Vinorelbine as first-line chemotherapy for advanced breast cancer in women60 years of age or older

Background: Older patients with advanced breast cancer are less likely to r eceive chemotherapy than younger patients. Vinorelbine is an attractive alt ernative in this setting because of its clinical activity and low frequency of side effects. This multicenter, phase II trial was designed to assess t he safety and efficacy of intravenous vinorelbine as first-line therapy in women greater than or equal to 60 years old. Patients and methods: Fifty-six women (median age, 72 years; range 60-84 ye ars), with measurable advanced breast cancer and no prior chemotherapy for metastatic disease, were enrolled and included in the analysis. Vinorelbine 30 mg/m(2) was administered weekly for 13 weeks and then every two weeks u ntil development of progressive disease; doses were reduced or delayed to m anage toxicity. Results: The objective response rate was 38% (95% confidence interval (95% CI): 24%-51%); median duration of response, nine months; median time to dis ease progression in all patients, six months. The major dose-limiting toxic ity was hematologic, which led to a median dose intensity of 20.6 mg/m(2)/w eek. Grade 3-4 nonhematologic toxicity consisted of asthenia (7%); nausea a nd generalized pain (5%); vomiting, chest pain, abdominal pain, and elevate d AST (4%); fever, diarrhea, constipation, and injection site reaction (2%) . Neurotoxicity and alopecia were grade 1-2 and relatively infrequent. Conclusions: Vinorelbine offers a promising alternative for the management of advanced breast cancer in elderly patients who are concerned about the s ubjective side effects of cytotoxic chemotherapy. The dose-limiting toxicit y is neutropenia, which is readily managed with dose adjustment. Nonhematol ogic toxicity, including gastrointestinal side effects, is minimal. Randomi zed studies are warranted to compare the activity of vinorelbine with that of other regimens in elderly patients.