Sunnybrook/TSRCC Breast Program Strategic Planning Retreat

1. Sunnybrook/TSRCC Breast ProgramStrategic Planning Retreat April 23, 2007

2. Breast Cancer: State of the Union • What has changed? • What will change ?

3. Breast Cancer in Canada • Most common malignancy affecting women in 2002 in Canada • 20,500 diagnosed • 5,400 died • Incidence rates have leveled over last 10 years • Mortality rates have dropped by 25% in last 20 years

4. Preventive Oncology: Key changes in the last 5 years • Increased demand for and utilization of genetic services for assessment of hereditary predisposition • Increased evidence to support risk reduction interventions in patients with hereditary predisposition to breast cancer • Chemoprevention of breast cancer • ?Research vs. standard of care • Clarification of Breast Cancer Risk Factors • e.g. HRT • Development of a provincial cancer prevention strategy • “Cancer 2020”

5. Preventive Oncology: What can we expect in the next 5 years? • More complex genetic assessment • More genes, more sophisticated testing • More prevention studies • More accountability re: provincial targets/CSQI • More cancer • NOT more funding • MRI screening

6. MRI Screening in Canada • Currently being performed in a few large centres and a few private clinics • National Hereditary Taskforce Guidelines (Jan/07): Annual mammography should be supplemented by MRI where it is available. • Ontario PEBC Guideline in final stages. Like ACS but: • 25% lifetime risk • Includes some patients with LCIS / atypia • Aim to bring MRI screening under umbrella of OBSP to ensure: • Minimum standards are met by all centres • Access for all women who might benefit • Outcome analysis and CQI

7. Imaging: Key changes in the last 5 years • Increasing volume • US & MRI • Increasing interventions • Core & vacuum assisted biopsies – expense • Digital mammography • Choice of residents for teaching • Clinical research – CAD • DMIST • ACRIN 6666 Screening Ultrasound • MRI high risk screening • CEDM & DBT

8. Imaging: What can we expect in the next 5 years? • Screening & increasing diagnostic volume & interventions • OBSP – screening & assessment centre • Conversion to all digital imaging • Timely diagnosis • Research – MRI • Contrast –enhanced digital mammography • Digital Breast Tomosynthesis • CE DBT

9. Surgical Oncology: Key changes in the last 5 years • More emphasis on “minimally invasive” surgery • Importance of breast imaging for surgical decision-making • Importance of multidisciplinary care • Critical mass of breast surgeons at TSRCC

10. Surgical Oncology: What can we expect in the next 5 years? • Increased emphasis on neoadjuvant treatments • Greater reliance on imaging (MRI as standard?) • Greater multidisciplinary care • More resources/patient • Better coordination of services/streamlining of appts needed • Consumer demand for patient-focused services • The challenge of maintaining referral base • Patient navigation • Admin support • Efficient triage and follow-up services

11. Pathology: Key changes in the last 5 years •  screen detected breast lesions • Difficult to assess borderline lesions •  # of non-palpable breast lesions • More volume to process • Development of new biological markers and their adoption as standard of care • Impact on HR, pathology & lab budget • Pathology has become an integral part of clinical multidisciplinary teams (HR) • Pathology is a key player in breast cancer research (HR)

12. Pathology : What can we expect in the next 5 years? •  volume •  discovery of new biological markers, both as prognostic and predictive markers • New molecular / genetic classification • Molecular finger printing of breast cancer • Increased use of image analysis for marker assessment • Identification of stem cell markers

13. Radiation Oncology: Key changes in the last 5 years Infiltrating Ductal Carcinoma • The Expanding Role of XRT • Increasing use of Locoregional XRT • Improved Techniques of XRT • Intensity-Modulated Radiation Therapy less toxicity • Boost for women < 50 years old • Partial breast radiation (Brachytherapy) • Reducing the Toxicity of XRT • Cardiac toxicity • IMRT leads to less scatter Ductal Carcinoma in Situ • Increasing incidence • Increasing evidence of benefit of XRT • Increasing concerns of under treatment and potential over treatment

