Neoadjuvant Therapy for Rectal Cancer is Overrated. Joon H. Lee, Research Resident University of Colorado 8/31/2009
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1 Neoadjuvant Therapy for Rectal Cancer is Overrated Joon H. Lee, Research Resident University of Colorado 8/31/2009
2 Objectives Brief overview of staging rectal cancer Current guidelines for evaluation and treatment of rectal cancer Data without benefit for five-year survival (5YSR) Benefit of neoadjuvant therapy Conclusions
3 Staging: American Joint Committee on Cancer (AJCC) Meredith et al. Surg Clin of N Amer. 2009
4 Stage-based Survival Meredith et al. Surg Clin of N Amer. 2009
5 Diagnostic Evaluation Establishing locoregional involvement with transrectal ultrasound Possible role of MRI to evaluate mesorectal node involvement Evaluation of distant metastases by CT scan Still controversial role of combined PET/CT for evaluation of distant metastases Meredith et al. Surg Clin of N Amer. 2009
6 Treatment Standard of Care Neoadjuvant Chemotherapy: 5-fluorouracil (5-FU), leucovorin, & oxaliplatin (FOLFOX) Neoadjuvant Radiotherapy: External beam radiation (XBR) no consensus on dose but 28 fractions, total 50.4 Gy used often Surgical resection: Low anterior resection (LAR), abdominal perineal resection (APR), local excision Fry et al. Sabiston Textbook of Surgery. 2007
7 German Rectal Cancer Study Group Randomized controlled trial (RCT) of preop vs. postop chemoradiotherapy Multicenter (26) trial with n=823, 421 in preop arm; 1 Endpoint of overall survival 50.4 Gy XBR and 5-FU Median follow-up 46 months Overall 5 YSR of 76% vs 74% (p=0.80) Sauer et al. NEJM. 2004
8 Cochrane Database Review 2007 Review of preoperative radiotherapy for localized resectable adenocarcinoma of rectum 20 randomized controlled studies Included studies with other included therapies if uniformly applied to both arms 19 studies failed to show significant overall survival benefit Wong et al. Cochrane Database Sys Rev. 2007
9 Wong et al. Cochrane Database Sys Rev. 2007
10 Wong et al. Cochrane Database Sys Rev Colorectal Cancer Collaborative Group. Lancet. 2001
11
12 5 Year Survival Benefit Prospective randomized multicenter trial with preoperative XBR (25 Gy over one week) versus surgery alone N=1168, 583 radiotherapy vs 585 control Local recurrence 11% vs 27% in control Overall 5 YSR 58% in experimental arm vs 48% in control Swedish Rectal Cancer Trial. NEJM. 1997
13 Swedish Rectal Cancer Trial Swedish Rectal Cancer Trial. NEJM. 1997
14 Discrepancies Exist There is no evidence of control of postoperative adjuvant therapies A local recurrence rate of 27% in the control arm is exorbitantly high Surgeons in neither arms performed total mesenteric excision (TME) Why is this study different from all other studies? Swedish Rectal Cancer Trial. NEJM. 1997
15 Total Mesenteric Excision In conjunction with either low anterior resection or abdominal perineal resection No blunt dissection of the mesorectum during rectal resection Careful sharp dissection, direct visualization, and care in preservation of autonomic nerves Avoid violation of tumor package, (i.e. mesorectal envelope) Reported local recurrence rate of 6 % without neoadjuvant therapy with n=301 Heald. Eur J Cancer. 1995
16 Dutch Colorectal Cancer Group Randomized multi-center controlled trial, n=1805; 897 preoperative XBR and TME, 908 TME alone Statistically significant increase in blood loss (p<0.001) and perineal complications (26% vs 18% p=0.05) in XBR group Kapiteijn et al. NEJM
17 Kapiteijn et al. NEJM
18 E Kapiteijn et al. Overall 2 year survival rate was 82% in experimental arm and 81.8% in control; Hazard ratio 1.02 No significant differences in distant and overall recurrence Significant decrease in local recurrence: 2.4% in neoadjuvant arm versus 8.2% (p<0.001) Kapiteijn et al. NEJM
19 Local Recurrence & Survival Med Res Coun RC WP. Br J Surg GA Higgins. Cancer A Gerard. Ann Surg M Buyse. JAMA JA Reis Neto. Dis Colon Rectum O Dahl. Cancer PA Goldberg. Eur J Cancer PJ Marsh. Dis Colon Rectum B Cedermark. Cancer Med Res Coun RC WP. Lancet Stockholm CCSG. Ann Surg Onc S Petersen. Chirug NP Nguyen. Am J Clin Onc MW Onaitis. Ann Surg Onc MW Onaitis. Ann Surg K Tankel. Am J Surg PJ Allen. J Gastrointest Sug JP Gerard. J Clin Onc KC Peeters. Ann Surg S Tsujinaka. Int J Colorectal Dis GJ Chang. Cancer HY Cheung. Surg Endosc D Sebag-Montefiore. Lancet. 2009
20 Management of Local Recurrence Locally recurrent rectal cancer has 5 YSR of 22-31% and local control of 50-71% Degrades quality of life; 1 symptom: Pain Surgery remains mainstay of treatment: APR, total pelvic exenteration, abdominosacral resection Multimodality therapy: Surgery, XBR, chemotherapy (again, FOLFOX), intraoperative radiotherapy Moriya. Japan J Clin Onc. 2006
21 Management of Local Recurrence Is there a survival benefit with combined modalities? A debate for another day. Moriya. Japan J Clin Onc. 2006
22 Conclusions No evidence of benefit of neoadjuvant therapies in 5 year survival rate Local recurrences are troubling but do not appear to impact overall survival Neoadjuvant chemoradiotherapy is overrated
23 Conclusions (continued) Buy a Swedish car, not a Swedish operation
24 Tack själv (Thank You in Swedish)
25 References 1. KL Meredith, SE Hoffe and D Shibata. The multidisciplinary management of rectal cancer. Surgical Clinics of North America. 2009; 89: RD Fry, N Mahmoud, DJ Maron, HM Ross and J Rombeau. Chapter 50 Colon and Rectum. Townsend: Sabiston Textbook of Surgery, 18th ed R Sauer, H Becker, W Hohenberger, C Rodel, C Wittekind, R Fietkau, P Martus, J Tschmelitsch, E Hager, CF Hess, JH Karstens, T Liersch, H Schmidberger, R Raab; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. The New England Journal of Medicine. 2004; 351: RK Wong, V Tandan, S De Silva and A Figueredo. Pre-operative radiotherapy and curative surgery for the management of localized rectal carcinoma. Cochrane Database of Systematic Reviews. 2007: CD Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8507 patients from 22 randomised trials. Lancet. 2001; 358: Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8507 patients from 22 randomised trials. Lancet. 2001; 358: Swedish Rectal Cancer Trial. Improved survival with preoperative radiotherapy in resectable rectal cancer. The New England Journal of Medicine. 1997; 336: Heald RJ. Rectal cancer: The surgical options. The European Journal of Cancer. 1995; 31A: E Kapteijn, CA Marijnen, ID Nagtegaal, H Putter, WH Steup, T Wiggers, HJ Rutten, L Pahlman, B Glimelius, JH van Krieken, JW Leer, CJ van de Velde. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. The New England Journal of Medicine. 2001; 345: Y Moriya. Treatment strategy for locally recurrent rectal cancer. Japanese Journal of Clinical Oncology. 2006; 36:
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