J-E Bibault1, M Morelle2, L Perrier2, P Pommier3, P Boisselier4, B Coche-Dequéant5, O Gallocher6, M Alfonsi7, É Bardet8, M Rives9, V Calugaru10, E Chajon11, G Noël12, H Mecellem13, D Pérol3, S Dussart3, P Giraud14. 1. 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. 2. 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. 3. Centre de lutte contre le cancer Léon-Bérard, 28, rue Laënnec, 69008 Lyon, France. 4. Institut régional de cancérologie de Montpellier, 208, avenue des Apothicaires, parc Euromédecine, 34298 Montpellier cedex 5, France. 5. Centre Oscar-Lambret, 3, rue Frédéric-Combemale, 59000 Lille, France. 6. Clinique Pasteur, 45, avenue de Lombez, 31300 Toulouse, France. 7. Institut Sainte-Catherine, 250 chemin de Baigne-Pieds, 84918 Avignon cedex 9, France. 8. Centre René-Gauducheau, boulevard Jacques-Monod, 44805 Saint-Herblain, France. 9. Institut Claudius-Regaud, 20, rue du Pont-Saint-Pierre, 31052 Toulouse, France. 10. Institut Curie, 26, rue d'Ulm, 75005 Paris, France. 11. Centre Eugène-Marquis, avenue de la Bataille-Flandres-Dunkerque, 35000 Rennes, France. 12. Centre Paul-Strauss, 3, rue de la Porte-de-l'Hôpital, BP 30042, 67065 Strasbourg, France. 13. Institut de cancérologie de Lorraine, centre Alexis-Vautrin, avenue de Bourgogne, 54511 Vandœuvre-Lès-Nancy, France. 14. 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.
Abstract
PURPOSE: 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). PATIENTS AND METHOD: 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. CONCLUSION: 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.
PURPOSE: 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). PATIENTS AND METHOD: 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. CONCLUSION: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: Yock Ping Chow; Lu Ping Tan; San Jiun Chai; Norazlin Abdul Aziz; Siew Woh Choo; Paul Vey Hong Lim; Rajadurai Pathmanathan; Noor Kaslina Mohd Kornain; Chee Lun Lum; Kin Choo Pua; Yoke Yeow Yap; Tee Yong Tan; Soo Hwang Teo; Alan Soo-Beng Khoo; Vyomesh Patel Journal: Sci Rep Date: 2017-03-03 Impact factor: 4.379