Douglas S. Scherr, M.D. Weill Medical College of Cornell University

1. Minimally Invasive Approaches in the Treatment of Urothelial Carcinoma“Robotic Radical Cystectomy” Douglas S. Scherr, M.D. Weill Medical College of Cornell University

2. Robotics Beyond The Prostate • Radical Cystectomy • Can we achieve equal oncological outcome?

3. Radical Cystectomy • Gold Standard for Invasive Disease • Role in T1 Disease • Quality of surgery impacts outcome and survival

4. Was the Effect all Chemotherapy?Are surgical variables important? • Post cystectomy survival predicted by: a.) age b.) stage c.) node status d.) negative surgical margins e.) >10 nodes removed • Hazard ratio for death: a.) 2.7 for + surgical margin b.) 2.0 for <10 nodes removed Herr et al. JCO, 22(14): 2781, 2004

5. Radical Cystectomy for T1 TCC • USC Experience: 208 pts with T1 disease • USC Experience with T2 disease Recurrence Free Survival Overall Survival 5 Year 10 Year 5 Year 10 Year 80% 75% 74% 51% Recurrence Free Survival Overall Survival 5 Year 10 Year 5 Year 10 Year 81% 80% 72% 56% Stein et al., J Clin Oncol, 19(3): 666-75, 2001

6. Early Vs. Late Cystectomy • 90 pts who had TUR + BCG ultimately underwent cystectomy • 41/90 had T1 disease • Median Follow up of 96 mos Early cystectomy (<2 years): 92% survival Late cystectomy (>2 years): 56% survival Herr and Sogani, J Urol, 166: 1296-9, 2001

7. Extent of Lymphadenectomy • Is there more to the node dissection than staging? • 1936 Colston and Leadbetter performed studies on 98 cadavers “limited metastatic disease was restricted to the pelvic nodes” • 1946 – Dr. Jewett “cardinal site of metastasis” Colston and Leadbetter, J Urol, 36: 669, 1936 Jewett et al. J Urol, 55: 366, 1946

8. Extent of Lymphadenectomy • Node positive patients can enjoy long term survival • 24% of grossly node positive disease survived 10 years without adjuvant therapy • More nodes removed correlates with improved survival Sanderson et al. Urol Oncol., 22: 205, 2004

9. Extent of Lymphadenectomy • Likely no staging advantage to extending the node dissection above the aortic bifurcation • 33% of unsuspected nodes found at common iliacs • Practice patterns vary widely: a.) 40% of cystectomies have no LND b.) 12.7% of LND had <4 nodes removed Lymph node density (# pos nodes/total # nodes) Konety et al. J Urol, 170: 1765, 2003

10. Extent of Pelvic Lymph Node Dissection IMA Genitofemoral nerve Genitofemoral nerve Aortic Nodes Common Iliac Nodes Hypogastric and Obturator Nodes

11. Survival By Number Of Lymph Nodes Removed Herr et al. JCO, 22(14): 2781, 2004

12. Postcystectomy survival by node status and number of nodes removed Herr, H. W. et al. J Clin Oncol; 22:2781-2789 2004

13. Post Cystectomy Survival Herr, H. W. et al. J Clin Oncol; 22:2781-2789 2004

14. Gold Standard • Open radical cystectomy (RC) is the gold standard for treatment of muscle-invasive bladder cancer.

15. Minimally Invasive Bladder Cancer Surgery • Efforts to reduce the operative morbidity of RC have fostered interest in minimally invasive approaches. • Laparoscopic RC • Robot-assisted laparoscopic RC

16. Concerns of Robotic Cystectomy? • Concerns regarding minimally invasive RC • Absence of long term oncologic outcomes • Absence of long term functional outcomes • Limited pelvic lymphadenectomy • Longer operative time • Increased cost Miller NL et al: World J Urol (2006) 24:180

17. Outcome Measures of Minimally Invasive Bladder Surgery • Previous reports comparing open versus minimally invasive RC have focused on perioperative outcomes. • Blood loss • Operative time • Analgesic requirement • Time to regular diet • Length of hospital stay Hemal AK et al: Urol Clin N Am (2004) 31:719 Basillote JB et al: J Urol (2004) 172:489 Taylor GD et al: J Urol (2004) 172:1291 Galich A et al: JSLS (2006) 10:145 Rhee JJ et al: BJU Int (2006) 98:1059

18. Comparison of Surgical Techniques • Lymph node yield • Margin status • However, direct comparison between open and minimally invasive RC of early oncologic parameters is lacking.

