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Concomitant chemoradiation (CRT) or cetuximab/RT (CET/RT) versus induction Docetaxel/ Cisplatin/5-Fluorouracil (TPF) followed by CRT or CET/RT in patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN). A randomized phase III factorial study (NCT01086826).
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2014
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Surgical OncologyInduction TpfPharmacotherapyOral CancerRadiation MedicineOncologyNeck OncologyRadiation OncologyCancer ResearchTpf InductionRadiologyHealth SciencesRadiation TherapyPlatinum-based CrtCancer TreatmentPharmacologyHead And Neck CancerConcomitant ChemoradiationMedicine
6004 Background: Platinum-based CRT is the standard treatment for LASCCHN. CET/RT is superior to RT alone and it is an alternative treatment to CRT. Induction TPF resulted to be superior to cisplatin/5fluorouracil but its efficacy when added to concomitant treatment is to be demonstrated. We designed this open-label multicenter 2x2 factorial study to assess 2 primary endpoints: 1) overall survival (OS) of induction vs. no induction; 2) Grade 3-4 in-field mucosal toxicity of CRT vs. CET/RT (already presented at ASCO 2013). Methods: 421 patients with LASCCHN of the oral cavity, oropharynx, hypopharynx, stage III-IV, ECOG PS 0-1 were randomized to one of four treatment options: Arm A1: CRT (cisplatin/5fluorouracil x 2 concomitant to standard RT fractionation); Arm A2: CET/RT; Arm B1: 3 cycles of TPF followed by the same CRT; Arm B2: 3 cycles of TPF followed by CET/RT. The superiority hypothesis of OS comparison of TPF induction vs. no induction (Arms B1+B2 vs. A1+A2), requires 204 deaths to detect a relative reduction of 33% with 2-sided 5% significance level for the log-rank test and a power of 80%. Results: 415 out of 421 patients (six major violations) were finally analyzed: 207 in induction and 208 in concomitant arm. By march 2014, at a median follow-up of 41.3 months (mos), 243 events for PFS and 201 deaths were observed. Radiological CR was 43.5% in induction and 28% in concomitant arm (p=0.002) Median PFS was 29.7 mos in induction vs 18.5 in concomitant arm with a 3-year PFS of 46.8% vs 36.7% (HR:0.73; 95%CI 0.57-0.94; p=0.015), respectively. Median OS was 53.7 mos in induction vs 30.3 in concomitant arm with a 3-year OS of 57.6% vs 45.7% (HR:0.72; 95%CI 0.55-0.96; p=0.025) respectively. Compliance to concomitant treatments was not affected by induction TPF. Conclusions: Induction TPF followed by CRT or CET/RT significantly improved PFS and OS (independently from the type of concomitant strategy) in LASCCHN patients without compromising compliance to the concomitant treatments. Clinical trial information: NCT01086826.