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J Clin Oncol. 2018 Jun 7:JCO2017762518. doi: 10.1200/JCO.2017.76.2518. [Epub ahead of print]

Improved Outcome by Adding Concurrent Chemotherapy to Cetuximab and Radiotherapy for Locally Advanced Head and Neck Carcinomas: Results of the GORTEC 2007-01 Phase III Randomized Trial.

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1
Yungan Tao, Anne Auperin, Alexandre Cornely, Nathalie Ollivier, Odile Casiraghi, and Jean Bourhis, Gustave-Roussy Institute, Villejuif; Christian Sire, Centre Hospitalier de Lorient, Lorient; Laurent Martin, Centre Guillaume le Conquérant, Le Havre; Cedric Khoury, Centre Hospitalier de Toulon, Toulon; Philippe Maingon, Centre Georges-François Leclerc, Dijon; Etienne Bardet, Centre René Gauducheau, Nantes; Marie-Christine Kaminsky, Centre Alexis Vautrin, Nancy; Michel Lapeyre, Centre Jean Perrin, Clermont; Thierry Chatellier, Clinique Mutualiste, Saint Nazaire; Marc Alfonsi, Clinique Sainte Catherine, Avignon; Yoann Pointreau, Centre Jean Bernard, Le Mans; Yoann Pointreau, Centre Hospitalier Universitaire (CHU) de Tours, Tours; Eric Jadaud, Centre Paul Papin, Angers; Bernard Géry, Centre François Baclesse, Caen; Ayman Zawadi, Centre Hospitalier de La Roche-sur-Yon, La Roche-sur-Yon; Jean-Marc Tourani, CHU, Poitiers; Brigitte Laguerre, Centre Eugène Marquis, Rennes; Alexandre Coutte, CHU, Amiens; Séverine Racadot, Centre Léon Bérard, Lyon; Ali Hasbini, Clinique Armoricaine, Saint-Brieuc; Emanuelle Malaurie, Centre Hospitalier Intercommunal de Créteil, Créteil; Christian Borel, Centre Paul Strauss, Strasbourg; Xu Shan Sun, Hopital Nord Franche-Comté de Montbéliard, Montbéliard; Xu Shan Sun, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France; Nicolas Meert, Centre Hospitalier de Charleroi, Charleroi, Belgium; and Jean Bourhis, Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, Switzerland.

Abstract

Purpose To investigate the effect of adding concurrent chemotherapy (CT) to cetuximab plus radiotherapy (RT; CT-cetux-RT) compared with cetuximab plus RT (cetux-RT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Patients and Methods In this phase III randomized trial, patients with N0-2b, nonoperated, stage III or IV (nonmetastatic) LA-SCCHN were enrolled. Patients received once-daily RT up to 70 Gy with weekly cetuximab or with weekly cetuximab and concurrent carboplatin and fluorouracil (three cycles). To detect a hazard ratio (HR) of 0.64 for progression-free survival (PFS) with 85% power at a two-sided significance level of P = .05, 203 patients needed to be included in each arm. Results Four hundred six patients were randomly assigned to either CT-cetux-RT or cetux-RT. Patient and tumor characteristics were well balanced between arms, including p16 status. With a median follow-up of 4.4 years, the HR for PFS favored the CT-cetux-RT arm (HR, 0.73; 95% CI, 0.57 to 0.94; P = .015), with 3-year PFS rates of 52.3% and 40.5% and median PFS times of 37.9 and 22.4 months in the CT-cetux-RT and cetux-RT arms, respectively. The HR for locoregional control was 0.54 (95% CI, 0.38 to 0.76; P < .001) in favor of CT-cetux-RT. These benefits were observed regardless of p16 status for oropharynx carcinomas. Overall survival (HR, 0.80; P = .11) and distant metastases rates (HR, 1.19; P = .50) were not significantly different between the two arms. The CT-cetux-RT arm, compared with cetux-RT, had a higher incidence of grade 3 or 4 mucositis (73% v 61%, respectively; P = .014) and of hospitalizations for toxicity (42% v 22%, respectively; P < .001). Conclusion The addition of concurrent carboplatin and fluorouracil to cetux-RT improved PFS and locoregional control, with a nonsignificant gain in survival. To our knowledge, this is the first evidence of a clinical benefit for treatment intensification using cetux-RT as a backbone in LA-SCCHN.

PMID:
29878867
DOI:
10.1200/JCO.2017.76.2518

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