1020PD - Concomitant Chemoradiotherapy (CT/RT) or CETUXIMAB/RT (CET/RT) with or Without Induction Docetaxel/Cisplatin/5-Fluorouracil (TPF) in Locally Advanced Head and Neck Cancer (LASCCHN). Preliminary Toxicity Results of a Randomized, 2x2 Factorial, Phase II-III Study. (NCT01086826)

Abstract

ABSTRACT Background CT/RT or CET/RT are standard treatment options for LASCCHN. Strategies to improve the efficacy with the integration of induction chemotherapy are being investigated. Primary endpoints of this study were to compare: 1) the 3 y overall survival (OS) of induction vs. no induction arms; 2) the Grade(G)3-4 in-field toxicity of CT/RT vs. CET/RT. Methods Patients (pts) with unresectable LASCCHN, stage III-IV, ECOG PS 0–1 were randomized to a 2x2 factorial design: Arm A1: CT/RT (2 cycles of ciplatin/5fluorouracil); Arm A2: CET/RT; Arm B1: 3 cycles of induction TPF followed by the same CT/RT; Arm B2: 3 cycles of induction TPF followed by CET/RT. A total of 204 deaths (420 ptsincluding the 101 randomized in the phase II part of the study comparing CT/RT with or w/o induction TPF) were required to detect a HR of death of 0.675 (A1 + A2 vs. B1 + B2; 2-sided a = 0.05; b = 0.20) and a 10% difference in G3-4 in-field mucosal toxicity (A1 + B1 vs. A2 + B2). Results Accrual was completed (421 pts) in April 2012. By May 2012, 348 patients were evaluable for toxicity during the planned concomitant treatments. 82% of pts were male; median age was 60y; PS of 0 (77.8%) or 1 (22.2%). Stage was III (31%) or IV (69%). Sites of disease were: oral cavity: 21.7%, oropharynx: 54.8%, hypopharynx: 23.5%. Data on G3-4 in-field toxicity (primary endpoint) and compliance to CT/RT vs CET/RT are shown in table 1. CT/RT N 215 CET/RT N 133 p In-field mucositis Grade 3 Grade 4 37% 4% 35% 2% 0.79 0.45 In-field skin reaction Grade 3 Grade 4 13% 1% 20% 1% 0.07 0.58 RT median dose, Gy (range) 70 (8-70) 70 (14-70) 0.32 RT median duration, weeks (range) 7 (1-13) 8 (1-14) Pts with RT interruption >3days 32% 38% 0.22 RT modification due to acute toxicity 37% 40% 0.58 Conclusions No advantage for CET/RT over CT/RT were observed regarding G3-4 in-field toxicities and feasibility. Pts are still being followed-up to assess OS. Table 1: Disclosure All authors have declared no conflicts of interest.