• Jérémie H Lefèvre, Laurent Mineur, Marine Cachanado, Quentin Denost, 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 Goasguen, Ben Creavin, Tabassome Simon, Yann Parc, and The French Research Group of Rectal Cancer Surgery (GRECCAR).
• Sorbonne Université, Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Paris, France.
• Ann. Surg. 2019 Nov 1; 270 (5): 747-754.

ObjectiveThe aim of this study was to report the 3-year survival results of the GRECCAR-6 trial.Summary Background DataCurrent 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.MethodsThe 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.ResultsA 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).ConclusionExtending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.

34 keywords...

hide…