996PCETUXIMAB RELATIVE DOSE INTENSITY (RDI) IN RECURRENT/METASTATIC (R/M) SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN): FIRST OBSERVATIONAL PROSPECTIVE STUDY IN UNSELECTED PATIENTS (DIRECT TRIAL)

ABSTRACT Aim: Cetuximab combined with platinum is the standard first-line therapy in patients (pts) with R/M SCCHN. DIRECT is the first multicenter prospective observational study evaluating cetuximab RDI in this setting. Methods: Pts were prospectively enrolled. No prior systemic therapy for R/M SCCHN was allowed. Pts received cetuximab in combination with platinum, according to the pivotal study EXTREME schedule, 5-FU if not contra-indicated and maintenance treatment with cetuximab every 2 weeks was allowed. The primary endpoint was the number of pts with cetuximab RDI >80%. Results: High quality of data was obtained by frequent monitoring of sites every 3 months (evaluable data in 93% of pts for baseline characteristics and in 89% of pts for cetuximab RDI). 154 pts were enrolled in 53 centres between 2012/11 and 2013/03: 86% male, median age 59 years, 81% with PS 80% in 68.5%, 64.7% and 93%, during chemotherapy (CT), CT + maintenance or maintenance periods respectively. Planned doses of cetuximab were decreased in 9.7% and delayed in 36% of 154 pts, mostly during CT. 97 pts (63.0%) withdrew the study for progression (48.5%), death (31%), toxicity (6%), lost to follow-up (1%), or other reasons (13.5%). Grade > 2 skin toxicities were observed in 9 (5.8%) pts. Conclusions: In unselected pts, RDI data in DIRECT study confirms the feasibility and the good tolerance of cetuximab combined with platinum previously reported in the pivotal trial. DIRECT study supports the use of cetuximab + CT as standard treatment in clinical practice. Disclosure: J. Guigay: Research funding : GSK; Merck Serono; Novartis Honoraria : Merck Serono; B. Petre-Lazar: Medical advisor: Merck Serono; F. Mornex, P. Ceruse, M. Alfonsi and C. Le Tourneau: Honoraria : Merck Serono; A. Berrier: Research funding : Merck Serono; S. Faivre: membership advisory board : Merck Serono Honoraria : Merck Serono Research funding: Merck Serono; F. Rolland: Honoraria : Merck Serono Expert Testimony : Merck Serono. All other authors have declared no conflicts of interest.