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

Background: Single-agent bi-weekly paclitaxel was studied as first-line met astatic 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 neuro toxicity (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 1 50 mg/m(2) and three CRs and 11 PRs for an overall RR of 67% for the two to p doses. Conclusions. The good drug tolerance, response rates, and convenience over weekly treatment suggest this may be a worthwhile regimen.