Low-Fat Dietary Pattern and Breast Cancer Mortality in the Women s Health Initiative (WHI) Randomized Controlled Trial
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1 Low-Fat Dietary Pattern and Breast Cancer Mortality in the Women s Health Initiative (WHI) Randomized Controlled Trial Chlebowski RT, MD, Aragaki AK, MS, Anderson GL, PhD, Thomson CA, PhD, Manson JE, MD, Simon MS, MD, Howard BV, PhD, Rohan TE, PhD, Snetselar L, PhD, Lane D, MD, Barrington W, PhD, Vitolins MZ, DrPH, Womack C, MD< Qi L, PhD, Hou L, MD, Thomas F, PhD, Prentice RL, PhD
2 Disclosure Information Clinical Trials Plenary Session Rowan T Chlebowski, MD, PhD Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center I have the following financial relationships to disclose: Consultant for: Novartis, Genentech, Amgen, Genomic Health, Novo Nordisk Speaker s Bureau for: Novartis, Genentech - and - I will not discuss off label use and/or investigational use in my presentation.
3 Background Dietary Fat Intake and Breast Cancer The Women s Health Initiative Dietary Modification (DM) Trial Study Design and Implementation Primary Breast Cancer Incidence Results (2006) Rationale for Secondary Analyses Current Results Deaths After Breast Cancer Deaths From Breast Cancer Breast Cancer Overall Survival
4 Country-by-Country Breast Cancer Death Rate by Estimated Dietary Fat Intake Carrol, et al. Can Med Assoc J 1968;98(12):590-4
5 Background Dietary Fat Intake and Breast Cancer The Women s Health Initiative Dietary Modification (DM) Trial Study Design and Implementation Primary Breast Cancer Incidence Results (2006) Rationale for Secondary Analyses Current Results Deaths After Breast Cancer Deaths From Breast Cancer Breast Cancer Overall Survival
6 WHI DIETARY MODIFICATION (DM) CLINICAL TRIAL Objective: To determine whether adoption of a low fat dietary pattern would reduce invasive breast cancer incidence Design and Setting: A randomized, controlled primary prevention trial conducted at 40 US clinical centers entering participants from Participants: 48,835 postmenopausal women, aged 50 to 79 years, without prior breast cancer, baseline dietary intake > 32% of total calories from fat mammogram not suspicious for cancer
7 WHI: Dietary Intervention Dietary Intervention Goals: Reduce dietary fat intake (target 20% calories from fat) increase vegetables and fruit servings (target 5/day) increase grains servings (target 6/day) Weight loss not an intervention target Diet Group: women given a fat gram goal by centrally trained, registered dieticians implementing a low fat eating plan 1, 2 Monitoring for all: 4-day food record (baseline), food frequency questionnaire (FFQ) (baseline, year 1 and q 3 years on rotation) Control Group: women received dietary guideline report and were not asked to make dietary changes Ritenbaugh, Patterson, Chlebowski, et al. Ann Epidemiol 2006; 13(9 suppl): S87-97 Tinker, Burrows, Henry, et al. Nutrition in Women s Health, 1996
8 Ritenbaugh, Patterson, Chlebowski, et al. Ann Epidemiol 2006; 13(9 suppl): S87-97 Tinker, Burrows, Henry, et al. Nutrition in Women s Health, 1996 Structure of the WHI Dietary Intervention CORE 18 group sessions Year 1 Baseline Quarterly maintenance sessions Year 2 and beyond End of DM Trial AUGMENTATIONS Motivational Interviewing 3 personal contacts Targeted Messaging Mailing Tailored Feedback: Personal Evaluation of Fat Intake Group sessions Tailored Feedback: Personal Evaluation of Fat Intake Mailing Clinical Center augmentations
9 Outcome Ascertainment Mammogram every 2 years (annually if also in a WHI hormone therapy trial) Breast cancer verified by medical record and pathology report review by WHI physician adjudicators at clinical centers with final adjudication and coding at the Clinical Coordinating Center (CCC) Cause of death determined at CCC by medical record or death certificate review Serial National Death Index queries, last 31 DEC 2011
10 Women s Health Initiative WHI Dietary Modification Trial 373,092 completed the eligibility screening form 56,139 eligible 48,835 randomized Intervention 19,541 Comparison 29,294 Dietary Prentice RL, Caan B, Chlebowski RT, et al JAMA 2006;295:629-42
11 Baseline Demographics of Participants in the WHI DM Trial did not differ by Randomization Age Race/ethnicity Breast cancer family history Gail 5y breast cancer risk Reproductive history Body Mass Index Mammogram within 2 years History of estrogen plus progestin use History of estrogen alone use Treated diabetes
