Docetaxel plus vinorelbine as salvage chemotherapy in advanced breast cancer: a phase II study.
CONCLUSIONS
Administration of a combined regimen of docetaxel plus vinorelbine every 4 weeks is feasible and shows activity in heavily pretreated patients with advanced breast cancer.


OBJECTIVE
To determine the activity and tolerance of docetaxel plus vinorelbine in heavily pretreated patients with advanced breast cancer.


METHODS
Thirty-five metastatic breast cancer patients with ECOG performance status of 0-2 received docetaxel (80 mg/m2 given intravenously) on day 1 and vinorelbine (30 mg/m2 given intravenously) on days 1 and 14, every 4 weeks. The median number of prior chemotherapy regimens was 2 (range: 1-4). Twenty-five patients (71.4%) had been treated previously using intensive therapy approaches with peripheral blood-derived stem cell (PBSC) support, including high-dose chemotherapy (11 patients), multicyclic dose-intensive chemotherapy supported with repeated PBSC infusions (seven patients), or both (seven patients). Twenty-eight patients (80%) received previous chemotherapy for metastatic disease. Adjuvant therapy in the remaining seven patients consisted of high-dose chemotherapy and PBSC support or an anthracycline-containing regimen.


RESULTS
The total number of courses was 229, and the median number of courses per patient was 6 (range: 1-16). There was one toxic death (2.8%). Grade 3-4 toxicities included mucositis (17.1%), neutropenia (37.1%), anemia (5.7%), vomiting (2.9%), and asthenia (14.3%). Eighteen patients (58%; 95% CI: 40.6-75.4%) achieved an objective response, including four complete responses (12.9%) and 14 partial responses (45.1%). Overall response rate was 51.4% (95% CI: 34.8-67.9%). After a median follow-up of 20 months (range: 2-42), overall survival was 20 months (95% CI: 16-24), and median time to progression was 13 months (95% CI: 7-19).


CONCLUSIONS
This combination shows activity and an acceptable toxicity profile in patients with advanced breast cancer.
Rodríguez
Javier
J
Department of Oncology, Clínica Universitaria de Navarra, Pamplona, Spain. jrodriguez@unav.es
Calvo
Emiliano
E
Cortes
J
J
Santisteban
Marta
M
Perez-Calvo
J
J
Martínez-Monge
Rafael
R
Brugarolas
Antonio
A
Fernández-Hidalgo
Oscar
O
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016879:Salvage Therapy; D043823:Taxoids; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine