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Annals of Oncology Advance Access originally published online on July 27, 2006
Annals of Oncology 2006 17(10):1529-1532; doi:10.1093/annonc/mdl168
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© 2006 European Society for Medical Oncology

gastrointestinal tumors

Weekly docetaxel and capecitabine is not effective in the treatment of advanced gastric cancer: a phase II study

M Orditura1, E Martinelli1, G Galizia2, C Carlomagno3, G Aurilio1, L Vecchione1, Eva Lieto2, S De Placido3, G Catalano1, F Ciardiello1 and F De Vita1,*

1 Dipartimento Medico Chirurgico di Internistica Clinica e Sperimentale ‘F. Magrassi e A. Lanzara Cattedra di Oncologia Medica
2 Cattedra di Chirurgia Generale ed Epatobiliare, Seconda Università degli Studi di Napoli
3 Dipartimento di Endocrinologia ed Oncologia Molecolare e Clinica, Università Federico II Napoli, Naples, Italy

*Correspondence to: Dr F. De Vita, Chair of Medical Oncology, ‘F. Magrassi & A. Lanzara’ Department of Clinical and Experimental Medicine, Second University of Naples School of Medicine, Naples, Italy. Tel: +39-081-5666713; Fax: +39-081-5666728; E-mail: fernandodevita{at}yahoo.it

Background: Capecitabine and docetaxel have demonstrated preclinical antitumor synergy and activity in advanced gastric cancer. We assessed the clinical activity and the toxicity of weekly docetaxel in combination with capecitabine in untreated patients with advanced gastric cancer.

Patients and methods: A total of 38 patients were treated with docetaxel 36 mg/m2 on days 1, 8, and 15 i.v., plus capecitabine, 625 mg/m2 bid per os on days 5 to 18 repeated every 4 weeks.

Results: All patients were assessable for response to treatment and for toxicity. Major responses were observed in eight patients (21%), with three patients achieving a CR (7.8%) and five showing a PR (13%). The median time to progression was 5.4 months and the overall survival was 7.7 months. The safety profile of this schedule was acceptable with a low rate of myelossuppression, diarrhoea and hand-foot syndrome.

Conclusions: The combination of docetaxel and capecitabine at the doses and schedule investigated in this study is safe, but does not show significant activity in untreated patients with advanced gastric cancer.

Key words: docetaxel, capecitabine, gastric cancer


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