12 Baseline Intakes by Randomization Group Category Diet Mean (SD) Control Mean (SD) P-value Calories from Fat (percent of total/d) Fruit and vegetable (servings/d, median) Grains (servings/d, median) 37.6% (4.96) 37.8% (5.0) (1.8) 3.6 (1.8) (2.5) 4.7 (2.4) 0.71 Similar intakes in randomization groups at baseline
13 Change in Dietary Intake and Body Weight (Baseline minus Year 1) by Randomization Group Change in Intake (Baseline Year 1) Diet mean (SD) Control mean (SD) P-value Calories from fat (percent of total/d) Fruit and vegetable (servings/d, median) Grains (servings/d, median) -13.9% (7.5) -2.5% (6.0) < (2.1) 0.2 (1.5) < (2.7) -0.5 (2.2) <0.001 Weight (kg) All target intakes -3.2 (9.2) significantly changed -0.1 (7.8) <0.001
14 At protocol defined end date, after 8.3 years follow-up (mean) JAMA 2006;295:
15 WHI Dietary Modification Trial: Breast Cancer Incidence by Treatment Group HR 0.91 ( ) 1,727 total diagnoses, p= % of all DM participants For breast cancer mortality 27 vs 53, HR 0.77 ( ) Prentice RL, Caan B, Chlebowski RT et al. JAMA 2006;395:629-42
16 Breast Cancer Characteristics of 1767 Cases by Randomization Group Characteristic Diet [N=672] N (%) Control [N=1095] N (%) P-Value 1 Histology 0.79 Ductal 435 (64.9) 711 (65.2) Lobular 64 (9.6) 98 (9.0) Ductal and lobular 84 (12.5) 151 (13.9) Other 87 (13.0) 130 (11.9) * P-values based on chi-squared tests of association Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
17 Breast Cancer Characteristics by Randomization Group Characteristic Diet [N=672] N (%) Control [N=1095] N (%) P-Value 1 Stage 0.74 Local 493 (74.8) 814 (75.5) Regional or distant 166 (25.2) 264 (24.5) Tumor size, cm 0.88 <1 170 (28.0) 305 (30.9) 1-<2 287 (47.3) 405 (41.0) > (24.7) 278 (28.1) Lymph node positive 0.99 None 450 (75.0) 170 (75.8) (18.7) 167 (17.1) (6.3) 69 (7.1) Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
18 Breast Cancer Characteristics by Randomization Group Characteristic Diet [N=672] N (%) Control [N=1095] N (%) P-Value 1 Estrogen Receptor 0.99 Positive 521 (83.9) 851 (83.9) Negative 100 (16.1) 163 (16.1) Progesterone Receptor 0.05 Positive 439 (71.6) 669 (67.0) Negative 174 (28.4) 329 (33.0) HER2 positive 90 (18.8) 134 (17.6) 0.61 Triple-negative 40 (8.5) 74 (9.9) 0.43 P-values based on chi-squared tests of association. Somewhat fewer PR negative cancers in the Diet group. Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
19 Background Dietary Fat Intake and Breast Cancer The Women s Health Initiative Dietary Modification (DM) Trial Study Design and Implementation Primary Breast Cancer Incidence Results (2006) Rationale for Secondary Analyses Current Results Deaths After Breast Cancer Deaths From Breast Cancer Breast Cancer Overall Survival
20 Low-Fat Dietary Pattern and Breast Cancer Mortality: Rationale for Secondary Analyses At the end of dietary intervention after 8.3 years, of 1767 invasive breast cancers, there were 8% fewer cases in the dietary group (HR 0.92, 95% CI , P=0.09) but no suggestion of a reduced incidence during post-intervention follow-up. In addition, during dietary intervention, deaths from breast cancer were non-significantly lower in the dietary group (HR % CI ). These findings suggested that dietary modification may reduce breast cancers associated with greater mortality and sustained dietary intervention is needed to maintain effect. Prentice, Caan, Chebowski, et al. JAMA 2006;295: Thomson, Van Horn, Caan, et al. Cancer Epidemiol Biomarker Prev 2014;23(12):
21 Outcome Measures Deaths from breast cancer (breast cancer followed by death attributed to the cancer) and Deaths after breast cancer (breast cancer followed by death from any cause) Breast cancer overall survival (survival from diagnosis with death from any cause) All outcomes based on breast cancers diagnosed during dietary intervention Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
22 Statistical Considerations Analyses of deaths from and after breast cancer during the dietary intervention period, includes all 48,835 study women measured from randomization. Analyses of breast cancer overall survival includes the 1767 women with breast cancer diagnosed during dietary intervention with follow-up through August 2014 measured from diagnosis. ITT analyses, stratified by age and WHI Hormone Therapy trial randomization status.
