Principal Investigator: Lawrence H. Kushi, ScD Project Manager: Janise M. Kim Roh, MSW, MPH. Funded by the National Cancer Institute (R01 CA105274)

Transcription

1 Principal Investigator: Lawrence H. Kushi, ScD Project Manager: Janise M. Kim Roh, MSW, MPH Funded by the National Cancer Institute (R01 CA105274) Kaiser Permanente Research

2 Background 3.1 million breast cancer survivors in the United States Lack of information on how non-clinical factors may influence breast cancer prognosis World Cancer Research Fund s recent systematic review of the literature on food, nutrition and physical activity in breast cancer prognosis recommended: More and better scientific research is needed in order to make specific recommendations for breast cancer survivors. Few studies on the impact of neighborhood and contextual level characteristics on prognosis 2 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

3 Study Objectives Investigate the effects of lifestyle, contextual, and molecular factors on breast cancer prognosis. Focusing on Post-diagnosis lifestyle factors including diet, physical activity, and complementary and alternative medicine (CAM) Social and built environment characteristics Molecular and genetic factors, including tumor DNA methylation profiles, inflammatory markers, and vitamin D levels 3 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

4 The Setting: Kaiser Permanente One of the oldest and largest integrated health care delivery systems in the United States Provides health care to approximately 3.5 million members throughout Northern California About 30% of the population residing in the counties in which KPNC has a physical presence are members of KPNC 4 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

5 KPNC Service Area 5 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

6 Data Resources at Kaiser Permanente Completely electronic health record since 2004 from Epic Systems (Verona, WI) branded as KP HealthConnect TM Legacy databases from the mid-1990s with documentation of clinical encounters and prescription medications KPNC Cancer Registry: reports to the Bay Area and State of California Surveillance, Epidemiology, and End Results (SEER) Cancer Registries 6 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

7 Pathways Study: A Collaboration Roswell Park Cancer Institute, Buffalo, NY Genetic and molecular factors Site PI: Christine Ambrosone, PhD Cancer Prevention Institute of California, Fremont, CA Social and contextual factors Site PI: Scarlett Lin Gomez, PhD University of California, San Francisco Tumor DNA methylation Site PI: John Wiencke, PhD Zero Breast Cancer, San Rafael, CA Community perspectives Site PI: Janice Barlow, BSN, NP 7 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

8 Eligibility Kaiser Permanente Northern California member Recent diagnosis of invasive breast cancer (AJCC Stages I-IV) At least 21 years old No previous history of malignant cancer English, Spanish, Mandarin, or Cantonese speaking Live within a 65-mile radius of a Pathways Study field interviewer 8 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

9 Recruitment Rapid case ascertainment via daily query of KPNC pathology databases Recruitment period: January 2006 through May 2013 Mean time from date of diagnosis to enrollment: 2.1 months Eligible Participants based on Electronic Pathology and Clinical Records 10,897 (100%) Letter Sent or Contacted Us 10,835 (99%) Appointment Scheduled 4,924 (45%) ENROLLED 4,505 (91%) Doctor Refused 62 (1%) Refused or Ineligible 5,911 (55%) Not Enrolled 419 (9%) 9 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

10 Study Enrollment by Race/Ethnicity and Age at Diagnosis (n, %) Asian Black White Hispani c Other Total Age group (y) < (38.6) 92 (25.7) 450 (15.5) 196 (35.2) 31 (26.3) 992 (22.0) (33.9) 128 (35.8) 797 (27.5) 170 (30.5) 30 (25.4) 1,321 (29.3) (20.1) 91 (25.4) 941 (32.5) 110 (19.7) 36 (30.5) 1,294 (28.7) (7.4) 47 (13.1) 706 (24.4) 81 (14.5) 21 (17.8) 898 (19.9) Total 578 (12.8) 358 (7.9) 2,894 (64.2) 557 (12.4) 118 (2.6) 4, April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

11 Study Enrollment by Race/Ethnicity and Body Mass Index (n, %) Asian Black White Hispanic Other Total Body Mass Index (kg/m 2 ) < (2.4) 0 (0.0) 29 (1.0) 3 (0.5) 1 (0.8) 47 (1.0) (50.7) 55 (15.4) 941 (32.5) 136 (24.4) 30 (25.4) 1,455 (32.3) (32.7) 88 (24.6) 919 (31.8) 191 (34.3) 36 (30.5) 1,423 (31.6) (9.3) 94 (26.3) 548 (18.9) 119 (21.4) 26 (22.0) 841 (18.7) (4.8) 121 (33.8) 456 (15.8) 108 (19.4) 25 (21.2) 738 (16.4) Total 578 (12.8) 358 (7.9) 2,894 (64.2) 557 (12.4) 118 (2.6) 4, April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

12 Selected Cohort Characteristics Distribution of AJCC Stage by Race/Ethnicity Stage I Stage II Stage III Stage IV Asian Black White Hispanic Other 12 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

13 Selected Cohort Characteristics Receptor Status by Race/Ethnicity Asian Black White Hispanic Other ER+ Triple Negative Status 13 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

