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Annals of Oncology Advance Access published online on November 10, 2005
Annals of Oncology, doi:10.1093/annonc/mdj033
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© 2005 European Society for Medical Oncology
Received May 9, 2005
Revised August 26, 2005
Accepted September 5, 2005

original article

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

F. Di Costanzo 1*, S. Gasperoni 1, P. Papaldo 2, D. Bilancia 3, L. Manzione 3, E. Landucci 1, F. Mazzoni 1, F. Cognetti 2, and 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, Italy
2 Oncologia Medica A, Polo Oncologico S. Raffaele, Regina Elena, Roma, Italy
3 U.O. Oncologia Medica Azienda Ospedaliera, S. Carlo Potenza, Italy

* To whom correspondence should be addressed.
F. Di Costanzo, E-mail: oncmed02{at}ao-careggi.toscana.it


  Abstract

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.

Keywords: capecitabine; metastatic breast cancer; weekly paclitaxel.
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