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J Clin Oncol. 2018 Jul 17:JCO2017762591. doi: 10.1200/JCO.2017.76.2591. [Epub ahead of print]

Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial.

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1
Lionnel Geoffrois, Marie-Christine Kaminsky, Institut de Cancérologie de Lorraine, Vandoeuvre Lès Nancy; Laurent Martin, Centre Guillaume le Conquérant; Dominique De Raucourt, Bernard Gery, Centre François Baclesse; Emmanuel Babin, Hopital Universitaire, Caen; Xu Shan Sun, Joëlle Buffet, Centre Hospitalier Universitaire de Besançon, Besançon; Hôpital de Mulhouse, Mulhouse; Yungan Tao, Gustave-Roussy Institute, Villejuif; Philippe Maingon, Centre François Leclercq, Leclercq; Yoann Pointreau, Cédric Lafond, Marie-Hélène Calais, Pascal Garaud, Centre Jean Bernard, Le Mans; Centre Hospitalier Universitaire de Tours, Tours; Christian Sire, Centre Hospitalier de Lorient, Lorient; Claude Tuchais, Eric Jadaud, Centre Paul Papin, Angers; Alexandre Coutte, Centre Hospitalier Universitaire Amiens, Amiens; Frédéric Rolland, Centre René Gauducheau, Saint Herblain; Marc Alfonsi, Clinique Sainte Catherine, Avignon; Michel Lapeyre, Centre Jean Perrin, Clermont; Marie Saliou, Clinique Mutualiste, Saint Nazaire; Ayman Zawadi, Centre Hospitalier de La Roche-sur-Yon, La Roche-sur-Yon; Jean-Marc Tourani, Centre Hospitalier Universitaire, Poitiers, Poitiers; Cédric Khoury, Centre Saint Louis; Pierre Guillet, Hôpital Font-Pré, Toulon, Toulon; Ali Hasbini, Hopital de Saint Brieuc, Saint Brieuc; François Guichard, Polyclinique de Bordeaux-Nord, Bordeaux; Christian Borel, Centre Paul Strauss, Strasbourg, France; Anne Rose Henry, Hôpital Montigny le Tilleul, Montigny-le-Tilleul; Nicolas Meert, Centre Hospitalier de Charlebois, Charlebois, Belgium; and Jean Bourhis, Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, Switzerland.

Abstract

Purpose Both concurrent chemoradiotherapy (CT-RT) and cetuximab radiotherapy (cetux-RT) have been established as the standard of care for the treatment of locally advanced squamous cell carcinoma of the head and neck. It was not known whether the addition of induction chemotherapy before cetux-RT could improve outcomes compared with standard of care CT-RT. Patients and Methods The current trial was restricted to patients with nonmetastatic N2b, N2c, or N3 squamous cell carcinoma of the head and neck and fit for taxotere, cisplatin, fluorouracil (TPF). Patients were randomly assigned to receive three cycles of TPF followed by cetux-RT versus concurrent carboplatin fluorouracil and RT as recommended in National Comprehensive Cancer Network guidelines. The trial was powered to detect a hazard ratio (HR) of 0.66 in favor of TPF plus cetux-RT for progression-free survival at 2 years. The inclusion of 180 patients per arm was needed to achieve 80% power at a two-sided significance level of .05. Results Between 2009 and 2013, 370 patients were included. All patients and tumors characteristics were well balanced between arms. There were more cases of grade 3 and 4 neutropenia in the induction arm, and the induction TPF was associated with 6.6% treatment-related deaths. With a median follow-up of 2.8 years, 2-year progression-free survival was not different between both arms (CT-RT, 0.38 v TPF + cetux-RT, 0.36; HR, 0.93 [95% CI, 0.73 to 1.20]; P = .58). HR was 0.98 (95% CI, 0.74 to 1.3; P = .90) for locoregional control and 1.12 (95% CI, 0.86 to 1.46; P = .39) for overall survival. These effects were observed regardless of p16 status. The rate of distant metastases was lower in the TPF arm (HR, 0.54 [95% CI, 0.30 to 0.99]; P = .05). Conclusion Induction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.

PMID:
30016178
DOI:
10.1200/JCO.2017.76.2591

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