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Phase III Study of Cyclophosphamide, Doxorubicin, and Fluorouracil (CAF) Plus Leucovorin Versus CAF for Metastatic Breast Cancer: Cancer and Leukemia Group B 9140

H.L. Parnes, C. Cirrincione, J. Aisner, D.A. Berry, S.L. Allen, J. Abrams, E. Chuang, M.R. Cooper, M.C. Perry, D.B. Duggan, T.P. Szatrowski, I.C. Henderson, L. Norton

From the National Cancer Institute, Bethesda, MD; University of Texas M.D. Anderson Cancer Center, Houston, TX; CALGB Statistical Center, Durham; Wake Forest University School of Medicine, Winston-Salem, NC; Cancer Institute of New Jersey, New Brunswick; Hoffman LaRoche Inc, Nutley, NJ; Weill Medical College of Cornell University, Memorial Sloan-Kettering Cancer Center, New York; SUNY Upstate Medical Center, Syracuse; North Shore University Hospital, Manhasset, NY; University of Missouri/Ellis Fischel Cancer Center, Columbia, MO; and University of California at San Francisco, San Francisco, CA.

Address reprint requests to Howard L. Parnes, MD, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, 6130 Executive Plaza EPN Room 2100, Rockville MD 20852; email: hp24c{at}nih.gov.

Purpose: To determine whether biochemical modulation with LV (leucovorin) enhances the efficacy of CAF (cyclophosphamide, doxorubicin, and fluorouracil) against metastatic breast cancer.

Patients and Methods: Women with histologically confirmed stage IV breast cancer, Cancer and Leukemia Group B (CALGB) performance status 0 to 2, and no prior chemotherapy for metastatic disease were randomly assigned to receive CAF (cyclophosphamide 500 mg/m² day 1, doxorubicin 40 mg/m² day 1, and fluorouracil [FU] 200 mg/m² intravenous bolus days 1 to 5) with or without LV (LV 200 mg/m² over 30 minutes days 1 to 5 given 1 hour before FU).

Results: Two hundred forty-two patients were randomly assigned to treatment; 124 patients had visceral crisis and 40 patients had a CALGB performance status score of 2. The median follow-up was 6 years. The two study arms were similar with regard to serious adverse events; four patients died from treatment-related causes, two patients on each study arm. Predictive variables for time to treatment failure and survival were visceral disease and performance status. The overall response rate was 29% for CAF versus 28% for CAF plus LV. The median time to treatment failure (9 months) and median survival (1.7 years) did not differ by treatment arm.

Conclusion: Modulation of CAF with LV improved neither response rates nor survival among women with metastatic breast cancer, compared with CAF alone. Multivariate analyses confirmed the prognostic importance of performance status and visceral crisis. However, the overall and complete response rates, response durations, time to treatment failure, and survival were the same in the two treatment arms.

Supported in part by grants from the National Cancer Institute (CA31946), National Institutes of Health, Department of Health and Human Services, Bethesda, MD, to the Cancer and Leukemia Group B. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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