作者
Jérémie H Lefevre, Laurent Mineur, Salma Kotti, Eric Rullier, Philippe Rouanet, Cécile de Chaisemartin, Bernard Meunier, Jafari Mehrdad, Eddy Cotte, Jérome Desrame, Mehdi Karoui, Stéphane Benoist, Sylvain Kirzin, Anne Berger, Yves Panis, Guillaume Piessen, Alain Saudemont, Michel Prudhomme, Frédérique Peschaud, Anne Dubois, Jérome Loriau, Jean-Jacques Tuech, Guillaume Meurette, Renato Lupinacci, Nicolas Goasgen, Yann Parc, Tabassome Simon, Emmanuel Tiret
发表日期
2016/11/1
期刊
Journal of Clinical Oncology
卷号
34
期号
31
页码范围
3773-3780
出版商
American Society of Clinical Oncology
简介
Purpose
A pathologic complete response (pCR; ypT0N0) of a rectal tumor after neoadjuvant radiochemotherapy (RCT) is associated with an excellent prognosis. Several retrospective studies have investigated the effect of increasing the delay after RCT. The aim of this study was to evaluate the effect of increasing the interval between the end of RCT and surgery on the pCR rate.
Methods
GRECCAR6 was a phase III, multicenter, randomized, open-label, parallel-group controlled trial. Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT (45 to 50 Gy with fluorouracil or capecitabine) were included. Patients were randomly included in the 7-week or the 11-week (11w) group. Primary end point was the pCR rate defined as a ypT0N0 specimen (NCT01648894).
Results
A total of 265 patients from 24 centers were enrolled between October 2012 and February 2015. The majority of the …
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JH Lefevre, L Mineur, S Kotti, E Rullier, P Rouanet… - Journal of Clinical Oncology, 2016