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Research in the Program for Young Women with Breast Cancer: Past, Present and Future

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An overview of research for young women with breast cancer. By
Shoshana Rosenberg, ScD and Ann H. Partridge, MD MPH
Dana-Farber Cancer Institute

Published in: Health & Medicine
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Research in the Program for Young Women with Breast Cancer: Past, Present and Future

  1. 1. Research in the Program for Young Women with Breast Cancer: Past, Present and Future Shoshana Rosenberg, ScD and Ann H. Partridge, MD MPH Dana-Farber Cancer Institute January 24, 2018
  2. 2. • In 2005, we established The Program for Young Women with Breast Cancer (“Young and Strong”) to address the unique issues facing the young patients at DFCI • The program addresses critical issues including:  Fertility  Genetics  Parenting  Sexual functioning  Psychosocial and Emotional Health  Exercise and Nutrition  Balancing School and/or a Career  Building Relationships • Initially, the program served women diagnosed at age 42 and younger but include women up to 45 now • To date: directly served over 4,000 new young patients visiting our breast oncology clinics
  3. 3. A Comprehensive and Integrated Program Focused on Young Women Clinical Care Research Education (both patient and provider)
  4. 4. Local therapy Genetics Endocrine therapy Chemotherapy Fertility Adherence Psychosocial functioning Sexual health Young age
  5. 5. Helping Ourselves, Helping Others: The Young Women’s Breast Cancer Study (YWS) Prospective cohort established in 2006 • Women age ≤40 at diagnosis of breast cancer • Eastern Massachusetts, Colorado, MN, Canada Outcomes • Disease, tumor biology/molecular characteristics • Treatment issues (surgical decisions, adherence) • Psycho-social (fertility, sexuality, workplace issues) • Lifestyle factors (alcohol, exercise, weight gain) • Health services (delay in diagnosis, survivorship care) Accrual • 1302 participants enrolled • Surveys: every 6 months x 3 years, annually thereafter • Blood: 91% of patients with at least one sample • Tumor: 98% consented, centrally reviewed by study pathologists, block banked for future research PI: Partridge Co-PI: Rosenberg
  6. 6. Participating Sites o Brigham and Women’s Hospital/DFCI o Faulkner Hospital o Massachusetts General Hospital o Beth Israel Deaconess Medical Center o South Shore Hospital o Mass General/North Shore Cancer Center o Cape Cod Healthcare o Lowell General Hospital o Newton Wellesley Hospital o Sunnybrook Health Sciences Center o University of Colorado – Denver o Mayo Clinic o Also, related studies on-going in Europe, Saudi Arabia, Israel
  7. 7. Recruitment • Inclusion Criteria • Female • New diagnosis of breast cancer (no history of breast cancer) • Stage 0-4 included but exclude pure LCIS • Age 40 or younger at diagnosis • Informed consent obtained from patient • Ability to understand written and spoken English to the extent necessary to complete the questionnaires • At Partners institutions, potentially eligible cases were identified from review of tumor registry lists • At some sites, research nurses and/or research coordinators assisted with recruitment via review of patient lists
  8. 8. Study/Survey timeline All surveys are sent based on patients’date of diagnosis, except the baseline and 6 month surveys Consent Survey 1 Blood sample Survey 2 Survey 3 Blood sample Survey 4 Med Rec Request Tissue Request Survey 5 Survey 6 3 year 20 year = annual surveys 4 year = final blood sample 7, 10 year = LTF Re- engagement Baseline 6 mos 1 yr 18 mos 2 yrs 30 mos 3 20 yrs
  9. 9. Some examples of survey measures • Socio-demographics • Medical and family history • Genetics • Fertility issues and outcomes • General quality of life • Anxiety and depression • Menopausal symptoms • Physical activity
