Phase III Study of Gemcitabine Plus Docetaxel Compared with Capecitabine Plus Docetaxel for Anthracycline-Pretreated Patients with Metastatic Breast Cancer

Chan, S. ; Romieu, G. ; Huober, J. ; Delozier, T. ; Tubiana-Hulin, M. ; Schneeweiss, A. ; Lluch, A. ; Llombart, A. ; Du Bois, A. ; Kreienberg, R. ; Mayordomo, J. I. (Universidad de Zaragoza) ; Anton, A. (Universidad de Zaragoza) ; Harrison, M. ; Jones, A. ; Carrasco, E. ; Vaury, A. T. ; Frimodt-Moller, B. ; Fumoleau, P.

Resumen: Purpose Patients with metastatic breast cancer who are pretreated with anthracyclines frequently receive taxane-based combinations. This phase III study compared the efficacy and safety of gemcitabine- docetaxel (GD) with capecitabine-docetaxel (CD) in advanced breast cancer. Patients and Methods Patients were randomly assigned to GD (G 1,000 mg/m2 days 1 and 8; D 75 mg/m2 day 1) or CD (C 1,250 mg/m2 twice daily days 1 through 14; D 75 mg/m2 day 1) every 21 days. Comparison of progression-free survival (PFS) was the primary objective. Results Patient characteristics were balanced between arms (N ! 305). Median PFS was 8.05 months (95% CI, 6.60 to 8.71) for GD and 7.98 (95% CI, 6.93 to 8.77) for CD (log-rank P ! .121). Overall response rate (ORR) was 32% in both arms, and overall survival (OS) was not different between arms (P ! .983). Time to treatment failure (TTF; defined as discontinuation, progressive disease, death as a result of any cause, or the start of a new anticancer therapy) was superior in the GD arm (P ! .059). Hematologic toxicity was similar in both arms, except for grades 3 to 4 leukopenia (GD, 78%; CD, 66%; P ! .025) and transfusions (GD, 17%; CD, 7%; P ! .0051). Grades 3 to 4 diarrhea, mucositis, and hand-and-foot syndrome were significantly higher in the CD arm. Fewer patients in the GD arm discontinued because of drug-related adverse events (13% v 27% in CD; P ! .002). Conclusion No difference was observed between GD and CD arms in PFS, ORR, and OS. TTF was longer in the GD arm. These findings, combined with a nonhematologic toxicity profile that favors GD over approved doses of CD, suggest that gemcitabine may be a better option than capecitabine in combination with docetaxel in this clinical setting.

Idioma: Inglés

Año: 2009

Publicado en: JOURNAL OF CLINICAL ONCOLOGY 27, 11 (2009), 1753-1760
ISSN: 0732-183X

Factor impacto JCR: 17.793 (2009)

Categ. JCR: ONCOLOGY rank: 4 / 164 = 0.024 (2009) - Q1 - T1

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)