PHASE-II STUDY OF CARBOPLATIN AND ETOPOSIDE AS A FIRST-LINE REGIMEN IN PATIENTS WITH METASTATIC BREAST-CANCER

Background: The data available on the role of carboplatin and etoposide in breast cancer, especially in patients with no or minimal prior therapy are limited. Patients and methods: We performed a phase II study with carboplatin and etoposide as first line treatment in 34 patients with metastatic breast cancer. The treatment regimens was carboplatin 300 mg/m(2) day 1, and etoposide 100 mg/m(2) days 1, 3 and 5, every four weeks. Results: Of 33 evaluable patients, 2 achieved complete responses (6%) lasting 4 and 5 months, 7 patients (21%) achieved partial responses with a median duration of 6+ (range 5-8) months, 15 patients had stable disease, and 9 progressed during treatment. The major toxicity was myelosuppression. WHO grades 3 or 4 leukocytopenia or thrombocytopenia were seen in 15 and 10 patients, respectively. One formally ineligible patient with an impaired renal function died 14 days after the start of treatment because of a septicaemia in the presence of a grade 4 leukocytopenia. Besides this patient no other patient presented with granulocytopenic fever. Conclusion: In view of the observed response rate of 27% (95% confidence interval 11%-43%) we think that carboplatin and etoposide given in this dose and schedule has probably no clear advantage over the more commonly used regimens.