Cornelis J.H. van de Velde, MD, PhD,FRCPS(hon)FACS(hon) Professor of Surgery

1. How important is experience/volume in gastric cancer surgery? Cornelis J.H. van de Velde, MD, PhD,FRCPS(hon)FACS(hon) Professor of Surgery President ECCO - the European Cancer Organization Past-President European Society of Surgical Oncology Leiden University Medical Center Leiden, The Netherlands

2. Pean and Billroth Surgery for gastric cancer

3. Importance of training and team effort Surgical oncology is top-class sport Training and (multidisciplinary) team effort essential

5. Japanese vs Intergroup 0116 study Japanese study Intergroup 0116 study red line: 60% survival, surgery only in Japanese trial MacDonald, NEJM 2001, Sakuramoto, NEJM 2007

6. Dutch Gastric Cancer Trial Hospital volumes • 711 gastrectomies, 80 participating hospitals • Average of 2.2 gastrectomies/hospital/year (registered in study) Quality Assurance • Instruction in operating room by Japanese surgeon • ‘Supervising surgeons’ present with every D2 gastrectomy • Book and video • Teaching meetings for surgeons

7. Dutch Gastric Cancer Trial – 15-year follow-up 711 Patients with curative resection Conclusion D2 dissection should be recommended as standard surgical approach in resectable gastric cancer Death of Gastric Cancer D1: 48% D2: 37% P=0.01 Death of Other Causes HR=1.22 P=NS Songun, vd Velde et al, Lancet Oncology 2010

8. Conclusion on surgery D2 dissection should be recommended No splenectomy or pancreatectomy In experienced(High volume) centers PAND does not improve survival any further

9. After Dutch D1-D2 trial During Dutch D1-D2 trial Before Dutch D1-D2 trial Perioperative chemotherapy Surgery Alone The effect of improvement of surgical quality over the introduction of adjuvant therapy Krijnen et al., EJSO 2009

10. Trials vs nationwide improvements • Trials → improve outcomes by • Providing better treatment options • Training surgeons • Most patients treated outside trials • → analyze outcomes on nationwide level

11. 2 Ways to improve surgical outcomes Direct patients to the best places (“Centers of Excellence”) Improve care by everyone (“Quality improvement”) Off-the-shelf process improvement Outcomes-based quality improvement

12. Survival in the Netherlands compared to Europe EUROCARE-4 5-Year relative survival Europe: 24.5% Netherlands: 18.1% Are we doing something wrong? Sant et al, Eur J Cancer 2009

13. Centralization in the Netherlands Esophagectomy Gastrectomy RED = High-volume surgery (>20/year) • Esophagectomy: centralization effect • Gastrectomy: decreasing number, no centralization Dikken, vd Velde et al, EJC 2012

14. Outcomes esophagectomy vs gastrectomy • 6-Month mortality: • Gastrectomy → non-significant decrease • Esophagectomy → significant decrease • 3-Year survival: • Gastrectomy → no improvement • Esophagectomy → catch-up with gastric cancer Dikken, vd Velde et al, EJC 2012

15. 30-Day mortality in the Netherlands Blue: esophagectomy ~ 4% Green: gastrectomy ~ 8% Higher mortality after gastrectomy for past 5 years Dikken, vd Velde et al, EJC 2012

16. Conclusion • Urgent need for improvement of gastric cancer care in the Netherlands • Centralization • Auditing • Use of multi-modality treatment

17. Centralization: volume-outcome relation US “Patients can often improve their chances of survival substantially, even at high volume hospitals, by selecting surgeons who perform the operations frequently” Birkmeyer et al, NEJM 2002

18. Centralization: volume-outcome relation US • 10 years after initial US paper • Decrease in postoperative mortality • Esophagectomy: completely due to centralization Finks et al, NEJM 2012

19. Centralization in Denmark • 2003 • Gastric cancer surgery restricted to 5 hospitals • Introduction national clinical guidelines • Introduction nationwide database Jensen et al, ejso2010

20. Centralization in Denmark Cases with at least 15 lymph nodes removed 2003: 19% 2008: 67% Jensen et al, EJSO 2010

21. Literature on GastrectomiesNumber of patients in volume-outcome studies • Smaller studies: often no volume-outcome effect • Larger studies: volume-outcome effect

22. Literature on Gastrectomies Definition of ‘high volume’ in positive studies • Definition of ‘high volume’ in most studies ~20/year • But studies with higher volumes

23. Centralization: type of referral Should centralization only be based on case volume? Volume-based vs. Outcome-based referral Gruen et al, CA Cancer J Clin 2009

24. Outcome-based centralization in West-Netherlands • Surgical audit for Esophagectomies • 11 low volume hospitals • 10 years of retrospective data (1990-1999) • INTERVENTION in 2000 • Concentration of procedures in 3 hospitals • with the best performance Wouters et al, J Surg Oncol 2009

25. Improvement after outcome-based centralization J Surg Oncol 2009

26. Effects on survival Significant improvement in survival after esophagectomy J Surg Oncol 2009

27. Comparison with rest of the Netherlands hospital mortality W W W J Surg Oncol 2009

28. Conclusion Outcome-based referral provides a method for centralization by selecting hospitals with the best outcomes

29. Auditing • Definition • “providers of care are monitored and their performance is benchmarked against their peers” • Surgical Hawthorne effect • Gastric cancer audits currently performed in several European Countries • United Kingdom • Denmark • Sweden • Netherlands

30. Effect of auditing Feedback Knowledge transfer

31. Great Britain National OesophagoGastric Cancer Audit • Patient characteristics • Preoperative staging • Treatment modalities • Surgery • Multi-modality • Outcomes • Complications/mortality • Survival • Quality of Life www.augis.org

32. Analyzing risk-adjusted outcomes on hospital level www.augis.org

33. Netherlands • Started as of 2011:minimal 40 procedures in 2012 • Covering all esophagectomies and gastrectomies in the Netherlands • Collaboration with Colorectal Audit, Breast Audit www.clinicalaudit.nl

34. International comparison Compare national audits and cancer registries Esophageal and gastric resections 2004-2009 Netherlands: N = 5,791 Sweden: N = 653 (part of Sweden) Denmark: N = 1,420 England: N = 12,000 Goals Compare differences between countries Analyse possible volume-outcome relation

35. Differences in 30-day mortality between countries Esophagectomies Gastrectomies Significant differences between countries

36. Differences in annual hospital volumes Large differences in annual hospital volumes Denmark: centralization of esophagectomies and gastrectomies Esophagectomies Gastrectomies

37. Effect of hospital volume on 30-day mortality Esophagectomies Gastrectomies • Lower 30-day mortality with increasing hospital volume • Esophagectomies: up to >40/jaar • Gastrectomies: up to >20/jaar

38. Conclusions Participating countries: Considerable variation in hospital volumes and 30-day mortality Significant relation between volume and 30-day mortality But not the only explanation for differences between countries Limitations of this pilot study: Differences between used datasets Comorbidity, TNM stage, multimodality therapy Need for a uniform European Upper GI Cancer Registry

39. European Upper GI Registry(ESSO initiative ,chair : W Allum)

40. Quality Assurance Project: an ESSO initiative Quality Variation • Identify and spread Best Practice • Research • Outcome monitoring (feedback) • Guidelines Development One European Cancer Audit

41. Feedback by auditing • Casemix adjusted • Tools to improve • Identify best practice • Only feedback to participating registration

42. European Audit on Cancer Treatment Outcome

43. Levels of evidence

44. Conclusion • Nationwide improvements require nationwide interventions • Centralization • Auditing ‘The best care, for every cancer patient’