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What is the Preferable Treatment Option for T1/T2 Low Rectal Cancer?

What is the Preferable Treatment Option for T1/T2 Low Rectal Cancer?. Christopher H. Crane , M.D. Program Director, GI Section Department of Radiation Oncology. No Disclosures. Complications of Radical Rectal Surgery. Permanently altered bowel function Often colostomy

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What is the Preferable Treatment Option for T1/T2 Low Rectal Cancer?

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  1. What is the Preferable Treatment Option for T1/T2 Low Rectal Cancer? Christopher H. Crane, M.D. Program Director, GI Section Department of Radiation Oncology

  2. No Disclosures

  3. Complications of Radical Rectal Surgery • Permanently altered bowel function • Often colostomy • Urinary dysfunction from 7-68% • Impotence 15-100% • Retrograde ejaculation 3-35%

  4. Chemoradiation Followed by Local Excision* *Responding patients

  5. NCDB LE Special Study (1994-96)Local Recurrence – T2 N=164 T2: p=0.01 N=866 You et al. Ann Surg 245(5):726-33, 2007

  6. German Trial (CAO / ARO / AIO)Pre-operative vs Postoperative CXRT • Significantly lower acute toxicity rate • 27% vs 40%, p=0.001 • LR improved with preoperative CXRT • 5 yr: 6% vs 13%, p=0.001 • SP higher in preoperative CXRT • 39% vs 19%, p=0.006 • Subjective need for APR, not whole group • Significantly lower late toxicity • 14% vs 24%, p=0.01 • anastamotic stricture (12% vs 4%) • Diarrhea, SBO (9% vs 15%) Sauer, R NEJM, 351, 2004

  7. Can Radical Surgery Be Avoided in Selected Rectal Cancer Patients?

  8. CXRT / Mesorectal resection- cT3 N0 ptsypN+ according to ypT stage Crane, pESTRO 2004 ypT0 in T3 NX (including clinically node +) = 4/45 = 9% Bedrosian, J Gastroint Surg, 2004

  9. Local Excision of T3 tumors after Preoperative XRT

  10. Local Excision of T2 tumors after Preoperative XRT

  11. Cumulative recurrence rates based on ypT StageCXRT/LE (cT2/cT3) Modified from Table 5, Borschitz, et al Ann Surg Onc, 2008

  12. Randomized Trial - T2 Rectal Cancer CXRT then TAE vs Laparoscopic Resection • 40 pts • 50.4 Gy + PVI 5-FU (200 mg/m2) • 20 TAE • 20 LAP Resection • One recurrence in each group (5%) • Median FU 56 mo Lezoche, et al Surgical Oncology, 2005

  13. Complications, CXRT / TAE • Wound complications do not appear to be a limitation • Diverting iliostomy could be perfomed Modified from Table 3, Borschitz, et al Ann Surg Onc, 2008

  14. Non-operative Management in Complete Responders? • University of São Paulo, Brazil • Pre-op Chemoradiation (50.4 Gy + FU/LV) • 265 pts • Clinical CR = observation (n=71, 26%) • 2 endorectal failures, 5y OS 100% • Incomplete CR / radical surgery, pCR (n=22%, 8.3%) • 2 DOD, 5y OS 88% • Median follow-up 57.3 months Habr-Gama, Ann Surg. 240(4):711-718, 2004

  15. ACOSOG Z6041 Study Design Primary Obj: 3 yr DFS in uT2N0 T0-T2 R0: Observation Follow uT2 rectal cancer (EUS-MRI) CXRT Cape (850mg/m2 bid) oxali (50 mg/m2/wk) 54 Gy Local excision T3 or R+: radical resection <8 cm from anal verge <4 cm size Chan, ASTRO 2010

  16. ACOSOG Z6041 Study Design Primary Obj: 3 yr DFS in uT2N0 T0-T2 R0: Observation Follow uT2 rectal cancer (EUS-MRI) CXRT Cape (650mg/m2 bid) oxali (50 mg/m2/wk) 50.4Gy Local excision T3 or R+: radical resection <8 cm from anal verge <4 cm size Chan, ASTRO 2010

  17. ConclusionsNeoadjuvant CRT with CAPOX • 44% pCR • Only 5% of patients needed radical surgery • Long term follow-up is needed for LC endpoint • High GI toxicity rates Chan, ASTRO 2010

  18. Organ Preservation ModelLocally Advanced Rectal Ca • Clinical selection will affect success • Tumor size, nodal status, tumor grade, others • Neoadjuvant CXRT • Endoscopic CR • Full thickness local excision = excisional biopsy of tumor bed • ypT0, no further surgery • Radical surgery only for non-responders: • Gross residual disease or ypT3 • What about microscopic residual disease? Crane, Annals of Surg Onc, (3) p288-90, 2006

  19. Response of Primary Tumor to CXRT • Observing response of primary key to organ preserving strategy • Predicts Control of Microscopic Mesorectal Disease • Could predicting response help? • Only if it leads to personalized therapy • Increase the pool of responders • Pair agents to patients • Proteomics, genomics • Change agents during therapy (PET)?

  20. The Message RegardingPre-op/LE • Promising strategy, especially in responding patients • Better long term GI and sexual function • Salvage rates of LR 50-70% • Close FU is critical • Multidisciplinary team has to be on the same page

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