Phase II study of cisplatin and 5-fluorouracil in previously treated metastatic breast cancer: an Eastern Cooperative Oncology Group study (PA 185)

Purpose: The present study was conducted to investigate the efficacy and toxicity of a cisplatin and 5-fluorouracil (5-FU) combination in previously treated advanced breast cancer. Methods: Thirty-six women with recurrent metastatic breast cancer were entered on a phase II study of 5-FU 1000 mg/m(2)/day given intravenously as a continuous infusion on days 1-3 and cisplatin 30 mg/m(2)/day given intravenously over 1 h on days 2-4, repeated every 21 days. All subjects had received one previous chemotherapy regimen for metastatic disease and either progressed during treatment or relapsed after responding to previous chemotherapy. Fourteen patients had also received previous adjuvant chemotherapy, 17 patients had previous radiation therapy, and 29 patients had previous hormonal therapy. Results: Among 32 response-evaluable patients, there were 10 partial remissions (31%) and 1 complete remission (3%), with an overall objective response rate of 34%. Median duration of response was 4 months. Median survival was 10.5 months for responders and 9.5 months for the entire group. Toxicity was mild to moderate in most patients. Overall twelve patients experienced grade 3 toxicity (10 hematologic, 1 mucositis, and 2 nausea). There were no grade 4 or 5 toxicities. Conclusion: Infusional cisplatin and 5-FU is a well tolerated and active regimen in women with previously treated advanced breast cancer.