Essai randomisé multicentrique de phase III évaluant l'apport d'une chimiothérapie concomitante chez les patients traités par radiothérapie - Erbitux pour un carcinome localement évolué des VADS <= N2a.
Coordinateur : Pr BOURHIS - Date de début : 2008 - Nb Patients 406 - publié
patients with N0-2b, nonoperated, stage III or IV (nonmetastatic)
the HR for PFS favored the CT-cetux-RT arm (HR, 0.73; 95% CI, 0.57 to 0.94; P = .015), with 3-year PFS rates of 52.3% and 40.5% and median PFS times of 37.9 and 22.4 months in the CT-cetux-RT and cetux-RT arms, respectively.
The HR for locoregional control was 0.54 (95% CI, 0.38 to 0.76; P , .001) in favor of CT-cetux-RT.
These benefits were observed regardless of p16 status for oropharynx carcinomas.
Overall survival (HR, 0.80; P = .11) and distant metastases rates (HR, 1.19; P = .50) were not significantly different between the two arms.
The CT-cetux-RT arm, compared with cetux-RT, had a higher incidence of grade 3 or 4 mucositis (73% v 61%, respectively; P = .014) and of hospitalizations for toxicity (42% v 22%, respectively; P , .001).
Tao Y, Auperin A, Sire C, Martin L, Khoury C, Maingon P, et al.
Improved Outcome by Adding Concurrent Chemotherapy to Cetuximab and Radiotherapy for Locally Advanced Head and Neck Carcinomas: Results of the GORTEC 2007-01 Phase III Randomized Trial.
J Clin Oncol. 7 juin 2018;JCO2017762518.