14. Radiation Oncology : What can we expect in the next 5 years? • Early Stage Breast Cancer • Partial breast irradiation (external beam/brachytherapy/IORT) • Image guidance and Adaptive Radiotherapy • Is bolus necessary? • Locally Advanced Breast Cancer • Combined modality therapy • Increased intensity of treatment with reduced treatment time • Imaging for the evaluation of treatment response (US, PET, MRI) • DCIS • Identify factors predictive of invasive recurrence • Improved Risk Stratification • Lumpectomy /Lumpectomy + XRT / Mastectomy • Improve XRT Techniques • Partial breast irradiation • Role of boost for young women

15. Medical Oncology: Key changes in the last 5 years • Expanded indications for adjuvant chemotherapy • Node negative, HER2 positive • Dose-dense chemo • Use of G-CSRF, erythropoetin • Use of adjuvant taxanes • Increased use of neo-adjuvant therapy • AI’s in adjuvant therapy • Length of adjuvant endocrine therapy • Wide use of bisphosphonates • Use of biologics • Herception – met//adjuvant • Lapatinib

16. Medical Oncology: What can we expect in the next 5 years? • New tests for prediction • Oncotype DX • Other molecular signatures • Use of biologics in adjuvant therapy • Use of adjuvant chemotherapy • Drugs for metastatic disease • Fewer patients with metastatic disease

17. Survivorship: What has changed in the last 5 years? • Awareness of survivorship issues • Length of endocrine adjuvant therapy • More survivors for longer • Issues of • QOL • Exercise, body and weight • Other lifestyle issues

18. Survivorship : What will change in the next 5 years? • Extended endocrine adjuvant therapy • Focus on lifestyle issues • Biologics and their long term effects

19. Palliative Care: Key changes in the last 5 years • Expanding role in the care of patients prior to end-of-life • Clinical expertise in the management of symptoms associated with breast cancer: lymphedema, brachial plexopathy, complex neuropathic/bony mets pain syndromes

20. Palliative Care: What can we expect in the next 5 years? • As the research base within the field of palliative medicine expands, greater body of evidence for targeted and individualized pain and symptom management interventions • Expanding role for interventional pain management procedures: nerve blocks • Ongoing source of care and support for patients with disease progression

21. Care Delivery Models: Key changes in the last 5 years • Screening Programs (OBSP) • Diagnostic Assessment Units • Multidisciplinary Programs • Survivorship Programs

22. Diagnostic Assessment Units • Completing diagnostic evaluation in a streamlined, comprehensive and timely manner • Principles • Patient-focused • Multidisciplinary • Timely • Components • Triage mechanism • Breast imaging: mammography, US, biopsy, MRI • Clinical assessment • Patient Navigator

23. Diagnostic Assessment Unit : What might it look like? • Triage referrals • Imaging • Screening or diagnostic • Clinic • Surgical or nonsurgical • Streamlined diagnostic imaging • All diagnostic studies (except MRI) same day • MRI and MRI-generated FU studies same day • Rapid turnaround of pathology • Prompt clinic appt after diagnostic evaluation • Patient navigation/nursing support

24. Breast cancer : Summary of Key changes in the last 5 years • Improved and expanded screening and early diagnosis • Reduced mortality rates • Reduced or stable incidence rates • Increased use of imaging • Use of sentinel node • More breast conserving surgery • New radiation approaches • Improved adjuvant endocrine therapy • New adjuvant chemotherapy • Biologics

25. Breast Cancer : Key changes in the next 5 years • New approaches to surgery • Image-guidance • New approaches to radiation • Image-guidance • New approaches to systemic therapy • Especially biologics • Lifestyle approaches for survivors • More survivors for longer

26. What Do Women Want? In-depth interviews with: • Health care providers • Former patients • Informal caregivers • Telephone survey of 800 women without cancer • Cancer professionals

27. The Problem Lack of coordination of care Gaps in communication between health care providers Lack of psycho-social support with the shock of the diagnosis Lack of information: Feeling “numb and dumb” at time of critical treatment decision-making Provider knowledge “Many participants expressed disappointment with the breast cancer knowledge of their primary care providers” Executive Summary

