1. Why do we need Breast Clinics? Prof.Dr.M-R. Christiaens Multidisciplinair Borstcentrum

2. Incidence of Breast Cancer Far most frequent cancer in female Still considerable mortality Belgium > 7000 new cancers each year Public health question Quality in diagnosis, treatment and quality of life does matter!!!!

3. The ‘Quality Concept’ “I recognise it when I see it” What constitutes ‘quality’? How can we measure ‘quality’? How can we improve ‘quality’?

4. Eusoma Guidelines The Requirements of a Specialist Breast Unit, 2002 Quality assurance in the diagnosis of breast disease Quality control in the locoregional treatment of breast cancer Guidelines on endocrine therapy of breast cancer The curative role of radiotherapy in the treatment of operable breast cancer Prophylactic surgery

5. Guidelines NHS – BAS0 Guidelines The Requirements of a specialist Breast Unit R.W. Blamey et. Eur J Cancer 2002, 36, 2288-2293 Resolution European Parliament, 2003 KB Oncology Centers, 2003 – Specialised care programs KCE : Breast Cancer Screening; report vol.IIA, 2005 Oncology college ………2007? EUREF – European Guidelines for Quality Assurrance in Breast Cancer Screening and Diagnosis, 4th ed.; The requirements of a specialist unit, first revision European Communities, 2006 EORTC BCG – EUSOMA – Europa Donna EBCC-5 Nice 2006, Consensus Document Guidelines on the standards for the training of specialised health professionals dealing with breast cancer - EUSOMA (to be published)

6. Eusoma Objectives for Breast Units To make available for all women in Europe a high quality specialist Breast Service To define standards for such a service To recommend that a means of accreditation and audit of Breast Units be established in order that units providing this service would be recognisable to patients and to purchasers as being of high quality

7. Eusoma Accreditation of Breast Units Basic Criteria A single integrated Unit Sufficient cases to allow effective working and continuing expertise Care by breast specialists in all the required disciplines Working in multidisciplinarity in all areas Providing all necessary services: genetics, prevention, diagnosis, treatment, advanced disease and palliation Patient support Data collection and Audit

8. Eusoma Accreditation of Breast Units Basic Criteria A single integrated Unit Single geografical entity? –Allow multidisciplinary working –The same MDT –The same protocols –MD case management meetings –Single dataset –Audited as one Unit

9. Eusoma Accreditation of Breast Units Basic Criteria Sufficient cases to allow effective working and continuing expertise Case load 150 newly diagnosed patients/year ‘Surgeon’: 30 operations / year

10. Type of Hospital Teaching vs Non-Teaching Hospitals –Survival: odds ratio 1.46; p= 0.0009 Bassnet; Eur J Cancer 1992 –BCS in 72 vs 65% –RT after BCS in 82 vs 73 % Ruhee Chaudhry, CMAJ 2001 Participation in Clinical Trials and survival

11. Case load >< 30 new BC procedures/y: Survival RR: 0.85 150 new cases/year 1/3 have < 25 new cases/year 60% ‘multidisciplinary breast clinics’: 2/week – 1/year Sainsbury; Lancet 1995 Harries; The breast 1997 Training and Experience –Completeness of excision of NPL: p=0.0001 experience: 20 operations during study period –BCT vs Mastectomy: p=0.0003 (Dixon; Brit J Surg 1996) –Learning curve (Sentinel node procedure!) Full Therapeutic options - Multidisciplinarity

12. Case load per surgeon and outcome … D.M. Ingram et al; The Breast 2005 Treatment 20+ / y<20 / yOR (95% CI) BCS 53.336.71.96 (1.64–2.33) ALN-procedure 88.787.81.08 (0.83–1.41) Adjuvant RT 50.030.62.06 (1.70–2.50) Adjuvant CT 29.220.91.47 (1.14–2.89) Adjuvant HT 57.360.20.88 (0.75–1.06)

13. Case load per surgeon and outcome … D.M. Ingram et al; The Breast 2005 Year Surgical caseload 4-year survival5-year survival 1989 <2082% (78–85)75% (71–80) 20+86% (81–90)81% (75–86) 1994 <2084% (80–88)79% (76–85) 20+89% (86–92)85% (81–88) 1999 <2078% (71–85)NA 20+90% (88–92)NA

