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

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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Yungan Tao
  • Fonction : Auteur
Anne Auperin
  • Fonction : Auteur
Christian Sire
  • Fonction : Auteur
Laurent Martin
  • Fonction : Auteur
Cedric Khoury
  • Fonction : Auteur
Philippe Maingon
Etienne Bardet
  • Fonction : Auteur
Marie-Christine Kaminsky
  • Fonction : Auteur
Michel Lapeyre
  • Fonction : Auteur
Thierry Chatellier
  • Fonction : Auteur
Marc Alfonsi
  • Fonction : Auteur
Yoann Pointreau
  • Fonction : Auteur
Eric Jadaud
  • Fonction : Auteur
Bernard Gery
  • Fonction : Auteur
Ayman Zawadi
  • Fonction : Auteur
Jean-Marc Tourani
  • Fonction : Auteur
Brigitte Laguerre
  • Fonction : Auteur
Severine Racadot
  • Fonction : Auteur
Ali Hasbini
  • Fonction : Auteur
Emanuelle Malaurie
  • Fonction : Auteur
Christian Borel
  • Fonction : Auteur
Nicolas Meert
  • Fonction : Auteur
Alexandre Cornely
  • Fonction : Auteur
Nathalie Ollivier
  • Fonction : Auteur
Odile Casiraghi
  • Fonction : Auteur
Xu Shan Sun
  • Fonction : Auteur
Jean Bourhis
  • Fonction : Auteur

Résumé

PurposeTo 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 MethodsIn 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.ResultsFour 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).ConclusionThe 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.
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Dates et versions

hal-03600477 , version 1 (07-03-2022)

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Citer

Yungan Tao, Anne Auperin, Christian Sire, Laurent Martin, Cedric Khoury, et al.. 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. Journal of Clinical Oncology, 2018, 36 (31), pp.3084+. ⟨10.1200/JCO.2017.76.2518⟩. ⟨hal-03600477⟩

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