Docetaxel and Vinorelbine as First Line Chemotherapy in Patients with Metastatic Breast Cancer

Purpose: To evaluate the antitumor activity and tolerance of docetaxel plus vinorelbine combination chemotherapy in metastatic breast cancer (MBC) patients, pretreated with anthracyclines as an adjuvant. Patients and Methods: Forty patients with metastatic breast cancer were treated with docetaxel 75mg/m2 day 1, plus vinorelbine 25mg/m2 on days 1 and 8, every 3 weeks. All patients had previously received anthracyclines as an adjuvant. Twenty six patients had single metastatic site and 14 patients had ³2 metastatic sites. Bone and liver were the predominant metastatic sites representing 40% and 32.5% respectively. Results: All 40 patients were assessable for response. Median number of cycles given per patient was 5 cycles (range 2-8). The overall response rate was 57.5% (23/40), with 12.5% of patients (5 patients) achieving complete response (CR) and 45% (18 patients) partial response (PR). Median duration of response was 7.5 months (range 3-10 months). Ten patients (25%) had stable disease and 7 (17.5%) had progressive disease. Median time to progression (TTP) and median overall survival (OS) were 10.5 months (SE 3.79, CI 95% 3.06-17.94) and 20 months (SE 2.85, CI 95% 14.42-25.58) respectively. There was no detected grade 4 toxicity. Eleven patients (27.5%) had grade 3 neutropenia, only one of them experienced febrile neutropenia requiring hospitalization. Grade 2 stomatitis was seen in 5 patients (12.5%), grade 1 peripheral neuropathy in 7 patients (17.5%), and grade 1 fluid retention in 5 patients (12.5%). There were no treatment-related deaths. Conclusion: The combination of docetaxel plus vinorelbine every 3 weeks is safe, well-tolerated and active as first-line treatment in MBC patients with prior anthracyclines exposure.