S34 4th ICHNO median cancer specific survival from the end of RT was 21.9 months (95% CI: 13 – 31) for the CTX/RT group and 69.1 months (95% CI: 0 – 143) for the CDDP group (p=0.194). Conclusions: In this non-randomized study of LAHNC patients, there was no statistical difference in survival rates between patients treated with CTX/RT compared to CDDP/RT. There was an increased rate of PEG tube dependence in the CTX/RT group although this was non- statistically significant. PO-080 CETUXIMAB (CTX) IN RECURRENT AND METASTATIC HEAD AND NECK SQUAMOUS-CELL CARCINOMA (HN SCC) Ñ OUR EXTREME EXPERIENCE E. Gouveia 1 , D. Costa 1 , S. Esteves 2 , M. Ferreira 1 , A. Moreira 1 1 Instituto Português de Oncologia Francisco Gentil, Medical Oncology, Lisboa, Portugal 2 Instituto Português de Oncologia Francisco Gentil, Clinical Trials Department, Lisboa, Portugal Purpose/Objective: Cetuximab (CTX) blocks the epidermal- growth-factor-receptor and enhances the antitumor effects of chemotherapy (CT). CTX improves overall survival (OS) when given as first-line treatment (TT) in combination with platinum–fluorouracil CT in recurrent or metastatic head and neck squamous-cell carcinoma (HN SCC). Materials and Methods: Efficacy and toxicity of CTX plus platinum-based CT was retrospectively analyzed in patients (pts) with recurrent and/or metastatic HN SCC treated with CTX and CT between January 2009 and January 2012. Pts received cisplatin (CDDP) 100mg/m2 d1 or carboplatin (CBPL) AUC = 5 d1 plus 5-fluoruracil (5FU) 1000mg/m2 d1-4 continuous infusion every 3 weeks, CTX 400 mg/m2 week 1/ 250 mg/m2 weekly. Pts with stable disease continued to receive CTX until disease progression, unacceptable toxic effects or death. The primary endpoints were OS, estimated using Kaplan-Meier methodology, and toxicity. Results: 38 pts were evaluated with a mean age of 55.6 years [41-72], mostly male (84%), with a pre-treatment ECOG performance status (PS) between 0-1 (65.7%) and 2 (34.3%). Primary sites at diagnosis were: oral cavity (18.4%), oropharynx (23.7%), hypopharynx (13.2%), larynx (23.7%), multiple locations (18.4%) and occult primary (2.6%). Most pts presented with stage IV disease at diagnosis (IVA – 55.3%; IVB – 10.5%; IVC – 7.9%). At recurrence 18% had only loco-regional (LR) disease and 82% presented with metastatic disease (mainly pulmonary) with or without LR disease. Median OS was 5.3 months (95% confidence interval, 3.87 to 10.10 months) with a median follow-up for the total sample of 4.1 months. Most common adverse events were: rash (n=20), mucositis (n=12) and haematological toxicity (n=13). Grade 3 skin reactions were seen in 3 pts (7.9%). There were no sepsis or infusion-related reactions associated with CTX or grade 4 toxicity. Twenty-seven pts (71%) died in follow-up, but no CTX-related deaths were seen. Conclusions: In our group of pts with metastatic and/or recurrent HN SCC treated with CTX and platinum based CT, CTX was well tolerated with no serious toxicities, including septic shock and no toxic deaths. More than one third had a baseline PS of 2 (34.3%), 82% presented with metastatic disease (with or without LR disease) and 58% of patients received previous systemic CT. Longer follow-up and more pts are mandatory to obtain more concrete conclusions in terms of OS and progression–free survival. POSTER: ACUTE AND LATE TOXICITY PO-081 LATE TOXICITY AFTER RADICAL TREATMENT FOR LOCALLY ADVANCED HEAD-AND-NECK CARCINOMAS. M. Taberna 1 , C. Hierro 1 , M. Diez 1 , M. Olivera 1 , S. Vázquez 1 , V. Navarro 2 , M. Mañós 3 , A. Lozano 4 , E. Vilajosana 5 , R. Mesía 1 1 Institut Català d'Oncologia, Medical Oncology, Hospitalet/Barcelona, Spain 2 Institut Català d'Oncologia, Clinical Research Unit, Hospitalet/Barcelona, Spain 3 Hospital Universitari de Bellvitge, ENT, Hospitalet/Barcelona, Spain 4 Institut Català d'Oncologia, Radiation Oncology, Hospitalet/Barcelona, Spain 5 Institut Català d'Oncologia, Specialist Nurse in Head and Neck Cancer, Hospitalet/Barcelona, Spain Purpose/Objective: Modification of RT schedules and the addition of CT and biologics in patients (pts) with locally advanced head-and-neck carcinomas (LAHNC) have resulted in improving loco-regional control and survival, although this means increased morbidity. Our aim was to analyze late toxicity associated with these treatments. We also asked all the pts about the implications of their toxicity in their quality of life. Materials and Methods: Between March 1994 and July 2010, 128 pts with LAHNC were treated radically at our institution. We prospectively reviewed consecutive long-term survivors in an outpatient clinic, answering a subjective assessment of late toxicity based on the RTOG scoring system. We analyzed late toxicities in pts alive with more than 2 years of follow-up and their correlation with pt, tumor and therapies characteristics. Logistic regressions (logit link) for moderate and severe toxicity were performed to detect toxicity factors and p-values (p-val) and confidence intervals at 95 % level (CI) were obtained. Results: There were 111 men, median age 62 yrs (range 29- 81), with 102 (80%) squamous carcinomas , 33 (26%) oropharynx, 30 (23%) larynx, 23 (18%) cavum, 16 (13%) hipopharynx, 15 (12%) oral cavity, 11 (8%) others. 75 pts (58%) had received neoadjuvant CT (28 (37%) with PF-like, 27 (36%) TPF, 14 (19%) PPF, 6 (8%) others)) followed by concomitant treatment. Concomitant radical treatment was conducted in 44 pts (34%) ,(32 (73%) CDDP, 6 (14%) cetuximab and 6 (14%) others). Adjuvant CT-RT was delivered in 9 (7%) pts (8 (89%) CDDP-like). All 128 pts completed RT (102 (80%) normofractionated, 21 (16%) hyperfractionated and 1 (0.8%) hypofractionated), with a median dose of 70 Gy (range 50- 80). All pts had at least one grade 1-2 late toxicity, it is showed in Table 1. Furthermore, 34 (27%) pts experienced grade 3-4 toxicity, 8 (6%) having a permanent tracheostomy and 6 (5%) a permanent gastrostomy, 13 (10%) having speech pathology, 2 (2%) having sticky saliva, 4 (2%) having ototoxicity and 4 (3%) jaw’s osteonecrosis. Concomitant chemorradiation with cisplatin was found to be a risk factor of a moderate and severe late toxicity compared to concomitant cetuximab in the adjusted analysis by RT fraction: Moderate toxicity OR 0.38 (CI:0.152-0.949, p- val=0,038) and severe toxicity OR 0.285 (CI:0.081-0.995 ,p- val=0,049). 78% pts felt their quality of life as little or no disabling.