1. Biweekly gemcitabine plus vinorelbine in first-line metastatic breast cancer: efficacy and correlation with HER2 extracellular domain
- Author
-
Jose I. Mayordomo, Hernán Cortés-Funes, J. Rifa, Javier Hornedo, Belén Ojeda, Eva Ciruelos, David Vicente, Ramon Colomer, Antonio Llombart-Cussac, and Ignasi Tusquets
- Subjects
Adult ,Oncology ,Cancer Research ,medicine.medical_specialty ,genetic structures ,Receptor, ErbB-2 ,Breast Neoplasms ,Enzyme-Linked Immunosorbent Assay ,Kaplan-Meier Estimate ,Adenocarcinoma ,Neutropenia ,Vinblastine ,Vinorelbine ,Deoxycytidine ,Breast cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Medicine ,Aged ,Aged, 80 and over ,business.industry ,Cancer ,General Medicine ,Middle Aged ,medicine.disease ,Gemcitabine ,Metastatic breast cancer ,Regimen ,Female ,business ,Febrile neutropenia ,medicine.drug - Abstract
Purpose. To assess the toxicity and efficacy of biweekly gemcitabine plus vinorelbine in first-line advanced breast cancer, and to establish whether circulating HER2 ECD levels correlate with the efficacy of the combination. Patients and methods. 52 patients were treated with gemcitabine 2500 mg/m(2) plus vinorelbine 30 mg/m(2), both on day 1 of 14-day cycles, for a maximum of 10 cycles. Baseline serum levels of HER2 ECD were assessed with an ELISA. Results. All patients were evaluable for toxicity, and 50 for efficacy. Overall toxicity was moderate. Grade 3 neutropenia occurred in 35% of patients and grade 4 in 19%. Other grade 3 toxicities were observed in less than 6%. There was one episode of febrile neutropenia, and one death after cycle three. Overall response rate was 52% (95% CI: 38% to 66%), with 2 patients achieving a CR (4%). Response rate did not correlate with HER2 ECD, with 50% of HER2 ECD positive patients responding, vs 48.5% of the HER2 ECD negative. Median overall survival was 24.6 months. Conclusion. Gemcitabine plus vinorelbine, given as an every-two-week schedule, is an active regimen in advanced breast carcinoma. This combination can be an option when anthracyclines and taxanes are not preferred. HER2 ECD has no predictive value in this non-taxane combination.
- Published
- 2006