitaxel; Breast Neoplasms; Middle Aged; Antineoplastic Agents, Phytogenic; Drug Administration Schedule; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Antineoplastic Combined Chemotherapy Protocols; Feasibility Studies; Humans; Female; Cisplatin; Aged

PURPOSE To determine the maximum-tolerated dose of escalating doses paclitaxel (Taxol; Bristol-Myers Squibb, Princeton, NJ) administered biweekly with a fixed cisplatin, to assess toxicity, and evaluate activity this combination in phase I/II trial metastatic breast cancer. PATIENTS AND METHODS Twenty-nine women cancer were enrolled; 27 assessable for response 29 toxicity. All but two had received prior adjuvant chemotherapy, 23 receiving anthracyclines six previous cisplatin. RESULTS The initial starting paclitxel 90 mg/m2 cisplatin 60 became II due dose-limiting neutropenia. Responses seen 85% patients, three patients (11%) achieving complete (CR) 20 (14%) partial (PR), an overall rate (95% confidence interval [CI], 66% 96%). time disease progression who achieved CR was 110 200 days, those PR, it 96 377+ median 7.1 months duration 7.9 months. Sites skin, soft tissue, lung, all occurred exposure anthracyclines. Septic events rare, grade 3 infections (7%), only one which required hospital admission. There no 4 nonhematologic toxicity minimal A total 251 chemotherapy cycles given -- 16 alone five patients. Forty-five percent reductions, while 52% delays CONCLUSION Biweekly is active treatment cancer, including