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+ + +. Treatment of Early Stage Rectal CA Sam Atallah, MD, FACS, FASCRS Colon and Rectal Surgery Center for Colon & Rectal Surgery November, 2011. Where are we now with the treatment of rectal cancer?. Stage I Rectal Cancer. TNM Classification Stage I Rectal Cancer T1 N0

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  2. Treatment of Early Stage Rectal CASam Atallah, MD, FACS, FASCRSColon and Rectal SurgeryCenter for Colon & Rectal SurgeryNovember, 2011

  3. Where are we now with the treatment of rectal cancer?

  4. Stage I Rectal Cancer TNM Classification Stage I Rectal Cancer • T1 N0 • Invasion into submucosa • T2 N0 • Invasion into muscularis propria

  5. Local Therapy or Radical Resection?

  6. Goals of Therapy Traditional Endpoints • Perioperative M&M • Recurrence • Locoregional • Distant • Survival • Disease Free • Overall

  7. Goals of Therapy The New Endpoints • Psychological – living with a bag • Urinary and sexual function • Minimizing scars on abdomen • ‘Organ’ preservation – continence vs stoma

  8. The Increasing Rate of Local Excision • 2124 patients with stage I rectal cancer • 765 LE • T1 601 T2 164 • 1359 SR • T1 493 T2 866 Source: Y. Nancy You, et al., Ann Surgery Vol 245 No. 5, 2007 726-33.

  9. 1989 vs 2003 • Increase rate of T1 local excision • 1989: 26.6% 2003: 43.7% • Increase rate of T2 local excision • 1989: 5.8% 2003: 16.8% p < 0.001 both Source: Y. Nancy You, et al., Ann Surgery Vol 245 No. 5, 2007 726-33.

  10. Source: Y. Nancy You, et al., Ann Surgery Vol 245 No. 5, 2007 726-33.

  11. What’s the basis for increase in LE? No level I or level II evidence to support oncologic adequacy of LE for stage I rectal cancer

  12. Oncologic Adequacy • Breast Cancer – Early Stage • MRM • Lumpectomy with adjuvant XRT • Equal oncologic outcomes • Level I Evidence: NSABP - 06 • Rectal Cancer – Early Stage • Standard Resection (APR/LAR) • Local Excision • Are these oncologically equivllent? • Level I or II Evidence: - - - - - -

  13. Local Excision • Transanal Approach • 1-2 cm margin • Full thickness • Oriented for pathology

  14. The Minimally Invasive Movement • Laparoscopic Colectomy: We invested great effort to show the SAME OPERATION can be done with a DIFFERENT techniques to provide same/better results. • COLOR: Colon Cancer Laparoscopic or Open Resection • COST: Clinical Outcomes of Surgical Therapy • CLASSIC: Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer • Transanal Excision: No level I/II data that a DIFFERENT OPERATION could be done with standard techniques to provide same/better results.

  15. So how did LE as therapy gain acceptance?

  16. Earlier Studies • “Local excision of carcinoma of the rectum for cure” • Retrospective Review • 53 patients • 44 months follow-up • Results: • 90% disease free survival • 8% local recurrence rate Source: Bailey HR, Max E, et al. Surgery 1992 May; 111(5):555-61.

  17. Morbidity of Standard Resection

  18. Source: You et al. Ann Surgery Vol 245 No. 5 May 2007

  19. Long-Term Results

  20. Trends in Local Excision • National Cancer Database • 1114 pts with pT1: Surgery ONLY • 616 (55%) underwent local excision • Factors: distal <5cm ~1cm dia. p<.001 • 498 (45%) underwent standard resection Source: N You, N Baxter, S Nelson H Nelson, J Clin Onc 2005 Vol 23 No 16

  21. T1 Rectal Cancer Local / regional tumor recurrence • 5 year follow up: • LE 12.7% • SR 6.1% p < 0.03 • 8 year follow up: • LE 14.4% • SR 9.5% p <0.01 Source: N You, N Baxter, S Nelson H Nelson, J Clin Onc 2005 Vol 23 No 16

  22. 5-YR OVERAL SURVIVAL 5-YR DIS SPECIFIC SURVIVAL Source: You et al. Ann Surgery Vol 245 No. 5 May 2007

  23. T2/LE 22% T2/SR 15% T1/LE 13% T1/SR 7% Source: You et al. Ann Surgery Vol 245 No. 5 May 2007

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  25. Local Excision of Rectal Cancer without Adjuvant therapy • Minneapolis, Minnesota • Retrospective Study • 82 Stage I lesions • T1 n = 55 • T2 n = 27 • Favorable Lesions Garcia-Aguilar, et al. Ann Surgery. 231(3):345-351, March 2000

  26. Tumor Characteristics • Tumor localized to rectal wall • Negative resection margins (R0) • Well/Moderately differentiated • No blood or lymphatic vessel invasion • Non-mucinous • Pre-op ERUS uT1 or uT2 and uN0 Garcia-Aguilar, et al. Ann Surgery. 231(3):345-351, March 2000

