1035PINDUCTION CHEMOTHERAPY (ICT) WITH DOCETAXEL/CISPLATIN/5-FLUOROURACIL (T/P/F) FOLLOWED BY CHEMORADIOTHERAPY WITH CISPLATIN (CRTP) VS BIORADIOTHERAPY WITH CETUXIMAB (RTCX) FOR UNRESECTABLE LOCALLY ADVANCED HEAD & NECK CANCER (ULAHNC): PRELIMINARY RESULTS ON TOXICITY A TTCC GROUP TRIAL

ABSTRACT Background: ICT with taxanes regimens has been demonstrate increase overall survival (OS) in the recent metaanalysis (Blanchard JCO 2013) in patients (pts) with LAHNC. However CRTP or RTCx hasnt be compared as consolidation treatment. This randomized phase III trial (TTCC-2007-01, NCT00716391) compared OS and not inferiority of RTCx respect to CRTP. Now, we report preliminary results of toxicity in both regimen. Methods: Eligible pts: unresectable tumors, measurable disease, adequate organ function, ECOG 0–1. Treatment: T 75 mg/m2 d1, P 75 mg/m2 d1, F 750 mg/m2 CI d 1–5 q 21 d + G-CSF & ciprofloxacin, by 3 cycles; then, they were randomized to: conventional radiotherapy (RT) up to 70 Gy + P 100 mg/m2 d 1–22-43 vs conventional RT up to 70 Gy + cetuximab 400/250 mg/m2 weekly until the completion of RT, and they were stratified by primary tumor site (TS). Surgery after RT (neck dissection) was allowed. Results: By July 2008, 516 pts over 531 were evaluable for toxicity; 89% male, 99,8% caucasian, median age: 57y (29–73), PS: 0 = 25.7%, 1 = 70.5%. Disease stage: III: 8,1% - IV: 90,5%. TS: oropharynx: 37.2%, hypopharynx: 20.7%, larynx: 14,3% and oral cavity: 12.8%. Median follow-up: 8,9 months, 197 deaths occurred. G3-4 toxicity: TPF neutropenia: 9,1%, febrile neutropenia (FN): 12,6%, non-hematological toxicity (NHT): 15,9%, toxic death: 2,13%. CRTP: anemia 1,4%, neutropenia 4,9%, FN 1,4%, NHT: 11,2%, mucosal and gastrointestinal toxicity were the most common, toxic death: 0,78%. RTCx: anemia 0,2%,neutropenia 0%, FN: 0,2%, NHT: 19,2%, cutaneous and mucosal toxicity were the most common disorders, toxic death: 0,78%. SAEs: CRTP 8,3%, RTCx: 4,5%. Conclusions: Interim data suggest that ICT is tolerable in ULAHNC. RTCx seems to have less haematological side effects than CRTP, and decreases the rate of SAEs. There's a trend of less gastrointestinal and renal toxicity with RTCx, and less dermatological toxicity and radiation-induced skin injury with CRTP. Currently ongoing to further evaluate efficacy and OS. Disclosure: R. Hitt, R. Mesia and J.J. Cruz Hernandez: This trial was funded by Sanofi Aventis and Merck. Consultant, advisory board and expert testimony compensated by Sanofi Aventis and Merck; J.J. Grau, J. Rubio, J. Martinez-Trufero, E. Del Barco Morillo, C. Garcia-Giron, S. Vazquez, B. Cirauqui, M. Pastor Borgonon, E. Galve Calvo, O. Juan-Vidal, R. Lopez, J. Martinez-Galan, R. Bastus and A. Berrocal: This trial was funded by Sanofi Aventis and Merck.All other authors have declared no conflicts of interest.