A phase I–II study of bi-weekly paclitaxel as first-line treatment in metastatic breast cancer

Summary Background: Single-agent bi-weekly paclitaxel was studied as first-line metastatic treatment for breast cancer in a phase I—II trial. Patients and methods: Thirty-eight women with metastatic breast cancer were enrolled. Thirty-seven are evaluable for toxicity, 35 for response. Results: The MTD was defined at 160 mg/m 2 q two weeks with dose limiting toxicity in two patients consisting of hematological toxicity (1) and neurotoxicity (2). Twenty patients were treated at 150 mg/m 2 , the recommended dose. Response rates were two CRs and nine PRs (overall 61%) at the RD of 150 mg/m 2 and three CRs and 11 PRs for an overall RR of 67% for the two top doses. Conclusions: The good drug tolerance, response rates, and convenience over weekly treatment suggest this may be a worthwhile regimen.