Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• Annals of surgery, 2019-11, Vol.270 (5), p.747-754

Ort / Verlag

United States

Erscheinungsjahr

2019

Quelle

MEDLINE

Beschreibungen/Notizen

• The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. 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. 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. 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). Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.