14. Hospital case load - extrapolated Number of cases /yNumber of Hospitals% women <25308 25-755348 75-1502620 > 150824 Total117100 CM Files 2006

15. Univariate analysis of Survival according to Case Load Women 50 to 69 year - stage II CM Files 2006

16. Variations in relative survival Invasive breast cancer West Midlands Cancer Intelligence Unit BASO Breast Group

17. Radiotherapy after BCS, generally with axillary clearance (BCS  RT) in all women (pN0, PN+) EBCTCG Breast cancer mortality in trials of Polychemotherapy versus Not, entry age 50-69

18. Eusoma Accreditation of Breast Units Basic Criteria Care by breast specialists in all the required disciplines Multidisciplinarity in all areas

19. Radiotherapy according to type of hospital - Stratification for age and stage of disease CM Files 2006

20. Treatment pattern according to case load – stratification for age (50-69) and stage of disease CM Files 2006

21. Eusoma Accreditation of Breast Units Basic Criteria Providing all necessary services: genetics, prevention, diagnosis, treatment, advanced disease and palliation Written, updated and evidence based protocols ‘Oncologisch Handboek’ ‘Individual patient decisions’

22. Care program with protocol Participation in Screening Diagnosis: mammo, US, MRI; FNAC / CNB / VACNB / Stereotactic procedures Pathology Benign Breast Disease Malignant Disease – all stages Supportive groups – Oncorevalidation – e.g. Reconstructive surgery Organised follow-up Familial and Hereditary Breast Cancer Counseling Palliative care Teaching Research: clinical – translational – basic (blood-tumor bank)

23. Eusoma Accreditation of Breast Units Basic Criteria Patient support for all patients - all stages Information Advocate Coach Buddy Guide Reduce anxiety ♀ 56 y; left mastectomy and ALND

24. Eusoma Accreditation of Breast Units Basic Criteria Data collection and Audit Q.T. Data collection on treatment of screen detected lesions, Ponti A, et al. European guidelines for quality assurance in breast screening and diagnosis, 3rd ed., European Communities 2001 MOC – Cancer registration Communication of results

25. QC in locoregional treatment- Eusoma Guidelines Targets Pre-treatment tripel assessment Palpable BC > 95% FNAC/CNB in BC > 90% NPBC, +FNAC/CNB> 80%

26. QA in diagnosis – Eusoma guidelines Targets Surgical aspects Wire 90% One operation NPL> 95% Benign lesions, 90% B:M ratio0.5 : 1 No FS, 95%

27. QC in locoregional treatment –Eusoma guidelines Targets Locally Advanced Breast cancer Definition: > 5 cm; skin involvement; chest wall (muscle or skeletal) involvement; fixed axillary lymphnodes; pN+ apex; T4d Aim: –Down staging –OS???? Outcome measure: > 80% multimodality treatment: RT, chemo, hormonal and surgical

28. Patient Partner children Radiologist Pathologist Breast Surgeon Gynaecologist Medical Oncologist Radiation Oncologist Nurses Ward Nurses Operation theatre Nurses Out patient clinic Plastic surgeon Nucleair Med Genetic Counseling Palliative team Anaesthesia Fysiotherapy Psychologist Nurses Day care unit GP BCN Support Groups Prosthesis Cosmetic advice Wigs Trial Nurse Receptionist Logistics Trainees BTB

29. Eusoma Accreditation of Breast Units R.W.Blamey and L. Cataliotti Eur J Cancer, July 2006 Need faced by patients and referring doctors Genuine claims to designate oneselves specialist units Need for a process of accreditation Voluntary ( EUREF Accreditation also voluntary!)

30. Survey of European Breast Cancer Services Directory of specialist breast cancer services initiated in collaboration with EUSOMA, aiming at providing patients and physicians with information on centres of expertise http://www.cancerworld.org/ebcs/en/bs/Directory.asp Belgium: 6Luxemburg: 1 France: 2United Kingdom:1 Germany: 3Netherlands: 1 Hungary: 1Spain: 2 Italy: 5Switzerland: 1 Portugal: 1Slovenia: 1 October 2006

31. Facilitate physicians’ acceptance of guidelines by not imposing liability for the failure to follow guidelines without determining the standard of care

32. The Belgian way?