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Annals of Oncology Advance Access originally published online on November 10, 2005
Annals of Oncology 2006 17(1):79-84; doi:10.1093/annonc/mdj033
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© 2005 European Society for Medical Oncology

Weekly paclitaxel plus capecitabine in advanced breast cancer patients: dose-finding trial of GOIRC and GOL

F. Di Costanzo1,*, S. Gasperoni1, P. Papaldo2, D. Bilancia3, L. Manzione3, E. Landucci1, F. Mazzoni1, F. Cognetti2 On behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC) and Gruppo Oncologico del Lazio (GOL)

1 U.O. Oncologia Medica, Azienda Ospedaliera Careggi, Firenze; 2 Oncologia Medica A, Polo Oncologico S. Raffaele, Regina Elena, Roma; 3 U.O. Oncologia Medica Azienda Ospedaliera, S. Carlo Potenza, Italy

* Correspondence to: Dr F. Di Costanzo, U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Careggi, Viale Pieraccini 17, 50139 Firenze, Italy. Tel: +39-55-4279648; Fax: +39-55-4277538; E-mail: oncmed02{at}ao-careggi.toscana.it

Background: Paclitaxel and capecitabine have demonstrated a synergic effect and significant antitumor activity in patients with advanced breast cancer. A weekly schedule of paclitaxel obtained a response rate of 50–68% in advanced breast cancer and less serious side-effects.

Patients and methods: Thirty-two patients with advanced breast cancer pretreated with chemotherapy were enrolled in a dose-finding trial to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of paclitaxel given on days 1, 8 and 15 of each cycle combined with capecitabine given twice daily from day 1 through day 14, every 21 days. Three patients were recruited at one of six dose levels (paclitaxel 70–100 mg/m2, capecitabine 1650–2500 mg/m2).

Results: Thirty-two patients were accrued and 31 were evaluated for toxicity. One DLT has been experienced at level VI as diarrhea grade 3. We determined dose level V as the MTD, but we recommend dose level IV for phase II studies (capecitabine 1250 mg/m2 orally twice daily plus paclitaxel 80 mg/m2 intravenously weekly), owing to cumulative toxicity at level V. The objective response rate was 43%.

Conclusions: Weekly paclitaxel plus capecitabine is a safety and active chemotherapy in previously treated metastatic breast cancer.

Key words: capecitabine, metastatic breast cancer, weekly paclitaxel


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