19. Study Comparison • Comparison of perioperative and early pathologic outcomes in a consecutive series of open and robotic RCs at our institution.

20. Methods • 100 consecutive patients underwent RC by a single surgeon at our institution 2006-2007 • 22 open • 78 robotic

21. Technique • Posterior dissection • Isolation of ureters • Lateral dissection • Control of bladder pedicles • Anterior dissection • Control of DVC and division of urethra • Control of prostate pedicles and nerve-sparing • Pelvic lymph node dissection • External iliac, hypogastric, and obturator lymphadenectomy up to the level of the mid-common iliac vessels • Extracorporeal urinary diversion through a 5-7cm midline incision • Orthotopic neobladder: robot re-docked for urethral neovesical anastomosis

23. Data Collection and Analysis • Data was collected prospectively • Patient characteristics • Perioperative outcomes • Early pathologic outcomes • Data analysis • Chi-square test • Fisher’s exact test • Student’s t-test

24. Results: Patient Characteristics • There was no difference in the following parameters among the 2 cohorts. • Age • BMI • ASA class • Prior abdominal surgery • Prior abdominal radiation • Neoadjuvant chemotherapy

25. Results: Clinical Stage

26. Urinary Diversion

27. Operative Time * P < 0.05

28. Robotic Learning Curve * P < 0.05

29. Blood Loss & Postoperative Parameters * P < 0.05

30. Postoperative Complications

31. Pathologic Stage * P < 0.05

32. Node & Margin Status * P < 0.05

33. Cost Results

34. Cost Conclusions • Robotic cystectomy appears more cost-effective than open cystectomy for treatment of bladder cancer • Majority of improvement driven by lower LOS • High initial materials cost of robotic surgery defrayed by subsequent cost savings during hospitalization • Annual robotic volume does not need to be high (<25 cases per year) to justify use of robotic cystectomy • Cost savings of robotic cystectomy however is diminished with decreased open cystectomy LOS (2 to 9 days)

35. Conclusions:Robotic Cystectomy • Increased operative time • significantly longer operative time in the robotic neobladder cohort (p=0.01) • Decreased operative time with increased experience • 450 to 338 min (p=0.007)

36. Conclusions:Robotic Cystectomy • Decreased • Blood loss • Transfusion requirement • Time to regular diet • Length of hospital stay

37. Conclusions:Robotic Cystectomy • Equivalent lymph node yield • 17.4 (robotic) vs. 18.9 (open), p=0.6 • Equivalent margin rate • 2% (robotic) vs. 8% (open), p=0.2 • Long term oncologic and functional outcomes are required Stein JP et al: J Urol (2003) 170: 35 Herr H et al: J Urol (2004) 171: 1823

38. Minimally Invasive Cystectomy • Minimally Invasive = Cancer Sparing

39. Future Directions • Prostate Sparing? • Improved Diagnostics

40. Prostate Sparing Cystectomy • Role for improved continence and potency • Need to rule out prostate cancer or TCC of prostatic urethra • Functional Results are good: a.) 97% complete continence b.) No episodes of retention c.) 82% maintained potency Vallancien et al. J Urol, 168: 2413, 2002

41. Prostate Sparing Cystectomy • Incidence of Pca is 30-50% with approx. 48% are clinically significant • 60% of CaP involve the apex (79% significant and 42% insignificant) • 48% of prostates had urothelial ca involvement of which 33% had apical involvement

42. Multiphoton Images

43. Multiphoton Images