  27. Recurrence Rates at 54 months • 10/55 (18%) pT1 • 10/27 (37%) pT2 (Local Excision Without Adjuvant Therapy) Garcia-Aguilar, et al. Ann Surgery. 231(3):345-351, March 2000

  28. Local Excision Failure Rates T1 18% T2 37% (Local Excision Without Adjuvant Therapy) Garcia-Aguilar, et al. Ann Surgery. 231(3):345-351, March 2000

  29. T1 Lesions: A Closer Look

  30. T1 sub-staging • Sm1 Upper 1/3 • Sm2 Middle 1/3 • Sm3 Lower 1/3

  31. What’s the risk of Lymph Node Mets with T1 Lesions? • Mayo Clinic Data • 353 pts with T1 lesions underwent standard resection • Overall, LN involved 13% • Study subdivides T1 into sm1 sm2 sm3 Source: R. Nascimbeni, et al., Dis Colon Rectum, Vol 45, No.2; 200-206

  32. pT1 Rectal Cancer P value = 0.001 Source: R. Nascimbeni, et al., Dis Colon Rectum, Vol 45, No.2; 200-206

  33. Long-Term Survival After Local Excision • 144 patients T1 sessile adenoCA of lower or middle rectum • 70 pts underwent local excision only • 74 patients underwent oncologic resection • Median follow-up 8.1 years • pT1 stratified into sm1 sm2 sm3 Source:Nascimbeni, et al. DC & R; Vol. 47, No 11 2004 1773-9

  34. T1 sm3: LE vs SRLocal ExcisionFormal Resection Source: Nascimbeni, et al. DC & R; Vol. 47, No 11 2004 1773-9

  35. Survival Source: Nascimbeni, et al. DC & R; Vol. 47, No 11 2004 1773-9

  36. Anatomic Site Corman, Textbook Colon & Rectal Surgery 2002

  37. Risk of LN Mets by Site P value = 0.007 Source: R. Nascimbeni, et al., Dis Colon Rectum, Vol 45, No.2; 200-206

  38. What about patients with CPR? • Annals of Surgery: December 2010 • Korean Radiation Oncology Group • Yeo, Seung-Gu MD, et al. (1993 - 2007) • 333 Patients with locally advanced rectal cancer • All underwent STANDARD oncologic resection (APR or LAR) • All had ypT0 on final path • lymph nodes were evaluated and shown to be • ypN0 (304) 91.3% • ypN1 (22) 6.6% • ypN2 (7) 2% • TOTAL NODE (+) FOR ypT0 8.6% • 5 year Disease Free Survival • ypT0ypN0 88.5% • ypT0 ypN1 or ypN2 45.2% (p < 0.001)

  39. Long-Term Survival After Local Excision for T1 Rectal Carcinoma Without Chemoradiotherapy CFS = cancer-free survival; CSS = cancer-specific survival; NA = not available; OS = overall survival

  40. How about locally excised lesions treated with adjuvant therapy?

  41. T2 Lesions: LE + Adjuvant Therapy • Cancer and Leukemia Group B Study • 177 patients with T1 or T2 Rectal CA • Favorable lesions • < 4cm in diameter • <40% bowel cercumference • < 10 cm from dentate line Source: Steele, et al., Ann Surg Oncol 1999. 6(5):433-441

  42. T2 Lesions: LE + Adujvant Therapy • 51/177 lesions were pT2 • Received Post-Op adjuvant ChemoXRT • 5400 cGr/30 fractions • 5-Fluorocuracil 500mg/m2 Source: Steele, et al., Ann Surg Oncol 1999. 6(5):433-441

  43. T2 Lesions: LE + Adujvant Therapy • 48 month followup • Treatment Failure 10/51 • 5/10 pts local recurrence • 2/10 pts local and distant • 3/10 distant only • 19.6% Source: Steele, et al., Ann Surg Oncol 1999. 6(5):433-441

  44. ACOSOG - Z6041 • David M. Ota, MD & Heidi Nelson, MD • 85 patient enrollment • uT2 uN0 distal rectal CA • Up Front Capecitabine/Oxalipatin • Up Front Pelvic XRT 54 G • Then Local excision • End points: DFS at 3 years • 40 centers / Peter Cataldo

  45. What do we have to compare this to?

  46. TME • R. J. Heald, F.A.C.S. • Basingstoke, Hampshire • Lancet, 6-28-86 • 71/2-year consecutive series of 115 patients • 39 with margins > 1.5cm • TME technique for all • Recurrance at 5yrs: 3.7% • Traditional Recurrance: 30-40%Local recurrence after low anterior resection using the staple gun. Hurst PA, Prout WG, Kelly JM, Bannister JJ,WalkerRT • Br J Surg. 1982 May;69(5):275-6. • .

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