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

Authors: Canavese G.2; Venturini M.1; Rosso R.1; Del Mastro L.1; Garrone O.3; Angiolini C.1; Merlano M.3; Bergaglio M.1; Tolino G.1; Lambiase A.4; Baldini A.4

Source: Annals of Oncology, Volume 13, Number 4, 26 April 2002 , pp. 546-552(7)

Publisher: Oxford University Press

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Abstract:

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.

Keywords: Key words: advanced breast cancer; capecitabine; docetaxel; epirubicin; phase I

Document Type: Original article

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

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