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Annals of Oncology 13:546-552, 2002
© 2002 European Society for Medical Oncology

Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer

M. Venturini1,+, L. Del Mastro1, O. Garrone3, C. Angiolini1, M. Merlano3, M. Bergaglio1, G. Tolino1, A. Lambiase4, A. Baldini4, G. Canavese2 and R. Rosso1

Divisions of 1Medical Oncology and 2Surgical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genova; 3Division of Medical Oncology, Ospedale S. Croce e Carle, Cuneo; 4Roche, Milano, Italy

Received 18 June 2001; revised 3 September 2001; accepted 20 September 2001.

Purpose

Capecitabine is an oral fluoropyrimidine with considerable activity and minimal myelosuppression and alopecia. This phase I study evaluated the addition of capecitabine to epirubicin/docetaxel combination therapy as first-line treatment for advanced breast cancer.

Patients and methods

Twenty-three female patients with advanced breast cancer received capecitabine (765–1060 mg/m2 twice daily on days 1–14 of a 3-week treatment cycle) in combination with epirubicin and docetaxel (75 mg/m2 i.v. on day 1).

Results

The maximum tolerated dose of capecitabine was 985 mg/m2 and the principal dose-limiting toxicity was febrile neutropenia. No grade 3/4 anemia or thrombocytopenia occurred. There were no grade 4 non-hematological events and grade 3 events other than alopecia were rare. Alopecia occurred in all patients and treatment cycles, and asthenia occurred in all patients and in 84% of treatment cycles. Other frequent adverse events included nausea, vomiting, fever, paresthesia and elevated transaminase levels. An objective response to treatment was observed in 91% (95% confidence interval 72% to 99%) of patients.

Conclusions

The addition of capecitabine to docetaxel/epirubicin combination therapy provides a well-tolerated and active first-line chemotherapy regimen in patients with advanced breast cancer, and merits phase II/III evaluation.

Key words: advanced breast cancer, capecitabine, docetaxel, epirubicin, phase I


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