Maxime K Collard, Laurent Mineur, Célia Nekrouf, Quentin Denost, Philippe Rouanet, Cécile de Chaisemartin, Aude Merdrignac, Mehrdad Jafari, Eddy Cotte, Jérôme Desrame, Gilles Manceau, Stéphane Benoist, Etienne Buscail, Mehdi Karoui, Yves Panis, Guillaume Piessen, Alain Saudemont, Michel Prudhomme, Frédérique Peschaud, Anne Dubois, Jérôme Loriau, Jean-Jacques Tuech, Emilie Duchalais, Renato Lupinacci, Nicolas Goasgen, Tabassome Simon, Yann Parc, Jérémie H Lefevre
{"title":"关于局部晚期直肠癌新辅助放化疗后等待期的 GRECCAR-6 试验的最终结果：5 年随访。","authors":"Maxime K Collard, Laurent Mineur, Célia Nekrouf, Quentin Denost, Philippe Rouanet, Cécile de Chaisemartin, Aude Merdrignac, Mehrdad Jafari, Eddy Cotte, Jérôme Desrame, Gilles Manceau, Stéphane Benoist, Etienne Buscail, Mehdi Karoui, Yves Panis, Guillaume Piessen, Alain Saudemont, Michel Prudhomme, Frédérique Peschaud, Anne Dubois, Jérôme Loriau, Jean-Jacques Tuech, Emilie Duchalais, Renato Lupinacci, Nicolas Goasgen, Tabassome Simon, Yann Parc, Jérémie H Lefevre","doi":"10.1097/DCR.0000000000003477","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The potential oncological benefit of extending the waiting period between neoadjuvant radiochemotherapy and surgical resection for rectal cancer is debated.</p><p><strong>Objective: </strong>To evaluate the impact of prolonging this waiting period on the 5-year oncological prognosis and 2-year functional result of locally advanced rectal adenocarcinoma.</p><p><strong>Design: </strong>Phase III, multicenter, randomized, open-label, parallel-group, controlled trial.</p><p><strong>Settings: </strong>Patients were enrolled from 24 colorectal centers.</p><p><strong>Patients: </strong>Patients with non-metastatic mid or lower cT3-4 or TxN+ rectal adenocarcinoma who had received radio-chemotherapy (45 to 50 Gy with fluorouracil or capecitabine).</p><p><strong>Intervention: </strong>Patients were randomly assigned to undergo total mesorectal excision either 7 weeks (W7) or 11 weeks (W11) after radiochemotherapy.</p><p><strong>Main outcomes measures: </strong>Overall survival and disease-free survival at 5 years of follow-up and low anterior resection syndrome score assessed after 2 years of follow-up.</p><p><strong>Results: </strong>Among 265 patients enrolled, 133 were randomized in the 7-week group and 132 in the 11-week group. Twelve patients were excluded as they did not undergo resection. Among 253 patients analyzed, 5-year overall survival was not different between the two groups (81.6% in 7-week group versus 82.6% in 11-week group, p = 0.827), as well as for the 5-year disease-free survival (70.4% in 7-week group versus 69.5% in 11-week group, p = 0.856). No difference was observed between the two groups for distant recurrence (27.4% in 7-week group versus 25.7% in 11-week group, p = 0.777) or local recurrence (8.4% in 7-weeks group versus 10.2% in 11-week group, p = 0.543). Low anterior resection syndrome score was similar between the 7-week (25.0 IQR [15.0-34.0]) and 11-week groups (23.0 IQR[14.2-32.0], p = 0.743).</p><p><strong>Limitations: </strong>The response rate to the LARS questionnaire was only 52%.</p><p><strong>Conclusions: </strong>Extending the waiting period between radiochemotherapy and resection from 7 to 11 weeks does not modify the 5-year oncological prognosis in rectal cancer and the 2-year low anterior resection occurrence.</p>","PeriodicalId":11299,"journal":{"name":"Diseases of the Colon & Rectum","volume":" ","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Final Results of the GRECCAR-6 Trial on Waiting Period Following Neoadjuvant Radiochemotherapy for Locally Advanced Rectal Cancer: 5 Years of Follow-up.\",\"authors\":\"Maxime K Collard, Laurent Mineur, Célia Nekrouf, Quentin Denost, Philippe Rouanet, Cécile de Chaisemartin, Aude Merdrignac, Mehrdad Jafari, Eddy Cotte, Jérôme Desrame, Gilles Manceau, Stéphane Benoist, Etienne Buscail, Mehdi Karoui, Yves Panis, Guillaume Piessen, Alain Saudemont, Michel Prudhomme, Frédérique Peschaud, Anne Dubois, Jérôme Loriau, Jean-Jacques Tuech, Emilie Duchalais, Renato Lupinacci, Nicolas Goasgen, Tabassome Simon, Yann Parc, Jérémie H Lefevre\",\"doi\":\"10.1097/DCR.0000000000003477\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The potential oncological benefit of extending the waiting period between neoadjuvant radiochemotherapy and surgical resection for rectal cancer is debated.</p><p><strong>Objective: </strong>To evaluate the impact of prolonging this waiting period on the 5-year oncological prognosis and 2-year functional result of locally advanced rectal adenocarcinoma.</p><p><strong>Design: </strong>Phase III, multicenter, randomized, open-label, parallel-group, controlled trial.</p><p><strong>Settings: </strong>Patients were enrolled from 24 colorectal centers.