  10. 10. Timepoint Range Baseline Enrollment – 9 months post diagnosis 1 Year 9 months – 2 years post diagnosis 4 year 3.5 years – 5 years post diagnosis Blood Specimen Collection • We work with coordinators at participating sites to arrange these draws or we send blood kits directly to the patients with appointments offsite • We process these specimens and isolate whole blood + plasma before freezing them for future studies • 1224/1302 =94% women have consented to blood • Of these, >90% have contributed at least one sample
  11. 11. Tissue Specimen Collection • We collect specimens to characterize the tumors and bank for future studies utilizing: • molecular evaluations of disease characteristics (via TMA) • genetic variability (via whole exome sequencing) • 1278/1302=98% have consented to pathology specimen collection • Of these, >80% have undergone pathology review
  12. 12. Overview of selected completed/ Ongoing studies • Pathologic features and biology of breast cancer in young women • Health care delivery • Local therapy and patient decision making • Fertility and pregnancy issues • Psycho-social and quality of life issues
  13. 13. Pathologic features/molecular phenotype • Pathologic features and molecular phenotype by patient age in a large cohort of young women with breast cancer • Molecular Phenotype of Breast Cancer According to Time Since Last Pregnancy in a Large Cohort of Young Women
  14. 14. Collins et al. BCRT 2012 • N=399 women • No differences in clinico-pathologic phenotype by age • 35% were luminal B
  15. 15. Collins et al. The Oncologist 2015 • N=707 women • No association with parity or recency of pregnancy and molecular phenotype, adjusting for age at diagnosis and family history
  16. 16. Health care delivery • Breast cancer presentation and diagnostic delays in young women • BRCA1 and BRCA2 mutation testing in young women with breast cancer
  17. 17. Ruddy et al. Cancer 2014
  18. 18. Rosenberg et al. JAMA Onc 2016
  19. 19. • Perceptions, knowledge, and satisfaction with contralateral prophylactic mastectomy among young women with breast cancer: a cross-sectional survey • Local therapy decision-making and contralateral prophylactic mastectomy in young women with early-stage breast cancer Local therapy
  20. 20. • 123 women with unilateral breast cancer, age 40 or younger at diagnosis who had undergone bilateral mastectomy • ~25% BRCA 1 or BRCA 2 mutation carriers • Median time since surgery: 2.1 (range: 0.1-4.3) years • Median age at diagnosis: 37 (26-40) years • 79% Stage I/II at diagnosis
  21. 21. Rosenberg et al. Ann Intern Med 2013 Reasonsfor choosingCPM
  22. 22. • 560 women with Stage I-III unilateral breast cancer enrolled in YWS • Characterization of decision-making process, including involvement and confidence with the decision • Assessment of socio-demographic, clinical and decisional factors associated with CPM vs. breast conserving surgery and unilateral mastectomy
  23. 23. Decisional involvement Rosenberg et al. Ann Surg Onc 2015
  24. 24. Local therapy decision-making and CPM in young women with early-stage breast cancer Rosenberg et al. Ann Surg Onc 2015 • Among women where BCS was an option or was recommended, choosing CPM (vs. other types of surgery) was associated with: • Testing positive for a BRCA mutation • Higher levels of generalized anxiety • Lower BMI • Lower levels of fear of recurrence
  25. 25. Fertility is a primary issue Ruddy et al, J Clin Oncol, 2014
  26. 26. Enrolled in YWS, n=1302 Completed abbreviated surveys, n=137 No baseline survey, n=89 YWS: fertility outcomes Analytic cohort, n=1076
  27. 27. Patient, disease, treatment characteristics Characteristic Patients (n=1076) Age at diagnosis n (%) ≤30 years (yr) 140 (13) 31-35 years 293 (27) 36 – 40 years 643 (60) Stage 0 88 (8) I 355 (33) II 422 (40) III 145 (14) IV 56 (5) Partnered at diagnosis Yes 806 (75) No 263 (25) Children prior to diagnosis Yes 691 (64) No 385 (36) Phenotype ER+ 772 (72) ER- 293 (28) Adjuvant endocrine therapy Yes 704 (65) No 372 (35) Chemotherapy Yes 802 (75) No 270 (25) Median follow-up: 5 years
