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 - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2018

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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Lionnel Geoffrois
  • Fonction : Auteur
Laurent Martin
  • Fonction : Auteur
Dominique de Raucourt
  • Fonction : Auteur
Xu Shan Sun
  • Fonction : Auteur
Yungan Tao
  • Fonction : Auteur
Philippe Maingon
Joelle Buffet
  • Fonction : Auteur
Yoann Pointreau
  • Fonction : Auteur
Christian Sire
  • Fonction : Auteur
Claude Tuchais
  • Fonction : Auteur
Emmanuel Babin
  • Fonction : Auteur
Frederic Rolland
  • Fonction : Auteur
Marie-Christine Kaminsky
  • Fonction : Auteur
Marc Alfonsi
  • Fonction : Auteur
Michel Lapeyre
  • Fonction : Auteur
Marie Saliou
  • Fonction : Auteur
Cedric Lafond
  • Fonction : Auteur
Eric Jadaud
  • Fonction : Auteur
Bernard Gery
  • Fonction : Auteur
Ayman Zawadi
  • Fonction : Auteur
Jean-Marc Tourani
  • Fonction : Auteur
Cedric Khoury
  • Fonction : Auteur
Anne Rose Henry
  • Fonction : Auteur
Ali Hasbini
  • Fonction : Auteur
Francois Guichard
  • Fonction : Auteur
Christian Borel
  • Fonction : Auteur
Nicolas Meert
  • Fonction : Auteur
Pierre Guillet
  • Fonction : Auteur
Marie-Helene Calais
  • Fonction : Auteur
Pascal Garaud
  • Fonction : Auteur
Jean Bourhis
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Résumé

PurposeBoth 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 MethodsThe 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.ResultsBetween 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).ConclusionInduction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.

Dates et versions

hal-03600476 , version 1 (07-03-2022)

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Lionnel Geoffrois, Laurent Martin, Dominique de Raucourt, Xu Shan Sun, Yungan Tao, et al.. 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. Journal of Clinical Oncology, 2018, 36 (31), pp.3077+. ⟨10.1200/JCO.2017.76.2591⟩. ⟨hal-03600476⟩

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