© The Author 2006. Published by Oxford University Press.
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Dietary Fat Reduction and Breast Cancer Outcome: Interim Efficacy Results From the Women's Intervention Nutrition Study
Affiliations of authors: Department of Medicine, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA (RTC); Department of Nutrition, Beth Israel Deaconess Hospital, Boston, MA (GLB); Department of Family and Community Medicine, University of Arizona, Tucson, AZ (CAT); Department of Medicine, Cancer Prevention Institute, New York, NY (DWN, MKH); Department of Oncology Research, Park Nicollet Institute, Minneapolis, MN (AS); Department of Public Health Sciences and Epidemiology, University of Hawaii at Manoa, Honolulu, HI (MTG); Department of Surgery, John Wayne Cancer Institute, Los Angeles, CA (AEG); Science Programs Department, Kaiser Permanente Center for Health Research, Portland, OR (NK); Department of Hematology and Oncology, Tower Hematology and Oncology Medical Group, Beverly Hills, CA (PM); Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY (CH); Department of Surgical Oncology, University of California, Irvine, CA (JB); Department of Medical Oncology, Evanston Hospital, Kellogg Cancer Care Center, Evanston, IL (DM); Department of Epidemiology, Fred Hutchinson Cancer Research Center, Seatle, WA (AK); Division of Research, Kaiser Permanente Medical Group, Oakland, CA (BC); Department of Radiation Oncology, St. Barnabas Medical Center, Livingston, NJ (RM); Don Monti Division of Medical Oncology, North Shore University Hospital, Manhasset, NY (VV); Division of Hematology and Oncology, Bennett Cancer Center, Stamford, CT (SDP); Division of Surgical Research, Rhode Island Hospital, Providence, RI (MW); Division of Medical Oncology and Hematology, Medical University of South Carolina, Charleston, SC (RH); Division of Medical Oncology and Hematology, Wayne State University, Detroit, MI (MS); Campbell's Soup Co., Camden, NJ (BLW); Department of Biomathematics, University of California, Los Angeles, CA (RME)
Correspondence to: Rowan T. Chlebowski, MD, PhD, Divisions of Medical Oncology and Hematology, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 West Carson St., Building J-3, Torrance, CA 90502-2064 (e-mail: rchlebow{at}whi.org).
Background: Preclinical and observational studies suggest a relationship between dietary fat intake and breast cancer, but the association remains controversial. We carried out a randomized, prospective, multicenter clinical trial to test the effect of a dietary intervention designed to reduce fat intake in women with resected, early-stage breast cancer receiving conventional cancer management. Methods: A total of 2437 women were randomly assigned between February 1994 and January 2001 in a ratio of 40 : 60 to dietary intervention (n = 975) or control (n = 1462) groups. An interim analysis was performed after a median follow-up of 60 months when funding for the intervention ceased. Mean differences between dietary intervention and control groups in nutrient intakes and anthropometric variables were compared with t tests. Relapse-free survival was examined using Kaplan–Meier analysis, stratified log-rank tests, and Cox proportional hazards models. Statistical tests were two-sided. Results: Dietary fat intake was lower in the intervention than in the control group (fat grams/day at 12 months, 33.3 [95% confidence interval {CI} = 32.2 to 34.5] versus 51.3 [95% CI = 50.0 to 52.7], respectively; P<.001), corresponding to a statistically significant (P = .005), 6-pound lower mean body weight in the intervention group. A total of 277 relapse events (local, regional, distant, or ipsilateral breast cancer recurrence or new contralateral breast cancer) have been reported in 96 of 975 (9.8%) women in the dietary group and 181 of 1462 (12.4%) women in the control group. The hazard ratio of relapse events in the intervention group compared with the control group was 0.76 (95% CI = 0.60 to 0.98, P = .077 for stratified log rank and P = .034 for adjusted Cox model analysis). Exploratory analyses suggested a differential effect of the dietary intervention based on hormonal receptor status. Conclusions: A lifestyle intervention reducing dietary fat intake, with modest influence on body weight, may improve relapse-free survival of breast cancer patients receiving conventional cancer management. Longer, ongoing nonintervention follow-up will address original protocol design plans, which called for 3 years of follow-up after completion of recruitment.
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Correspondence about this Article
- Re: Dietary Fat Reduction and Breast Cancer Outcome: Interim Efficacy Results From the Women's Intervention Nutrition Study
- Mevlut Kurt and Kadri Altundag
J Natl Cancer Inst 2007 99: 899-900.[Extract] [Full Text] [PDF]
- Re: Dietary Fat Reduction and Breast Cancer Outcome: Interim Efficacy Results From the Women's Intervention Nutrition Study
- John P. Pierce, Loki Natarajan, James Marshall, and Karen Messer
J Natl Cancer Inst 2007 99: 900.[Extract] [Full Text] [PDF]
Editorial about this Article
- Dietary Fat and Breast Cancer: Contributions From a Survival Trial
- Anne C. M. Thiébaut, Arthur Schatzkin, Rachel Ballard-Barbash, and Victor Kipnis
J Natl Cancer Inst 2006 98: 1753-1755.[Extract] [Full Text] [PDF]
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