Cisplatin in the treatment of metastatic breast carcinoma. A prospective randomized trial of two dosage schedules

Thirty-seven patients with metastatic breast carcinoma were treated in a randomized study with cisplatin 60 mg/m² or 120 mg/m² I.V. q3 weeks. Most patients were heavily pretreated, having received an average of four prior cytotoxic agents. Partial responses were seen in 4/19 patients initially receiving cisplatin 120 mg/m² and 0/18 receiving 60 mg/m². One of the five patients responded when crossed over from cisplatin 60 mg/m² to cisplatin 120 mg/m². Average duration of response was 3 months and responses were seen in soft tissue and lung metastases. Toxicity in the form of nausea, vomiting, and inanition significantly limited the use of cisplatin in this patient population. We conclude that cisplatin is active in breast carcinoma and that a cisplatin at 120 mg/m² may be more effective than at 60 mg/m². However the study stopped short of statistical significance due to the toxicities of nausea, vomiting, and inanition.