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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).
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
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.
Abstracts by Maria Grazia Ghi:
A phase II-III study comparing concomitant chemoradiotherapy (CRT) versus cetuximab/RT (CET/RT) with or without induction docetaxel/cisplatin/5-fluorouracil (TPF) in locally advanced head and neck squamous cell carcinoma (LASCCHN): Efficacy results (NCT01086826).Meeting: 2013 ASCO Annual Meeting | Abstract No: 6003
Cetuximab/radiotherapy (CET+RT) versus concomitant chemoradiotherapy (cCHT+RT) with or without induction docetaxel/cisplatin/5-fluorouracil (TPF) in locally advanced head and neck squamous cell carcinoma (LASCCHN): Preliminary results on toxicity of a randomized, 2x2 factorial, phase II-III study (NCT01086826).Meeting: 2012 ASCO Annual Meeting | Abstract No: 5513
Presentations by Maria Grazia Ghi:
Concomitant CRT or Cetuximab/RT Versus Induction Docetaxel/Cisplatin/5-FU (TPF) Followed by CRT or Cetuximab/RT in Patients with LASCCHN: A Randomized Phase III Factorial Study - Efficacy Results (NCT01086826)Meeting: 2014 ASCO Annual Meeting Abstract No: 6004Session: Head and Neck Cancer (Oral Abstract Session)