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Mature analysis from women's intervention nutrition study (WINS)

[32] Mature analysis from the women's intervention nutrition study (WINS) evaluating dietary fat reduction and breast cancer outcome.

Chlebowski RT, Blackburn GL, Elashoff RM, Hoy KM, Thomson CA, Nixon DW, Giuliano AE, McAndrew P, Hudis C, Butler J, Merkel D, Shapiro A.

LABioMed, Torrance, CA; Beth Israel Deaconess Hospital, Boston, MA; University of California, Los Angeles, CA; Cancer Prevention Institute, New York, NY; University of Arizona, Tucson, AZ; St Johns Hospital and Health Center, Santa Monica, CA; Cedars Sinai Hospital, Beverly Hills, CA; Memorial Sloan-Kettering Cancer Center, New York, NY; University of California at Irvine, City of Orange, CA; Evanston Hospital, Kellogg Cancer Care Center, Evanston, IL; Park Nicollet Institute, Minneapolis, MN

Background: We have previously initiated a randomized clinical trial evaluating the relationship between dietary fat intake and breast cancer outcomes.

Material and Methods: A randomized, prospective, multi-center clinical trial was conducted to test whether dietary intervention designed to reduce fat intake was more effective than a control condition in women with resected early stage breast cancer receiving conventional cancer management. The primary endpoint was relapse-free survival.

Results: A total of 2,437 women were randomized 40:60 to dietary intervention or control groups between 1997 and 2001. Dietary fat intake was lower in the intervention compared to the control group (fat grams/day at 12 months, 33.3 + 17.0 mean + standard deviation (SD) versus 51.3 + 24.4, respectively, P<0.001) corresponding with a significantly lower (P=0.005) mean body weight in the intervention group as well.

After a median of 60 months (data through October 2003) an interim efficacy analysis was reported in May, 2005 (Chlebowski et al, Proc Amer Soc Clin Onc 2005;24:10). A total of 277 events (local, regional, distant, or ipsilateral breast cancer recurrence or new contralateral breast cancer) were reported: 96 of 975 in the dietary group and 181 of 1462 in the control group.

The hazard ratio in the intervention compared with the control group was 0.76 (95% confidence interval 0.60- 0.98, P=0.077 for stratified log rank and P=0.034 for adjusted Cox model analysis). Exploratory analyses suggested a differential dietary effect based on hormonal receptor status. The dietary intervention was ended in May 2004.

Non-intervention follow-up has continued and the database will be closed at the end of September 2006, resulting in an estimated median follow-up of 95 months in surviving patients.

Discussion: A mature analysis of WINS will meet original protocol design plans and provide a more definitive assessment of the relationship between dietary fat intake and breast cancer patient outcome.

San Antonio Breast Cancer Symposium, 12/06

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