학술논문
Does A Longer Waiting Period After Neoadjuvant Radio-chemotherapy Improve the Oncological Prognosis of Rectal Cancer?: Three Years’ Follow-up Results of the Greccar-6 Randomized Multicenter Trial
Document Type
Academic Journal
Author
Lefèvre, Jérémie H.; Mineur, Laurent; Cachanado, Marine; Denost, Quentin; Rouanet, Philippe; de Chaisemartin, Cécile; Meunier, Bernard; Mehrdad, Jafari; Cotte, Eddy; Desrame, Jérome; Karoui, Mehdi; Benoist, Stéphane; Kirzin, Sylvain; Berger, Anne; Panis, Yves; Piessen, Guillaume; Saudemont, Alain; Prudhomme, Michel; Peschaud, Frédérique; Dubois, Anne; Loriau, Jérome; Tuech, Jean-Jacques; Meurette, Guillaume; Lupinacci, Renato; Goasguen, Nicolas; Creavin, Ben; Simon, Tabassome; Parc, Yann
Source
Annals of Surgery. Nov 01, 2019 270(5):747-754
Subject
Language
English
ISSN
0003-4932
Abstract
OBJECTIVE:: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. SUMMARY BACKGROUND DATA:: Current data on the effect of an extended interval between radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown. METHODS:: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had received RCT (45–50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates. RESULTS:: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent a mesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ± 8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS (P = 0.8868) or DFS (P = 0.9409). Distant (P = 0.7432) and local (P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1 mm [hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17–3.51], ypT3-T4 (HR = 2.69; 95% CI, 1.19–6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89–6.91). CONCLUSION:: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.