23 Flow of 48,835 Participants for Analysis of Deaths From and After Breast Cancer ( ) 48,835 randomized Intervention 19, withdrew 254 lost 672 breast cancer cases Comparison 29, withdrew 273 lost 1095 breast cancer cases 40 deaths after Dx 94 deaths after Dx 19,541 included in analysis 29,294 included in analysis 19,541 included in analysis 29,294 included in analysis Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
24 Low-Fat Dietary Pattern and Deaths from and after Breast Cancer During the Intervention Period HR(95% CI) = 0.68 (0.43, 1.07) P-value = 0.09 N = 88 total deaths Deaths from Breast Cancer HR(95% CI) = 0.65 (0.45, 0.94) P-value = 0.02 N =134 total deaths Deaths after Breast Cancer Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
25 Death after Breast Cancer: Exploratory Analyses PR Status and Weight Change Adjustment Variable Death after Breast Cancer HR (95% CI) P-value Time-dependent variables for PR negative and unknown 0.70 ( ) 0.06 Baseline weight and subsequent weight change 0.65 ( ) 0.02 PR status between randomization groups and diet group weight loss do not explain the death after breast cancer results Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
26 Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043 Flow of 1,767 Women with Incident Breast Cancer for Analysis of Breast Cancer Overall Survival ( ) 48,835 randomized Intervention 19, Breast Cancers Comparison 29, Breast Cancers Extended Follow-up to Sept deaths after Dx 319 deaths after Dx 672 included in analysis 1095 included in analysis 672 included in analysis 1095 included in analysis
27 Breast Cancer Therapy by Randomization Group Diet Control Radiation Therapy 79% 75% Endocrine Adjuvant 71% 68% Chemotherapy Adjuvant 32% 36% Breast cancer therapy directed by participants Health Care providers Self reported information available in a subset (675 of 1767) Therapy reflects relatively low stage disease found in this regularly screened population Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
28 Intake Change (Baseline minus after Breast Cancer) by Randomization Group Intake 1.6 years (mean) after breast cancer Calories from fat (percent of total) Fruit and vegetable (servings/d, median) Grains (servings/d, median) Diet Control P-value -9.5% -1.3% < < <0.001 FFQ after breast cancer diagnosis available in subset (n=1202) of 1767 women with breast cancer Dietary Group Participation Continued After Diagnosis Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
29 Breast Cancer Overall Survival for 1767 Women Diagnosed During the Dietary Intervention Period HR (95% CI) 0.80( ) P-value = 0.02 N = 487 total deaths 10 year survival 82% vs. 78% Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
30 Cause of Death in Women with Breast Cancer by Randomization Group Cause of death Diet Control HR (95% CI) All Cause ( ) Breast Cancer ( ) Other Cancer ( ) CVD ( ) Other* ( ) * Includes all cause vs other plus unknown Cause of death available in 400 of 487 breast cancer cases All cause mortality, P=.02 Interaction P-value, P=.14 Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
31 Linear Time Varying Hazard Ratio Breast Cancer Overall Survival Intervention Period HR(95% CI)=0.67( ) Post-intervention HR(95% CI)=0.85( ) Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
32 Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043 Linear Time Varying Hazard Ratio Breast Cancer Overall Survival Intervention Period HR(95% CI)=0.67( ) Post-intervention HR(95% CI)=0.85( ) The Grambsch and Therneau test provided evidence against proportionality during the intervention period.
33 Linear Time Varying Hazard Ratio Breast Cancer Overall Survival Intervention Period HR(95% CI)=0.67( ) Post-intervention HR(95% CI)=0.85( ) Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
34 Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043 Linear Time Varying Hazard Ratio Breast Cancer Overall Survival Intervention Period HR(95% CI)=0.67( ) Interaction p-value = 0.02 Post-intervention HR(95% CI)=0.85( ) P-value for trend=0.02 P-value for trend=0.45
35 Conclusions In a breast cancer prevention trial, adoption of a low-fat dietary pattern, Reduced deaths after breast cancer and Increased breast cancer overall survival Time-trend analyses suggest continued dietary intervention may be needed to maintain benefit. Chlebowski, Aragaki, Anderson, et al AACR 2016 Abst CT043
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