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Annals of Oncology 2006 17(9):1379-1385; doi:10.1093/annonc/mdl134
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© 2006 European Society for Medical Oncology

breast cancer

Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage?

R Leonard1,*, J O'Shaughnessy2, S Vukelja3, V Gorbounova4, CA Chan-Navarro5, D Maraninchi6, N Barak-Wigler7, JJ McKendrick8, WG Harker9, AS Bexon10 and C Twelves11

1 Southwest Wales Cancer Institute, Singleton Hospital, Swansea, UK
2 Baylor-Sammons Cancer Center, Dallas and US Oncology, Houston, TX, USA
3 Tyler Cancer Center, Tyler, TX, USA
4 Institute of Clinical Oncology, Cancer Research Center RAMS, Moscow, Russia
5 Hospital de Especialidades, C.M.N.O. and UNIMEF Federalismo, Dirección de Pensiones del Estado de Jalisco, Guadalajara, Mexico
6 Institut Paoli-Calmettes, Marseille, France
7 Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
8 Box Hill Hospital, Melbourne, Australia
9 Utah Cancer Specialists, Salt Lake City, UT, USA
10 F. Hoffmann-La Roche Ltd, Nutley, NJ, USA
11 Tom Connors Cancer Research Centre, University of Bradford, Bradford, UK

*Correspondence to: Dr R. Leonard, Southwest Wales Cancer Institute, Singleton Hospital, Swansea SA2 8QA, UK. Tel: +44-1792-285-299; Fax: +44-1792-285-201; E-mail: robert.leonard{at}swansea-tr.wales.nhs.uk

Background: In a phase III trial, 3-weekly capecitabine (1250 mg/m2 twice daily days 1–14) plus docetaxel (75 mg/m2 day 1) demonstrated significantly superior overall survival to 3-weekly docetaxel (100 mg/m2 day 1). We report a retrospective analysis of the impact of capecitabine/docetaxel dose reduction on safety and efficacy.

Patients and methods: Safety and efficacy data were analyzed retrospectively according to the actual doses of capecitabine and docetaxel administered.

Results: More patients receiving capecitabine/docetaxel (65%) had dose reductions for adverse events than docetaxel alone (35%). In most patients requiring dose reduction with the combination (80%), capecitabine and docetaxel were simultaneously reduced to 950 mg/m2 and 55 mg/m2, respectively. Subsequently, there were fewer cycles (17%) with grade 3/4 adverse events than with the full doses (34%). Time to progression and overall survival appeared to be similar in patients starting the second cycle with reduced doses of capecitabine/docetaxel and those who continued to receive full doses of capecitabine/docetaxel for at least the first four cycles.

Conclusions: Capecitabine/docetaxel dosing flexibility allows management of side-effects without compromising efficacy. This retrospective analysis, as well as multiple phase II studies of taxanes with reduced-dose capecitabine, shows that reducing the starting dose of capecitabine with docetaxel is a reasonable strategy for the treatment of patients with metastatic breast cancer. In addition, reducing the dose of both agents may be appropriate.

Key words: capecitabine, docetaxel, metastatic breast cancer, safety, dose reduction


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