129831-144

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).

Subcategory: 
Category: 
Head and Neck Cancer
Session Type and Session Title: 
Oral Abstract Session, Head and Neck Cancer
Abstract Number: 
6004
Citation: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 6004)
Author(s): 
Maria Grazia Ghi, Adriano Paccagnella, Daris Ferrari, Paolo Foa, Maria Cossu Rocca, Elena Verri, Franco Morelli, Giuseppe Azzarello, Consuelo D'Ambrosio, Giorgio Cruciani, Monica Guaraldi, Elena Massa, Ciro Rossetto, Andrea Bonetti, Salvatore Siena, Vincenzo Minotti, Haralabos Koussis, Gabriella Pieri, Vittorio Baggio, Irene Floriani, for the GSTTC Italian Study Group; Medical Oncology Department, Venezia, Italy; Medical Oncology Unit, San Paolo Hospital, Milan, Italy; Medical Oncology, San Paolo Hospital, Milano, Italy; Medical Oncology Unit of Urogenital and Head and Neck Tumors- European Institute of Oncology, Milano, Italy; U.O.C. Oncologia, IRCCS Caa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; Department of Internal Medical Sciences,Oncology Unit ASL 13, Mirano, Italy; Oncology Department, Modena, Italy; Medicali Oncology Department, Azienda USL, Ravenna, Italy; Medical Oncology Department, Policlinico Sant'Orsola-Malpighi, Bologna, Italy; Dipartimento di Scienze Mediche Internistiche, Cagliari, Italy; Department of Oncology University Hospital - Udine, Udine, Italy; Department of Oncology, Mater Salutis Hospital-AULSS 21 della Regione Veneto, Legnago, Italy; Ospedale Niguarda Ca' Granda Milano, Milan, Italy; Division of Medical Oncology, Azienda Ospedaliera, Perugia, Italy; Istituto Oncologico Veneto - IRCCS, Padova, Italy; Oncology Department, Oncology Unit, Ospedali Riuniti di Trieste, Trieste, Italy; Division of Medical Oncology, Ospedale Cà Foncello, Treviso, Italy; Laboratory of Clinical Trials, Oncology Department, Istituto di Ricerche Farmacologiche, Milano, Italy

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

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.