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Journal of Clinical Oncology, Vol 20, Issue 12 (June), 2002: 2812-2823
© 2002 American Society for Clinical Oncology

Superior Survival With Capecitabine Plus Docetaxel Combination Therapy in Anthracycline-Pretreated Patients With Advanced Breast Cancer: Phase III Trial Results

By Joyce O’Shaughnessy, David Miles, Svetislava Vukelja, Vladimir Moiseyenko, Jean-Pierre Ayoub, Guadalupe Cervantes, Pierre Fumoleau, Stephen Jones, Wing-Yiu Lui, Louis Mauriac, Chris Twelves, Guy Van Hazel, Shailendra Verma, Robert Leonard

From the Baylor-Sammons Cancer Center, Dallas, and US Oncology, Houston, TX; Guy’s Hospital, London, United Kingdom; Petrov Research Institute, St Petersburg, Russia; Hopital Notre Dame, Montreal, and Ottawa Regional Cancer Centre, Ottawa, Canada; Issste Hospital, Mexico City, Mexico; Centre Rene Gauducheau Nantes-Atlantique, Saint Herblain, and Institut Bergonié, Bordeaux, France; Taipei-Veterans General Hospital, Taiwan; Beatson Oncology Centre, Glasgow, and Western General Hospital, Edinburgh, Scotland; and Perth Oncology, Perth, Western Australia.

Address reprint requests to Joyce O’Shaughnessy, MD, Baylor-Sammons Cancer Center and US Oncology, 3535 Worth St, 5th Floor, Dallas, TX 75246; email: joyce.o'shaughnessy{at}usoncology.com

PURPOSE: Docetaxel and capecitabine, a tumor-activated oral fluoropyrimidine, show high single-agent efficacy in metastatic breast cancer (MBC) and synergy in preclinical studies. This international phase III trial compared efficacy and tolerability of capecitabine/docetaxel therapy with single-agent docetaxel in anthracycline-pretreated patients with MBC.

PATIENTS AND METHODS: Patients were randomized to 21-day cycles of oral capecitabine 1,250 mg/m2 twice daily on days 1 to 14 plus docetaxel 75 mg/m2 on day 1 (n = 255) or to docetaxel 100 mg/m2 on day 1 (n = 256).

RESULTS: Capecitabine/docetaxel resulted in significantly superior efficacy in time to disease progression (TTP) (hazard ratio, 0.652; 95% confidence interval [CI], 0.545 to 0.780; P = .0001; median, 6.1 v 4.2 months), overall survival (hazard ratio, 0.775; 95% CI, 0.634 to 0.947; P = .0126; median, 14.5 v 11.5 months), and objective tumor response rate (42% v 30%, P = .006) compared with docetaxel. Gastrointestinal side effects and hand-foot syndrome were more common with combination therapy, whereas myalgia, arthralgia, and neutropenic fever/sepsis were more common with single-agent docetaxel. More grade 3 adverse events occurred with combination therapy (71% v 49%, respectively), whereas grade 4 events were slightly more common with docetaxel (31% v 25% with combination).

CONCLUSION: The significantly superior TTP and survival achieved with the addition of capecitabine to docetaxel 75 mg/m2, with the manageable toxicity profile, indicate that this combination provides clear benefits over single-agent docetaxel 100 mg/m2. Docetaxel/capecitabine therapy is an important treatment option for women with anthracycline-pretreated MBC.

Some authors have received more than $2,000 a year working in a consultant capacity or by performing contract work within the past 2 years for either Roche, Nutley, NJ, or Aventis, Bridgewater, NJ (D.M., S.Vukelja, P.F., and R.L.) or both (J.O., S.J., C.T., and G.V.H).


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Postoperative Adjuvant Therapy With Tamoxifen, Tegafur Plus Uracil, or Both in Women With Node-Negative Breast Cancer: A Pooled Analysis of Six Randomized Controlled Trials
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W. J. Gradishar, L. A. Meza, B. Amin, D. Samid, T. Hill, Y.-M. Chen, E. E. Lower, and P. K. Marcom
Capecitabine Plus Paclitaxel As Front-Line Combination Therapy for Metastatic Breast Cancer: A Multicenter Phase II Study
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J. Crown, M. O'Leary, and W.-S. Ooi
Docetaxel and Paclitaxel in the Treatment of Breast Cancer: A Review of Clinical Experience
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P. M. Hoff, R. Pazdur, Y. Lassere, S. Carter, D. Samid, D. Polito, and J. L. Abbruzzese
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Results of Two Open-Label, Multicenter Phase II Studies of Docetaxel, Platinum Salts, and Trastuzumab in HER2-Positive Advanced Breast Cancer
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G. W. Sledge Jr
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