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 to xicity of a cisplatin and 5-fluorouracil (5-FU) combination in previously t reated advanced breast cancer. Methods: Thirty-six women with recurrent metastatic breast cancer were ente red on a phase II study of 5-FU 1000 mg/m(2)/day given intravenously as a c ontinuous infusion on days 1-3 and cisplatin 30 mg/m(2)/day given intraveno usly over 1 h on days 2-4, repeated every 21 days. All subjects had receive d one previous chemotherapy regimen for metastatic disease and either progr essed during treatment or relapsed after responding to previous chemotherap y. Fourteen patients had also received previous adjuvant chemotherapy, 17 p atients had previous radiation therapy, and 29 patients had previous hormon al therapy. Results: Among 32 response-evaluable patients, there were 10 partial remiss ions (31%) and 1 complete remission (3%), with an overall objective respons e rate of 34%. Median duration of response was 4 months. Median survival wa s 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 re gimen in women with previously treated advanced breast cancer.