Paclitaxel plus vinorelbine: An active regimen in metastatic breast cancerpatients with prior anthracycline exposure

Purpose: To evaluate the anti-tumour activity and tolerance of the combinat ion of paclitaxel plus vinorelbine in metastatic breast cancer (MBC) patien ts previously treated with anthracyclines. Patients and methods: Fifty-six MBC patients who have had at least one prev ious anthracycline-containing chemotherapy regimen were enrolled in this ph ase II trial. Patients received paclitaxel (135 mg/m(2) over one-hour infus ion) and vinorelbine (30 mg/m(2)) both on day 1 of each three-week course o f therapy (maximum eight courses or until disease progression was evident). Results: Six complete and nineteen partial responses were observed among th e fifty-four assessable patients (response rate of 46%, 95% CI: 33%-60%). R esponses were observed in all disease sites and in all subsets of patients. The response rates when paclitaxel plus vinorelbine were used as first, se cond and third-line chemotherapy for metastases were 67%, 41% and 35%, resp ectively. The response rate among anthracycline-refractory patients was 46% (6 of 13). Median time to progression in the overall patient group was 28 weeks. The main toxicities (CTC grade 2 or more) were alopecia, myelosuppre ssion and peripheral neuropathy (85%, 46% and 19% of patients, respectively ). Nine patients (17%) had neutropenic fever in fifteen of the three hundre d twenty-eight courses administered (5%). Conclusions: The combination of paclitaxel and vinorelbine on day 1 every t hree weeks is active in MBC patients with prior anthracycline exposure. The regimen is safe, well tolerated and convenient for the patients.