28. The Problem Lack of coordination of care Gaps in communication between health care providers Lack of psycho-social support with the shock of the diagnosis Lack of information: Feeling “numb and dumb” at time of critical treatment decision-making Provider knowledge “Many participants expressed disappointment with the breast cancer knowledge of their primary care providers” The Potential Solution Navigator ? Multidisciplinary care ? Increased Psychosocial support Educational websites? Brochures? DVDs? Well follow-up clinics? Executive Summary

29. What Could Make Treatment for Breast Cancer a “Wonderful Experience?” • Informed Participation • Emotional Support • Timeliness

30. Breast Cancer at TSRCC/Sunnybrook

31. Breast Cancer at TSRCC • One of 2 largest breast programs in Canada • One of 6 or 8 largest breast programs in North America • Primary nursing model • Multidisciplinary care • Interdisciplinary care • Strong emphasis on research/teaching • Volumes Surgery volumes Radiation volumes Medical Oncology volumes See handout in package for breast activity at TSRCC

32. Breast Site Group at TSRCC • 17 Medical Oncologists • 16 Radiation Oncologists • 4 Surgeons • 3 (4) Specialist pathologists • 2 (3) Specialist diagnostic imagers • 15 RNs • Social workers • Dietitians • Pharmacists • Physicists • Radiation therapists • Genetic counselors

33. Accomplishments

34. Honors and Awards • Prominent Role in NCIC/CTG – Breast Group • Prominent Role in OCOG Breast Group • Fellowship Program • Campbell Endowed Fellowship • Industry Fellowships • CAMO Fellows • CBCF Fellows • CFI Awards • 11.2 x 106$ for Breast Centre • Breast Centre – 27 million dollars • As a primary fundraising target SHSC

35. Honours and Awards (cont’d) • Grants: • Dr. Eileen Rakovitch – largest CBCRA grant 2007, 5 years • Dr. Arun Seth • CBCRA 2005-2010 Metastatic “Breast Cancer Genome Anatomy” $ 610,000 • CBCRA (Grant Core Component) 2005-2010 “New Approaches to Metastatic Disease in Breast Cancer (METS)” $ 969,067 • NIH, USA 2007-2012 The BCA2 Ubiquitin E3 Ligase as a Target in Breast Cancer $1,759,000 USD

36. Honours and Awards (cont’d) • Grants: • Dr. Greg Czarnota • 2 OICR grants ~$300,000 • CBCF $428, 000 • Drs. Yaffe/Plewes – Terry Fox Grant • Dr. Claire Holloway and others • OCRN grant ~ $300,000 • Plenary Session at ASTRO – Dr. Jean-Philippe Pignol • O.H. Warwick Award - Dr. Kathleen I. Pritchard, 2005

37. Landmark Papers • Warner E. et al. Surveillance of BRCA1 and BRCA2 Mutation Carriers With Magnetic Resonance Imaging, Ultrasound, Mammography, and Clinical Breast Examination. JAMA. 2004; 292:1317-1325 • Yaffe, M. et al. Diagnostic Performance of Digital versus Film Mammography for Breast-Cancer Screening. New England Journal of Medicine, Volume 353:1773-1783 October 27, 2005 Number 17 • Pritchard, K.I. et al. HER2 and Responsiveness of Breast Cancer to Adjuvant Chemotherapy. New England Journal of Medicine, Volume 354: 2103-11, May 18, 2006 Number 26 • Seth, A.K. et al. A Novel RING-Type Ubiquitin Ligase Breast Cancer-Associated Gene 2 Correlates with Outcome in Invasive Breast Cancer. American Association for Cancer Research.