14 Data Collection Timeline and Domains BL 14 April 30, Kaiser Foundation Health Plan, Inc. For internal use only. 6 Mo 12 Mo 24 Mo 48 Mo 72 Mo 96 Mo Demographics, Health History x Medical Conditions/Health Issues (Self-Reported) x x x x x Recurrence/New Cancers (Self-Reported) x x x x x Vitamins and Supplements x x x x Complementary and Alternative Medicine (CAM) x x x x Diet (including organic foods) x x x x Physical Activity x x x x Lymphedema x x x x Neighborhood Characteristics x Quality of Life & Psychosocial Measures x x x x Anthropometry Measures x x x x

15 Biorepository at RPCI Overall Collected Not Collected Blood 4,034 (89.5%) 388 (10.9%) Saliva 4,310 (95.7%) 195 (4.3%) Per Subject Blood Storage container Aliquot volume (ml) No. of aliquots Total volume (ml) Storage Temperature ( o C) Whole blood Cryovials Clot Cryovials Red cells Cryovials CBS Straws Plasma CBS Straws Serum CBS Straws Buffy coat CBS Straws Cryovials 0.5 as available -80 Saliva Oragene kit Room 15 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

16 Outcomes Ascertainment Self-Report from Questionnaires Report from Family Members KPNC Cancer Registry KPNC Mortality File Electronic Medical Record All potential outcomes confirmed via medical records review 16 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

17 Outcomes, as of December 31, 2014 (n, %) Breast Cancer Recurrence 369 (8.2) Second Primary Cancer 213 (4.7) Deaths 469 (10.4) Deaths due to Breast Cancer 214 (4.8) Breast Cancer-Free Survival* 483 (10.7) Invasive Disease-Free Survival 751 (16.7) Total recurrence, contralateral second primary invasive breast cancer (excludes new primary DCIS), or breast cancer death Total recurrence, invasive second primary cancer (excludes new primary DCIS), or total deaths 17 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

18 Preliminary Outcome Analyses Variable Race/Ethnicity (ref=white) 18 April 30, Kaiser Foundation Health Plan, Inc. For internal use only. Recurrence (n=369) Death (n=469) HR 95% CI HR 95% CI African American Hispanic Asian AJCC Stage (ref=i) II III IV ER status (ref=positive) negative Age-adjusted proportional hazards models

19 Preliminary Outcome Analyses Variable Recurrence (n=369) Death (n=469) HR 95% CI HR 95% CI BMI (ref= kg/m 2 ) < Age-adjusted proportional hazards models 19 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

20 Preliminary Outcome Analyses Variable Recurrence (n=369) Death (n=469) HR 95% CI HR 95% CI Total physical activity, MET-hrs/week (ref=low) medium high Moderate-vigorous activity, MET-hrs/week (ref=low) medium high Age-adjusted proportional hazards models 20 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

21 Pathways Ancillary Studies Racial Disparities in the Initiation and Intensity of Adjuvant Therapy for Breast Cancer (DOD BC043120; Pl: Al Neugut, Columbia University) Natural History and Cost Analysis of Lymphedema Secondary to Breast Cancer (ACS RSG LR; PI: Marilyn Kwan, KPNC) Using Physiological Age to Predict Chemotherapy Toxicity (R01 CA124924; PI: Jeanne Mandelblatt, Georgetown University) Adjuvant Breast Cancer Therapies: Race, Variations in Care and Survival (ACS RSGT , PI: Dawn Hershman, Columbia University) Lifestyle and Molecular Factors of Bone Health in Breast Cancer Survivors (R01 CA166701; Multiple PIs: Marilyn Kwan, KPNC, and Song Yao, Roswell Park Cancer Institute) 21 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

22 Next Steps Continue to build the Pathways Study resource Cohort follow-up through 96 months and annually thereafter Collect follow-up blood samples Obtain and store tumor specimens Linkage with contextual databases 22 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

23 Acknowledgements Principal Investigator Lawrence H. Kushi, ScD Co-Investigators Marilyn L. Kwan, PhD Lou Fehrenbacher, MD Susan Kutner, MD Bette Caan, DrPH Charles Quesenberry, PhD Barbara Sternfeld, PhD Carol Somkin, PhD Roswell Park Cancer Institute Christine Ambrosone, PhD Song Yao, PhD Chi-Chen Hong, PhD Cancer Prevention Institute of California Scarlett Lin Gomez, PhD Peggy Reynolds, PhD Theresa Keegan, PhD Salma Shariff-Marco, PhD University of California, San Francisco John Wiencke, PhD Shichun Zheng, MD Zero Breast Cancer Janise Barlow, BSN, NP Catherine Thomsen, MPH Research Team Isaac Ergas, MPH Cecile Laurent, MA Valerie Lee, MSPH Julie Munneke Judy Jensen Adriana Martinez Elinette Nicolas Julie Pham Virginia Pozo Claudia Samayoa Veronica Ting All Pathways Study participants 23 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.

24 Thank You! 24 April 30, Kaiser Foundation Health Plan, Inc. For internal use only.