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High-Dose Versus Standard Chemotherapy in Metastatic Breast Cancer: Comparison of Cancer and Leukemia Group B Trials With Data From the Autologous Blood and Marrow Transplant Registry

From the University of Texas M.D. Anderson Cancer Center, Houston, and University of Texas, Health Science Center at San Antonio, San Antonio, TX; Duke University Medical Center, Durham, NC; Autologous Blood and Marrow Transplant Registry, Milwaukee, and Health Policy Institute, Medical College of Wisconsin, Milwaukee, WI; Columbia University, Memorial Sloan-Kettering Cancer Center, New York, and Roswell Park Cancer Institute, Buffalo, NY; The Cancer Institute of New Jersey, New Brunswick, and Progenitor Cell Therapy LLC, Saddle Brook, NJ; Cancer and Leukemia Group B, Chicago, and Lutheran General Hospital, Park Ridge, IL; University of Massachusetts Medical Center, Boston, MA; University of Pennsylvania Cancer Center, Philadelphia, PA; University of California at San Francisco, San Francisco, CA; Case Western Reserve University, Cleveland, OH; National Cancer Institute, Bethesda, MD; University of Missouri/Ellis Fischel Cancer Center, Columbia, MO; Prince of Wales Hospital, Randwick Sydney, New South Wales, Australia; and Cancer Center of the Carolinas, Greenville, SC.

Address reprint requests to Donald A. Berry, PhD, Department of Biostatistics, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 447, Houston, TX 77030-4009; email: dberry{at}odin.mdacc.tmc.edu

PURPOSE: To assess survival of patients with metastatic breast cancer treated with high-dose chemotherapy (HDC) versus standard-dose chemotherapy (SDC).

PATIENTS AND METHODS: SDC in four Cancer and Leukemia Group B (CALGB) trials was compared with hematopoietic stem-cell support in patients from the Autologous Blood and Marrow Transplant Registry. Cox proportional hazard regression incorporated potentially confounding effects. A total of 1,509 women were enrolled onto CALGB trials, and 1,188 women received HDC. No significant survival differences existed by CALGB trial or HDC regimen. Consideration was restricted to candidates for both SDC and HDC. The resulting sample included 635 SDC and 441 HDC patients. The outcome of interest was overall survival.

RESULTS: The HDC group displayed better performance status. The SDC group had slightly better survival in first year after treatment. The HDC group had lower hazard of death from years 1 to 4 and had somewhat higher probability of 5-year survival (adjusted probabilities [95% confidence intervals], 23% [17% to 29%] v 15% [11% to 19%], P = .03).

CONCLUSION: After controlling for known prognostic factors in this nonrandomized analysis of two large independent data sets, women receiving HDC versus SDC for metastatic breast cancer have a similar short-term probability of survival, and might have a modestly higher long-term probability of survival.

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