The TME trial after a median follow-up of 6 years - Increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma

被引:952
作者
Peeters, Koen C. M. J.
Marijnen, Corrie A. M.
Nagtegaal, Iris D.
Kranenbarg, Elma Klein
Putter, Hein
Wiggers, Theo
Rutten, Harm
Pahlman, Lars
Glimelius, Bengt
Leer, Jan Willem
van de Velde, Cornelis J. H.
机构
[1] Leiden Univ, Med Ctr, Dept Surg, Leiden, Netherlands
[2] Leiden Univ, Med Ctr, Dept Clin Oncol, Leiden, Netherlands
[3] Netherlands Canc Inst, Dept Radiotherapy, Amsterdam, Netherlands
[4] Radboud Univ Nijmegen Med Ctr, Dept Pathol, Nijmegen, Netherlands
[5] Leiden Univ, Dept Med Stat, Med Ctr, NL-2300 RA Leiden, Netherlands
[6] Univ Groningen, Univ Med Ctr Groningen, Dept Surg Oncol, Groningen, Netherlands
[7] Catharina Hosp, Dept Surg, Eindhoven, Netherlands
[8] Uppsala Univ, Akad Sjukhuset, Dept Surg, Uppsala, Sweden
[9] Uppsala Univ, Akad Sjukhuset, Dept Oncol, Uppsala, Sweden
[10] Karolinska Inst, Stockholm, Sweden
[11] Joint Ctr Radiat Oncol, Nijmegen, Netherlands
关键词
D O I
10.1097/01.sla.0000257358.56863.ce
中图分类号
R61 [外科手术学];
学科分类号
摘要
Objective: To investigate the efficacy of preoperative short-term radiotherapy in patients with mobile rectal cancer undergoing total mesorectal excision (TME) surgery. Summary Background Data: Local recurrence is a major problem in rectal cancer treatment. Preoperative short-term radiotherapy has shown to improve local control and survival in combination with conventional surgery. The TME trial investigated the value of this regimen in combination with total mesorectal excision. Long-term results are reported after a median follow-up of 6 years. Methods: One thousand eight hundred and sixty-one patients with resectable rectal cancer were randomized between TME preceded by 5 x 5 Gy or TME alone. No chemotherapy was allowed. There was no age limit. Surgery, radiotherapy, and pathologic examination were standardized. Primary endpoint was local control. Results: Median follow-up of surviving patients was 6.1 year. Five-year local recurrence risk of patients undergoing a macroscopically complete local resection was 5.6% in case of preoperative radiotherapy compared with 10.9% in patients undergoing TME alone (P < 0.001). Overall survival at 5 years was 64.2% and 63.5%, respectively (P = 0.902). Subgroup analyses showed significant effect of radiotherapy in reducing local recurrence risk for patients with nodal involvement, for patients with lesions between 5 and 10 cm from the anal verge, and for patients with uninvolved circumferential resection margins. Conclusions: With increasing follow-up, there is a persisting overall effect of preoperative short-term radiotherapy on local control in patients with clinically resectable rectal cancer. However, there is no effect on overall survival. Since survival is mainly determined by distant metastases, efforts should be directed towards preventing systemic disease.
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页码:693 / 701
页数:9
相关论文
共 39 条
[1]   LOCAL RECURRENCE OF COLORECTAL-CANCER - THE PROBLEM, MECHANISMS, MANAGEMENT AND ADJUVANT THERAPY [J].
ABULAFI, AM ;
WILLIAMS, NS .
BRITISH JOURNAL OF SURGERY, 1994, 81 (01) :7-19
[2]  
Arnott SJ, 1996, LANCET, V348, P1610
[3]   Chemotherapy with preoperative radiotherapy in rectal cancer [J].
Bosset, Jean-Francois ;
Collette, Laurence ;
Calais, Gilles ;
Mineur, Laurent ;
Maingon, Philippe ;
Radosevic-Jelic, Ljiljana ;
Daban, Alain ;
Bardet, Etienne ;
Beny, Alexander ;
Ollier, Jean-Claude .
NEW ENGLAND JOURNAL OF MEDICINE, 2006, 355 (11) :1114-1123
[4]   Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: Preliminary results - EORTC 22921 [J].
Bosset, JF ;
Calais, G ;
Mineur, L ;
Maingon, P ;
Radosevic-Jelic, L ;
Daban, A ;
Bardet, E ;
Beny, A ;
Briffaux, A ;
Collette, L .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (24) :5620-5627
[5]  
BOULISWASSIF S, 1984, CANCER-AM CANCER SOC, V53, P1811, DOI 10.1002/1097-0142(19840501)53:9<1811::AID-CNCR2820530902>3.0.CO
[6]  
2-H
[7]   Effectiveness of preoperative staging in rectal cancer: digital rectal examination, endoluminal ultrasound or magnetic resonance imaging? [J].
Brown, G ;
Davies, S ;
Williams, GT ;
Bourne, MW ;
Newcombe, RG ;
Radcliffe, AG ;
Blethyn, J ;
Dallimore, NS ;
Rees, BI ;
Phillips, CJ ;
Maughan, TS .
BRITISH JOURNAL OF CANCER, 2004, 91 (01) :23-29
[8]   Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer [J].
Bujko, K. ;
Nowacki, M. P. ;
Nasierowska-Guttmejer, A. ;
Michalski, W. ;
Bebenek, M. ;
Kryj, M. .
BRITISH JOURNAL OF SURGERY, 2006, 93 (10) :1215-1223
[9]   Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy [J].
Bujko, K ;
Nowacki, MP ;
Nasierowska-Guttmejer, A ;
Michalski, W ;
Bebenek, AB ;
Pudelko, M ;
Kryj, A ;
Oledzki, J ;
Szmeja, J ;
Sluszniak, J ;
Serkies, K ;
Kladny, J ;
Pamucka, A ;
Kukolowicz, P .
RADIOTHERAPY AND ONCOLOGY, 2004, 72 (01) :15-24
[10]  
CEDERMARK B, 1995, CANCER-AM CANCER SOC, V75, P2269, DOI 10.1002/1097-0142(19950501)75:9<2269::AID-CNCR2820750913>3.0.CO