GORTEC 2007-01
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.
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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).
