Originally published as JCO Early Release 10.1200/JCO.2007.15.8485 on March 9 2009

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

From the Nottingham City Hospital, Nottingham; Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood; and Royal Free Hospital, Hampstead, United Kingdom; Centre Val d'Aurelle, Montpellier; Centre François Baclesse, Caen Cedex; and Centre François Baclesse, Saint Cloud; Eli Lilly & Co, CITY; and Centre François-Georges Leclerc, Dijon, France; Universität Tübingen, Tübingen; and University of Heidelberg, Heidelberg; HSK, Dr. Horst Schmidt Klinik, Wiesbaden; and Universitaetsfrauenklinik, Prittwitzstrasse, Germany; Hospital Clínico Universitario de Valencia; and Instituto Valenciano de Oncologia, Valencia; Hospital Clinico Universitario Lozano Blesa; and Hospital Universitario Miguel Servet, Zaragoza; and Eli Lilly & Co, Alcobendas, Spain; and Eli Lilly & Co, Copenhagen, Denmark.

Corresponding author: Stephen Chan, MD, Nottingham University Hospital, City Campus, Hucknall Rd, Nottingham, NG5 United Kingdom; e-mail: steve.chan{at}nuh.nhs.uk.

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.

Supported by Eli Lilly & Co.

Presented in part at the 41st American Society of Clinical Oncology Annual Meeting, May 13-17, 2005, Orlando, FL; the 42nd American Society of Clinical Oncology Annual Meeting, June 2-6, 2006, Atlanta, GA; and the 30th Annual San Antonio Breast Cancer Symposium, December 13-16, 2007, San Antonio, TX.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

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