Final Results of the GRECCAR-6 Trial on Waiting Period Following Neoadjuvant Radiochemotherapy for Locally Advanced Rectal Cancer: 5 Years of Follow-up.

Autor:	Collard MK; Department of General and Digestive Surgery, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Sorbonne Universités. 184 rue du Fbg St-Antoine, 75012 Paris, France., Mineur L; Oncology, Radiotherapy, Sainte-Camille Institut, 250 Chemin de Baigne Pieds, 84918 Avignon Cedex 9, France., Nekrouf C; Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris (URC-CRC-CRB), Assistance Publique Hôpitaux de Paris, Hôpital St Antoine, Paris., Denost Q; Bordeaux Colorectal Institute, Clinique Tivoli-Ducos, Bordeaux, France., Rouanet P; Department of Oncological Surgery, Val d'Aurelle Institut, 208 Avenue des Apothicaires, 34298 Montpellier, France., de Chaisemartin C; Department of Oncological Surgery, Paoli-Calmettes Institut, 232 Boulevard de Sainte-Marguerite, 13009 Marseille CHU, France., Merdrignac A; Department of Hepatobiliary and Digestive Surgery, CHU, 2 Rue Henri le Guilloux, 35000 Rennes, France., Jafari M; Department of Oncological Surgery, Oscar Lambret Center, 3 Rue Frédéric Combemale, 59000 Lille, France., Cotte E; Department of Digestive Surgery, CHU Lyon-Sud, 165 Chemin du Grand Revoyet, 69310 Pierre-Bénite, France., Desrame J; Department of Gastrology and Hepatology, Jean Mermoz Institut, 55 Avenue Jean Mermoz, 69008 Lyon, France., Manceau G; Department of Digestive and Hepatobiliary Surgery, CHU Pitié-Salpétrière, 91 Boulevard de l'Hopital, 75013 Paris, France., Benoist S; Department of Digestive and Oncological Surgery, CHU Bicètre, 78 Rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France., Buscail E; Department of Surgery, CHU Purpan, Place du Dr Joseph Baylac, 31400 Toulouse, France., Karoui M; Department of Digestive, Oncological and General Surgery, CHU HEGP, 20 Rue Leblanc, 75015 Paris, France., Panis Y; Colorectal Center, Groupe Hospitalier privé Ambroise Paré-Hartmann, Neuilly-sur-Seine, France., Piessen G; Department of Digestive Surgery, CHRU, 2 Avenue Oscar Lambret, 59000 Lille, France., Saudemont A; Department of Digestive Surgery and Transplant Surgery, CHRU, 2 Avenue Oscar Lambret, 59000 Lille, France., Prudhomme M; Department of Digestive and Oncological Surgery, CHU Carémeau, 4 Rue du Professeur Robert Debré, 30029 Nîmes, France., Peschaud F; Department of Digestive Surgery, CHU Ambroise-Paré, 9 Avenue Charles de Gaulle, 92100 Boulogne-Billancourt, France., Dubois A; Department of Digestive Surgery, CHU Estaing, 1 Rue Lucie Aubrac, 63100 Clermont-Ferrand, France., Loriau J; Department of Digestive Surgery, St-Joseph Hospital, 185 Rue Raymond Losserand, 75014 Paris, France., Tuech JJ; Department of Digestive Surgery, CHU, 1 Rue de Germont, 76000 Rouen, France., Duchalais E; Department of Digestive Surgery, Croix Saint-Simon Hospital, 12-18 Rue du Sergent Bauchat, 75012 Paris, France., Lupinacci R; Department of Digestive Surgery, CHU Hôtel-Dieu, 1 Place Alexis-Ricordeau, 44000 Nantes, France., Goasgen N; Department of General and Endocrine Surgery, Pitié Salpêtrière Hospital, APHP, Sorbonne University, 47-83 Boulevard de L'Hôpital, Paris, France., Simon T; Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris (URC-CRC-CRB), Assistance Publique Hôpitaux de Paris, Hôpital St Antoine, Paris., Parc Y; Department of General and Digestive Surgery, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Sorbonne Universités. 184 rue du Fbg St-Antoine, 75012 Paris, France., Lefevre JH; Department of General and Digestive Surgery, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Sorbonne Universités. 184 rue du Fbg St-Antoine, 75012 Paris, France.
Jazyk:	angličtina
Zdroj:	Diseases of the colon and rectum [Dis Colon Rectum] 2024 Nov 07. Date of Electronic Publication: 2024 Nov 07.
DOI:	10.1097/DCR.0000000000003477
Abstrakt:	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. (Copyright © The ASCRS 2024.)
Databáze:	MEDLINE
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