  28. 28. 38% 26% 27% 24% 24% 20% 15% 14% 13% 11% 7% 7% 0% 10% 20% 30% 40% 50% Interest in future biologic children n=1076
  29. 29. Fertility preservation use 79 29 1 34 1 10 0 10 20 30 40 50 60 70 80 90 Embryo cryopreservation Oocyte cryopreservation Ovarian tissue cryopreseration GnRH agonist OCPs Other Numberofpatients * 133/1206 (11%) patients took steps to preserve fertility prior to treatment OCPs=oral contraceptive pills
  30. 30. 87% 70% 64% 13% 30% 36% 0% 20% 40% 60% 80% 100% ≤30 years 31-35 years 36 – 40 years No TRA TRA No amenorrhea Amenorrhea 100% 60% 0% 40% 0% 20% 40% 60% 80% 100% No chemotherapy Chemotherapy No TRA TRA No amenorrhea Amenorrhea n=69 n=128 n=310 n=111 n=396 76% 64% 24% 36% 0% 20% 40% 60% 80% No tamoxifen Tamoxifen No TRA TRA No amenorrhea Amenorrhea n=188 n=319 Amenorrhea varies by age and use of chemotherapy and tamoxifen Poorvu et al, ASCO, 2015
  31. 31. Total cohort, n=1076 Interested, n= 387 (36%) Not interested, n= 689 (64%) Cumulative pregnancy interest, attempts, and outcomes  Excluded pregnancies occurring at time of diagnosis
  32. 32. Total cohort, n=1076 Attempted, n= 138 (36%) Interested, n= 387 (36%) No attempt, n= 249 (64%) Not interested, n= 689 (64%) Attempted, n= 8 (1%) No attempt, n= 681 (99%) Cumulative pregnancy interest, attempts, and outcomes  Excluded pregnancies occurring at time of diagnosis
  33. 33. Total cohort, n=1076 Attempted, n= 138 (36%) Interested, n= 387 (36%) Pregnant, n= 13 (5%) Not pregnant, n= 236 (95%) No attempt, n= 249 (64%) Pregnant, n= 1 (13%) Not pregnant, n= 7 (87%)Not interested, n= 689 (64%) Pregnant, n= 9 (1%) Not pregnant, n= 672 (99%) Pregnant, n= 94 (68%) Not pregnant, n= 44 (32%) Attempted, n= 8 (1%) No attempt, n= 681 (99%) Cumulative pregnancy interest, attempts, and outcomes  Excluded pregnancies occurring at time of diagnosis
  34. 34. Total cohort, n=1076 Attempted, n= 138 (36%) Interested, n= 387 (36%) Pregnant, n= 13 (5%) Not pregnant, n= 236 (95%) No attempt, n= 249 (64%) Pregnant, n= 1 (13%) Not pregnant, n= 7 (87%)Not interested, n= 689 (64%) Pregnant, n= 9 (1%) Not pregnant, n= 672 (99%) Pregnant, n= 94 (68%) Not pregnant, n= 44 (32%) Attempted, n= 8 (1%) No attempt, n= 681 (99%) Cumulative pregnancy interest, attempts, and outcomes  Excluded pregnancies occurring at time of diagnosis
  35. 35. Live births, 108, 61% Micarriages, 44, 25% Abortions, 7, 4% Stillbirths, 2, 1% TBD, 15, 9% 173 pregnancies among 117 women (including 3 sets of twins) Median f/u: 5 years Pregnancy outcomes
  36. 36. Psycho-social and Quality of Life • Body image • Body image in recently diagnosed young women with early breast cancer • Sexual functioning • Treatment-related amenorrhea and sexual functioning in young breast cancer survivors • Anxiety/Depression • Partner support and anxiety in young women with breast cancer • Depression and anxiety symptoms in young women with metastatic disease
  37. 37. • Local therapy and QOL • Breast-Q (Dominici/Rosenberg) • Longitudinal analysis of QOL outcomes by surgery type (Rosenberg) • Adjuvant systemic therapy • Endocrine therapy adherence (Wassermann) • Endocrine therapy initiation and persistence (Rosenberg) • Psychosocial • Post-traumatic stress disorder (Vazquez, HMS) • Trajectories in sexual function (von Hippel, HSPH) • Experience of partners of young women with breast cancer (Borstelmann) Ongoing projects
  38. 38. Partner sub-study • One-time cross-sectional survey of partners of cohort participants • Outcomes included social support, quality of life, coping, parenting concerns, anxiety, depression, post- traumatic growth, sexual satisfaction • N=332 respondents • Almost all respondents were male • In women not in “active treatment,” median follow-up from (patient) diagnosis to survey of partner was 58 months