38. Prevention: Accomplishments • Comprehensive assessment of genetic and cancer risk • Accrual to chemoprevention studies • Follow-up of high risk women • Participation in collaborative research • Education/training • Regional role

39. Surgery:Accomplishments • Establishment of an academic program in breast surgery • Fellowship training program • Critical mass of academic surgeons • Standardized multi- and interdisciplinary care • Integrated research program • Multidisciplinary • Partnerships with U of T, ICES, CCO • Surgical representation at provincial, national organizations • Grants • Imaging and histopathology correlation after neo-adjuvant chemotherapy (CBCF) • Radioimmunoguided surgery (OCRN) • Evaluating the quality of sentinel lymph node biopsy quality in Ontario (CBCF) • Patterns of breast cancer surgery in Ontario (CCO)

40. Pathology : Accomplishments • Sign-out of breast cases by dedicated specialized pathologists • Adoption of synoptic reporting • Testing for ER/PR and Her2/neu on all patients at the time of diagnosis • Improving TAT. In general, only 10% of cases are >10 days for the whole department (all specimen types) • Leader for setting provincial and national Her2 testing guidelines and QA program • Established TMA facility

41. Pathology : Accomplishments Academic achievements: a) Grants b) CME activities c) Tumour Boards d) Regular clinicopathological rounds weekly e) Member of expert panel and publication of CAP/ASCO guidelines (Wolff AC, Hammond EH, Schwartz JN. Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. J Clin Oncol 2007;25(1):1-28.) f) Tumour Banking initiative (old & new)

42. Radiation Oncology: Accomplishments • Prevention / Screening • Population-based assessments of screening • Treatment • Development of a Permanent Breast Seed implant • PI of randomized clinical trial on Breast IMRT • Plenary Session at ASTRO • Development of international bone metastases module to accompany the EORTC QLQ-C30 for patients with bone metastases. • PI on International RCT of Single versus Multiple Fractions for Re-Irradiation of Painful Bony Metastases – NCIC SC 20 • Chemoradiation for LABC • Novel imaging of LABC to determine response to treatment • Outcomes • Establishment of population-based provincial cohort of DCIS, LCIS (Pathology) • Population-based assessment of cardiac toxicity following XRT for breast cancer

43. Medical Oncology : Accomplishments • Strong contribution to new international standards for adjuvant endocrine, biologic and chemotherapy via NCIC CTG (MA.5, MA.17, MA.17R, MA.21, MA.27) • Strong phase II program: • NCIC CTG • PMH Consortium • Strong Correlation phase I-IV programs • MA.22 • MA.29 • Chemo radiation • LABC programs • BLISS programs

44. Specialty Clinical Components • Primary Nursing Model • LABC • Brachytherapy • Lymphedema clinic • Breast prosthesis • BLISS

45. LABC Program Mission • To provide consistent, high quality, multidisciplinary care in a patient-centered or needs-led format. Objectives • Increase understanding of long-term clinical outcomes. • Design program of excellence. • Continue national preceptorship program for health care professionals.

46. Ongoing Clinical Trials Imaging: MRI Study (Wright) MRI Technique (Czarnota) Spectroscopy (Czarnota) Neoadjuvant Therapy: MA.22 (Trudeau) ATSEA (Clemons/Holloway/Verma) Chemorads (Spayne/Holloway) Psychosocial: Risk Perception Delayed Presentation Male Partner’s Role (Fergus/Fitzgerald)

47. LABC: The Future • Maintain high quality, multidisciplinary care for our patients • Re-institute RN lead program • Improve public awareness • Maintain LABC database • Improve outcomes for women with LABC

48. Breast Brachytherapy • 20 ~ 30% of patients with Early Stage Breast Cancer are potentially eligible • Unique to TSRCC in the GTA • Includes 2 types of procedures: • Permanent Breast Seed Implant • High Dose Rate (HDR) brachytherapy

49. PermanentBreast Seed Implant • Developed at Sunnybrook • Not (yet) offered anywhere else • Huge PR impact • Visitors from USA and Europe • Main advantages : • 1 hour procedure • Minimal toxicity • Minimal exposure of radiation to normal tissues • Current Status • Phase I/II Trial complete (65 patients) • Presented at international meetings

50. HDR Brachytherapy • Different technique • Insertion of multiple catheters • Treatment is delivered bid x 5 days • Advantages: • can be used in cases where seeds not feasible • Large seroma • Large volumes • Great potential for Image Guided Brachytherapy research • Status • NSABP B-39