Treatment of advanced breast cancer with vinorelbine and docetaxel with orwithout human granulocyte colony-stimulating factor

Purpose: A multicenter phase II trial was performed to investigate the effi cacy and tolerance of docetaxel, vinorelbine with or without recombinant hu man granulocyte colony-stimulating factor (G-CSF) in patients with metastat ic breast cancer. Patients and Methods: Between February 1998 and March 1999, 57 patients par ticipated in this trial. Forty-two patients received this combination as fi rst-line and 15 patients as second-line chemotherapy, including 10 patients who had failed anthracyclines. Therapy consisted of vinorelbine 30 mg/m(2) on days 1 and 15 and docetaxel 30 mg/m(2) on days 1, 8, and 15 every 4 wee ks. Depending on the absolute neutrophil counts on the day of scheduled che motherapeutic drug administration, a 5-day course of G-CSF 5 mug/kg/d was g iven. Results: The overall response rate was 64.3% (95% confidence interval, 48.1 % to 78.4%) in patients receiving docetaxel plus vinorelbine as first-line chemotherapy, including eight complete (19%) and 19 partial remissions (45. 3%); 11. patients (26.2%) had disease stabilization, and only four (9.5%) p rogressed. Second-line treatment with this regimen resulted in eight (53.3% ) of 15 objective responses, four had stable disease, and three had progres sive disease. The median time to progression was 12 months in the first-lin e and 9.8 months in the second-line setting, respectively. After a median f ollow-up time of 18 months, 38 patients (65%) were still alive with metasta tic disease. Myelosuppression was commonly observed; World Health Organizat ion grade 3 or 4 neutropenia both occurred in 18 patients (32%) and was com plicated by septicemia in four cases; grade 3 or 4 thrombocytopenia was see n in two patients (4%), and grade 3 anemia was seen in only one patient (2% ). Severe (grade 3) nonhematologic toxicity, except for alopecia, was rarel y observed and included nausea/vomiting in two patients (4%), and stomatiti s, peripheral neuropathy, and skin toxicity each in one patient. Conclusion: Our data suggest that docetaxel and vinorelbine with or without G-CSF is an effective and fairly well tolerated regimen for the treatment of advanced breast cancer. It might be particularly useful in patients prev iously exposed to adjuvant or palliative anthracyclines and/or alkylating a gents. (C) 2001 by American Society of Clinical Oncology.