  39. 39. Concern N (%) Missing N Anxiety (HADS subscore ≥8) 106 (42) 39 Depression (HADS subscore ≥8) 47 (21) 60 Parenting concerns (N=208 with children) 74 (36) 4 Relationship strain 89 (32) 12 Financial insecurity 79 (29) 17 Not sexually active 55 (20) 12 Maladaptive coping style 120 (44) 19 Social support (MOS-SS summary score) Median (range) 67 (19-95) 15 Table 2. Prevalence of psychosocial concerns in partners (N=289) Abbreviations: HADS, Hospital Anxiety and Depression Scale; MOS-SS, Medical Outcomes Survey-Social Support Survey • Many partners of breast cancer survivors experience substantial psychosocial distress • In an analysis of factors associated with anxiety, maladaptive coping during treatment was associated with higher levels of anxiety • Attention to the psycho-social health of caregivers is critical during both the treatment and survivorship phases of care
  40. 40. • Biology • Understanding the genomic underpinnings of breast cancer in young women (Wagle) • ctDNA to identify MRD and risk of recurrence in young women (Parsons) • Whole Exome Sequencing of Treatment Resistant HER2+ Breast Cancer (Wagle/Waks) • Whole Exome Sequencing of Triple Negative Breast Cancer (Stover) Ongoing projects
  41. 41. PATHWAYS TO WELLNESS STUDY Improving Outcomes for Younger Breast Cancer Survivors: A randomized trial comparing outcomes for women receiving a mindfulness awareness practice group intervention, a health education curriculum tailored to younger women, or a delayed intervention control condition PIs: Ganz and Bower • Based on successful randomized pilot data from a single site pilot randomized trial at UCLA • 3 arm, multi-center RCT evaluating mindfulness vs. ed. vs. control • 6 week intervention teaching mindfulness awareness practices (MAPs) • Sitting and walking meditations • Application to physical symptoms, emotions, and thoughts • Focus on relevance for cancer survivorship
  42. 42. Study Outcomes: Post-treatment • Psychological: • Perceived stress, depression, anxiety • Symptoms: • Fatigue, sleep, pain • Health behaviors: • Stress-related eating, physical activity • Biological: • Inflammation, insulin, glucose • Heart rate variability • Reactivity to challenge
  43. 43. Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE Breast Cancer IBCSG 48-14 / BIG 8-13 ALLIANCE # A221405 POSITIVE TRIAL INTERNATIONAL PI: OLIVIA PAGANI NORTH AMERICAN PI: ANN PARTRIDGE
  44. 44. The POSITIVE Trial: Endocrine therapy interruption for pregnancy in breast cancer patients • Phase II trial designed to evaluate safety and pregnancy outcomes of interrupting ET for young women with ER+ disease who desire pregnancy • Enroll 512 women, <42, premenopausal, have completed between 18-30 months of ET • Study participants come off endocrine therapy for up to 2 years for a pregnancy attempt, restart hormonal therapy • Outcomes: disease, reproductive, psychosocial
  45. 45. YWS2: from observation to intervention Diagnosis Treatment Long-term Survivorship Enrollment Surgical DA Mindfulness intervention Symptom management to improve ET adherence 6 mo 12 mo Addressing menopausal sx, sexual dysfunction Expanding TS/SCP+ research pilot
  46. 46. Thank you! DFCI/YWS Team Ann Partridge, PI Shoshana Rosenberg, co-PI Eric Winer Rulla Tamimi Laura Collins Katie Ruddy Judy Garber Nick Wagle Lidia Schapira Jeff Peppercorn Elana Brachtel Steve Come Ginger Borges Ellen Warner Shari Gelber Phil Poorvu The Program for Young Women Team Kim Sprunck-Harrild Craig Snow Allison Higgins Rachel Gaither Sarah Walsh Eric Brosnan Megan Meyer Sonja Darai Stephanie Cram Sylvia Ilahuka
  47. 47. Thank you! CDC-DP 14-408
  48. 48. Thank you! All of the advocates, patients, and partners who have given their time and participated in our research
  49. 49. QUESTIONS?

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