Paclitaxel plus vinorelbine in metastatic breast Ca patients with contraindications to receive anthracyclines.

Thirty-three metastatic breast cancer patients with prior chemotherapy (adjuvant alone, 9 patients; chemotherapy for metastatic disease alone, 13 patients; chemotherapy for both, 11 patients) received paclitaxel (Taxol) 135 mg/m2 over 1 h followed by vinorelbine (Navelbine) 30 mg/m2 over 10 minutes on day 1 every 3 weeks. All patients had contraindications to receive anthracycline therapy (primary resistance, 10 patients; dose reaching the maximum recommended dose and/or myocardiopathy, 23 patients). Twenty-eight patients had previously received anthracyclines, and the remaining 5 had received prior CMF (cyclophosphamide, methotrexate, fluorouracil). The combination of paclitaxel plus vinorelbine was given as first-line chemotherapy for metastatic disease to 9 patients and as second- or third-line to the remaining 24 patients. The mean number of metastatic sites was 2 (range 1-5). Twenty-two patients had visceral involvement. Overall, 3 complete and 13 partial responses were observed among the 33 patients (objective response rate 48.5%, 95% confidence interval 31% to 66.5%). The response rate in patients receiving the regimen as first-line chemotherapy was 67% (6/9 patients), compared to 42% (10/24) in those receiving the regimen as second- or third-line chemotherapy. Primary anthracycline-resistant patients showed a response rate of 60% (6/10), whereas the remaining patients had a response rate of 43.5% (10/23). The main toxicities were grade 3 alopecia (92%), grade 3-4 neutropenia (28%), neutropenic fever (16%), grade 1-2 peripheral neuropathy (44%), arthralgias-myalgias (32%), and hypersensitivity reactions (8%). Phlebitis was a significant clinical problem in patients receiving the drugs through a peripheral vein.