© 2004 European Society for Medical Oncology
Original Article |
A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer
1 Medical Oncology Service, Vall d'Hebron University Hospital, Barcelona; 2 Medical Oncology Service, Instituto Valenciano de Oncología, Valencia; 3 Medical Oncology Service, Hospital Clínico, Valencia; 5 Medical Oncology Service, H.U. Germans Trias i Pujol, Badalona; 6 Medical Oncology Service, H.U. Miguel Servet, Zaragoza; 8 Medical Oncology Service, H.U. Lozano Blesa, Zaragoza; 9 Aventis Pharma, Madrid, Spain; 4 Medical Oncology Service, Universitair Ziekenhuis Antwerpen, Edegem; 7 Medical Oncology Service, H. Sant-Jean, Brussels, Belgium
* Correspondence to: Dr J. Baselga, Chairman and Professor of Medicine, Medical Oncology Service, Vall d'Hebron University Hospital, P. Vall d'Hebron, 119–129, 08035 Barcelona, Spain. Tel: +34-93-274-6085; Fax: +34-93-274-6059; Email: jbaselga{at}vhebron.net
Background: A phase II randomised trial was conducted to evaluate the tolerability and activity of weekly or 3-weekly docetaxel in patients with metastatic breast cancer.
Patients and methods: Eighty-three patients with histologically proven metastatic breast cancer were randomised to receive either docetaxel 40 mg/m2 weekly for 6 consecutive weeks followed by 2 weeks without treatment (n=41), or docetaxel 100 mg/m2 on day 1 every 3 weeks (n=42).
Results: The incidence of all grade 3–4 adverse events was higher in the 3-weekly group than in the weekly group (96 versus 44), and the number of patients with grade 3–4 adverse events was also greater in the 3-weekly group (31 versus 20). Analysis of individual adverse events tended to favour the weekly regimen. Intent-to-treat overall response rate was 34% and 33% in the weekly and 3-weekly groups, respectively. Median time to progression was 5.7 and 5.3 months after weekly and 3-weekly docetaxel, respectively, and median time to treatment failure was 4.1 and 4.9 months, respectively.
Conclusion: Weekly docetaxel is an active regimen in metastatic breast cancer with comparable efficacy to 3 weekly docetaxel. Although both schedules were well tolerated, weekly docetaxel appears to have a more favourable toxicity profile.
Key words: docetaxel, metastatic breast cancer, randomised trial
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