The Accrobat I Study: Three-Year Follow-Up of A Prospective Phase Ii Study with Neoadjuvant Tpf Before Bioradiotherapy for Stage Iii-Iv Unresectable Squamous Cell Head and Neck Cancer

e17004 Background: Concomittant cisplatinbased chemoradiotherapy increases tumour control compared to radiation alone. However, both acute and late toxicity can be important and the influence on rate of distant metastases is small. We exchanged cisplatin (P) for cetuximab (E) to reduce locoregional toxicity of external, mostly IMRT based radiotherapy, when possible boosted with brachytherapy (BT), and added neoadjuvant TPF to impact risk of peripheral metastases Methods: Patients (pts) with untreated stage III-IV , WHO 0-1, unresectable squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx had 2 cycles of TPF (docetaxel and cisplatin 75mg/m2 day 1, 5-FU 1000/m2 96 hours CI) every 3 weeks followed by RT (68Gy/4.5 weeks) with E given one week before (400mg/m2) and weekly during RT (250mg/m2). BT of 8-15 Gy completed RT for oral and oropharyngeal tumors (not tonsillar T1-2). Neck dissection was considered for N2-3 disease. Tumor response was evaluated according to RECIST with CT, MRI or PET/CT before RT and 6 weeks FU. Toxicity (CTC 3.0) and QL (EORTC QLQ 30) were registered during and after treatment. Results: From 070401 to 090731 90 pts were enrolled in the study and were analysed 3 year FU. Median age 58, males 72, oral cavity 9, oropharynx 58, larynx 10, hypopharynx 13, stage IV disease 76 , (T4 22, T4N+ 15). Remission after TPF: CR 8, PR 44, SD 26 and PD 1, not evaluated 11 (off study 2) Toxicity(acute): TPF cycles delayed 3, reduced 25, toxicity grade 5= 1 /90 pts (sepsis); E-cycles delayed 18, reduced 10, grade 3 hypersensitivity reaction 3/90, grade 3 neck dermatitis 3/90 pts. Alive NED 3 year FU 68/90pts (76%), DOD 7 (8%), dead intercurrent 6 (1 treatment related sepsis), alive with disease 7, lost FU 2. Toxicity (3 year): 3 pts; grade 3 dysphagia 2 (1 PEG), fatigue 1. Conclusions: Neoadjuvant TPF can be given before aggressive radiotherapy with cetuximab exchanged for cisplatin with manageable, mostly acute toxicities. Antitumor effects are promising with 3-year survival rate of 76%