title: Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer.
abstract: OBJECTIVE
  Intensity-modulated radiation therapy (IMRT) has shown its interest for head and neck cancer treatment. In parallel, cetuximab has demonstrated its superiority against exclusive radiotherapy. The objective of this study was to assess the acute toxicity, local control and overall survival of cetuximab associated with different IMRT modalities compared to platinum-based chemotherapy and IMRT in the ARTORL study (NCT02024035).
  
  
  METHODS
  This prospective, multicenter study included patients with epidermoid or undifferentiated nasopharyngeal carcinoma, epidermoid carcinoma of oropharynx and oral cavity (T1-T4, M0, N0-N3). Acute toxicity, local control and overall survival were compared between groups (patients receiving cetuximab or not). Propensity score analysis at the ratio 1:1 was undertaken in an effort to adjust for potential bias between groups due to non-randomization.
  
  
  RESULTS
  From the 180 patients included in the ARTORL study, 29 patients receiving cetuximab and 29 patients treated without cetuximab were matched for the analysis. Ten patients (34.5%) reported acute dermal toxicity of grade 3 in the cetuximab group versus three (10.3%) in the non-cetuximab group obtained after matching (P=0.0275). Cetuximab was not significantly associated with more grade 3 mucositis (P=0.2563). There were no significant differences in cutaneous or oral toxicity for patients treated with cetuximab between the different IMRT modalities (P=1.000 and P=0.5731, respectively). There was no significant difference in local relapse-free survival (P=0.0920) or overall survival (P=0.4575) between patients treated with or without cetuximab.
  
  
  CONCLUSIONS
  Patients treated with cetuximab had more cutaneous toxicities, but oral toxicity was similar between groups. The different IMRT modalities did not induce different toxicity profiles.
authors.affiliation: Hôpital européen Georges-Pompidou, 20, rue Leblanc, 75015 Paris, France; Université Paris Descartes, Paris Sorbonne Cité, 12, rue de l'École-de-Médecine, 75006 Paris, France.
authors.forename: J-E
authors.initials: JE
authors.lastname: Bibault
authors.affiliation: CNRS UMR 5824, groupe d'analyse et de théorie économique (GATE)-LSE, maison de l'université, bâtiment B, 10, rue Tréfilerie, 42023 Saint-Étienne cedex 02, France; Université Claude-Bernard Lyon 1, 43, boulevard du 11-Novembre-1918, 69622 Villeurbanne cedex, France; Université Lumière Lyon 2, 18 quai Claude-Bernard, 69007 Lyon, France; Centre de lutte contre le cancer Léon-Bérard, 28, rue Laënnec, 69008 Lyon, France.
authors.forename: M
authors.initials: M
authors.lastname: Morelle
authors.affiliation: CNRS UMR 5824, groupe d'analyse et de théorie économique (GATE)-LSE, maison de l'université, bâtiment B, 10, rue Tréfilerie, 42023 Saint-Étienne cedex 02, France; Université Claude-Bernard Lyon 1, 43, boulevard du 11-Novembre-1918, 69622 Villeurbanne cedex, France; Université Lumière Lyon 2, 18 quai Claude-Bernard, 69007 Lyon, France; Centre de lutte contre le cancer Léon-Bérard, 28, rue Laënnec, 69008 Lyon, France.
authors.forename: L
authors.initials: L
authors.lastname: Perrier
authors.affiliation: Centre de lutte contre le cancer Léon-Bérard, 28, rue Laënnec, 69008 Lyon, France.
authors.forename: P
authors.initials: P
authors.lastname: Pommier
authors.affiliation: Institut régional de cancérologie de Montpellier, 208, avenue des Apothicaires, parc Euromédecine, 34298 Montpellier cedex 5, France.
authors.forename: P
authors.initials: P
authors.lastname: Boisselier
authors.affiliation: Centre Oscar-Lambret, 3, rue Frédéric-Combemale, 59000 Lille, France.
authors.forename: B
authors.initials: B
authors.lastname: Coche-Dequéant
authors.affiliation: Clinique Pasteur, 45, avenue de Lombez, 31300 Toulouse, France.
authors.forename: O
authors.initials: O
authors.lastname: Gallocher
authors.affiliation: Institut Sainte-Catherine, 250 chemin de Baigne-Pieds, 84918 Avignon cedex 9, France.
authors.forename: M
authors.initials: M
authors.lastname: Alfonsi
authors.affiliation: Centre René-Gauducheau, boulevard Jacques-Monod, 44805 Saint-Herblain, France.
authors.forename: É
authors.initials: É
authors.lastname: Bardet
authors.affiliation: Institut Claudius-Regaud, 20, rue du Pont-Saint-Pierre, 31052 Toulouse, France.
authors.forename: M
authors.initials: M
authors.lastname: Rives
authors.affiliation: Institut Curie, 26, rue d'Ulm, 75005 Paris, France.
authors.forename: V
authors.initials: V
authors.lastname: Calugaru
authors.affiliation: Centre Eugène-Marquis, avenue de la Bataille-Flandres-Dunkerque, 35000 Rennes, France.
authors.forename: E
authors.initials: E
authors.lastname: Chajon
authors.affiliation: Centre Paul-Strauss, 3, rue de la Porte-de-l'Hôpital, BP 30042, 67065 Strasbourg, France.
authors.forename: G
authors.initials: G
authors.lastname: Noël
authors.affiliation: Institut de cancérologie de Lorraine, centre Alexis-Vautrin, avenue de Bourgogne, 54511 Vandœuvre-Lès-Nancy, France.
authors.forename: H
authors.initials: H
authors.lastname: Mecellem
authors.affiliation: Centre de lutte contre le cancer Léon-Bérard, 28, rue Laënnec, 69008 Lyon, France.
authors.forename: D
authors.initials: D
authors.lastname: Pérol
authors.affiliation: Centre de lutte contre le cancer Léon-Bérard, 28, rue Laënnec, 69008 Lyon, France.
authors.forename: S
authors.initials: S
authors.lastname: Dussart
authors.affiliation: Hôpital européen Georges-Pompidou, 20, rue Leblanc, 75015 Paris, France; Université Paris Descartes, Paris Sorbonne Cité, 12, rue de l'École-de-Médecine, 75006 Paris, France. Electronic address: philippe.giraud@aphp.fr.
authors.forename: P
authors.initials: P
authors.lastname: Giraud
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy; D000068818:Cetuximab / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003875:Drug Eruptions / Q000209:etiology*; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000209:etiology*; D009364:Neoplasm Recurrence, Local; D057216:Propensity Score; D011446:Prospective Studies; D050397:Radiotherapy, Intensity-Modulated
chemical_list: D000970:Antineoplastic Agents; D000068818:Cetuximab
keywords: Carcinome tête et cou; Cetuximab; Contrôle local; Cétuximab; Efficacy; Head and neck cancer; Intensity-modulated radiation therapy; Radiothérapie conformationnelle avec modulation d’intensité; RapidArc; Survie globale; Tomotherapy; Tomothérapie; Toxicity; Toxicité; VMAT; Volumetric-modulated arc therapy