</p><p><strong>Patients: </strong>Patients with non-metastatic mid or lower cT3-4 or TxN+ rectal adenocarcinoma who had received radio-chemotherapy (45 to 50 Gy with fluorouracil or capecitabine).</p><p><strong>Intervention: </strong>Patients were randomly assigned to undergo total mesorectal excision either 7 weeks (W7) or 11 weeks (W11) after radiochemotherapy.</p><p><strong>Main outcomes measures: </strong>Overall survival and disease-free survival at 5 years of follow-up and low anterior resection syndrome score assessed after 2 years of follow-up.</p><p><strong>Results: </strong>Among 265 patients enrolled, 133 were randomized in the 7-week group and 132 in the 11-week group. Twelve patients were excluded as they did not undergo resection. Among 253 patients analyzed, 5-year overall survival was not different between the two groups (81.6% in 7-week group versus 82.6% in 11-week group, p = 0.827), as well as for the 5-year disease-free survival (70.4% in 7-week group versus 69.5% in 11-week group, p = 0.856). No difference was observed between the two groups for distant recurrence (27.4% in 7-week group versus 25.7% in 11-week group, p = 0.777) or local recurrence (8.4% in 7-weeks group versus 10.2% in 11-week group, p = 0.543). Low anterior resection syndrome score was similar between the 7-week (25.0 IQR [15.0-34.0]) and 11-week groups (23.0 IQR[14.2-32.0], p = 0.743).</p><p><strong>Limitations: </strong>The response rate to the LARS questionnaire was only 52%.</p><p><strong>Conclusions: </strong>Extending the waiting period between radiochemotherapy and resection from 7 to 11 weeks does not modify the 5-year oncological prognosis in rectal cancer and the 2-year low anterior resection occurrence.</p>\",\"PeriodicalId\":11299,\"journal\":{\"name\":\"Diseases of the Colon & Rectum\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diseases of the Colon & Rectum\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/DCR.0000000000003477\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diseases of the Colon & Rectum","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/DCR.0000000000003477","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Final Results of the GRECCAR-6 Trial on Waiting Period Following Neoadjuvant Radiochemotherapy for Locally Advanced Rectal Cancer: 5 Years of Follow-up.
Background: The potential oncological benefit of extending the waiting period between neoadjuvant radiochemotherapy and surgical resection for rectal cancer is debated.
Objective: To evaluate the impact of prolonging this waiting period on the 5-year oncological prognosis and 2-year functional result of locally advanced rectal adenocarcinoma.
Design: Phase III, multicenter, randomized, open-label, parallel-group, controlled trial.
Settings: Patients were enrolled from 24 colorectal centers.
Patients: Patients with non-metastatic mid or lower cT3-4 or TxN+ rectal adenocarcinoma who had received radio-chemotherapy (45 to 50 Gy with fluorouracil or capecitabine).
Intervention: Patients were randomly assigned to undergo total mesorectal excision either 7 weeks (W7) or 11 weeks (W11) after radiochemotherapy.
Main outcomes measures: Overall survival and disease-free survival at 5 years of follow-up and low anterior resection syndrome score assessed after 2 years of follow-up.
Results: Among 265 patients enrolled, 133 were randomized in the 7-week group and 132 in the 11-week group. Twelve patients were excluded as they did not undergo resection. Among 253 patients analyzed, 5-year overall survival was not different between the two groups (81.6% in 7-week group versus 82.6% in 11-week group, p = 0.827), as well as for the 5-year disease-free survival (70.4% in 7-week group versus 69.5% in 11-week group, p = 0.856). No difference was observed between the two groups for distant recurrence (27.4% in 7-week group versus 25.7% in 11-week group, p = 0.777) or local recurrence (8.4% in 7-weeks group versus 10.2% in 11-week group, p = 0.543). Low anterior resection syndrome score was similar between the 7-week (25.0 IQR [15.0-34.0]) and 11-week groups (23.0 IQR[14.2-32.0], p = 0.743).
Limitations: The response rate to the LARS questionnaire was only 52%.
Conclusions: Extending the waiting period between radiochemotherapy and resection from 7 to 11 weeks does not modify the 5-year oncological prognosis in rectal cancer and the 2-year low anterior resection occurrence.
期刊介绍：
Diseases of the Colon & Rectum (DCR) is the official journal of the American Society of Colon and Rectal Surgeons (ASCRS) dedicated to advancing the knowledge of intestinal disorders by providing a forum for communication amongst their members. The journal features timely editorials, original contributions and technical notes.
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