TPF plus cetuximab (E) induction chemotherapy (ICT) followed by biochemoradiation (BCRT) with weekly E plus weekly cisplatin (P) or carboplatin (C) in stage III/IV squamous cell carcinoma of the head and neck (HNSCC): A randomized phase II EORTC trial.

Abstract

6076Background: To test the safety of BCRT with P and C after TPF-E. Methods: Stage III/IV unresectable, HNSCC pts received up to 4 cycles (cy) of TPF-E (P and docetaxel [D] 75 mg/m² d 1, 5-FU 750 mg/m²/d d1-5, cetuximab [E, 400/250 mg/m²/wk]), with prophylactic antibiotics, no G-CSF. Pts with no PD after 4 cy were randomly assigned to BCRT (70 Gy/7 weeks/2 Gy fractions), weekly E, with either P 40 mg/m²/wk or C AUC 1.5/wk. Primary endpoint: feasibility of BCRT ( > 80% dose intensity (DI) of RT, P or C, and E). Results: 46 patients started TPF-E, 30 started BCRT. Median age: 57 (48-72), 41 male. WHO 0/1: 29/17. Stage III/IV: 4/42. 4 oral cavity, 24 oropharynx, 12 hypopharynx, 4 larynx, 2 unknown. 34, 4, 6, 2 pts received 4,3,2, and 1 TPF-E cy. Median DI (mg/m²/wk): D: 24.4, P: 24.4, 5-FU: 1220.9, E: 255.4. ICT was discontinued in 12 pts (6 toxicity [1 grade 5], 1 protocol violation, 2 medical decision, 1 pt refusal, 1 death [cause unknown], 1 cerebrovascular accident). 3 were not randomized: 1 PD under IC...