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2. Early surgery for failure after chemoradiation in operable thoracic oesophageal cancer. Analysis of the non-randomised patients in FFCD 9102 phase III trial: Chemoradiation followed by surgery versus chemoradiation alone

Author

Julie, Vincent, Christophe, Mariette, Denis, Pezet, Emmanuel, Huet, Franck, Bonnetain, Olivier, Bouché, Thierry, Conroy, Bernard, Roullet, Jean-François, Seitz, Jean-Philippe, Herr, Frédéric, Di Fiore, Jean-Louis, Jouve, Laurent, Bedenne, M, Ducreux, CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Claude Huriez [Lille], CHU Lille, CHU Clermont-Ferrand, Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Normandie Université (NU), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de chirurgie digestive [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Fédération Francophone de la Cancérologie Digestive, FFCD, Hôpital Robert Debré, Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Hôpital de la Milétrie, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hôpital de la Timone [CHU - APHM] (TIMONE), Hôpital privé Sainte-Marie - Ramsay Générale de Santé, Hôpital Charles Nicolle [Rouen], Butel J, Desselle P, Brice JC, Tissot B, Votte-Lambert A, Joly J, Burtin P, Arnaud JP, Cellier P, Estermann F, Chauvet B, Maringe E, Ozanne F, Varlet F, Becouarn Y, Avril A, Rougier P, Nordlinger B, Vincendet M, Charneau J, Pillon D, Stremsdoerfer N, Pelletier M, Clavero-Fabri MC, Leduc B, Segol P, Argouach LP, Roussel A, Maurel J, Salame R, Lacourt J, Janoray P, Ruget O, Baudet-Klepping D, Dupont G, Bommelaer G, Ruszniewski P, Hammel P, Chaussade S, Dousset B, Denis B, Wagner JD, Tamby E, Petit T, Weiss AM, Barbare JC, Jouve JL, Phelip JM, Senesse P, Michiels C, Maingon P, Coudert B, Fraisse J, Queuniet A, Gasnault L, Gstach JH, Guichard B, Howaizi M, Geoffroy P, Picot C, Fournet J, Mousseau M, Stampfli C, Michel P, Doll J, Durand S, Buffet C, Triboulet JP, Denimal F, Hebbar M, Quandalle P, Mirabel X, Lledo G, Giovannini M, Souillac P, Untereiner M, Leroy-Terquem E, Lacroix H, Francois E, Lagasse JP, Breteau N, Legoux JL, Etienne JC, Delattre JF, Lubrano D, Levy-Chazal N, Palot JP, Nasca S, Demange L, Nguyen TD, Seng S, Michel P, Teniere P, Thevenet P, Le Brise H, Fleury J, Kammerer J, Cosme H, Novello P, Avignon JP, Berton C, Legueul, Parisot P, Aunis G, Vetter D, Platini C, Cals L, Rouhier D, Robin B, Champetier T, Cartalat A, Marchal C, Guillemin F, Flamenbaum M, Cassan D, Ducreux M., Hôpital Claude Huriez, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU - HÔTEL-DIEU Clermont-Ferrand, Service de chirurgie digestive [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims ( CHU Reims ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), Institut de Cancérologie de Lorraine - Alexis Vautrin ( ICL ), CHU de Poitiers, and Hôpital de la Timone [CHU - APHM] ( TIMONE )

Subjects
Male, Cancer Research, Time Factors, Esophageal Neoplasms, Kaplan-Meier Estimate, MESH: Esophagectomy, law.invention, MESH: Proportional Hazards Models, MESH : Adenocarcinoma, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, MESH : Esophagectomy, MESH: Risk Factors, MESH : Neoplasm Staging, MESH : Female, MESH : Carcinoma, Squamous Cell, MESH: Treatment Outcome, MESH: Chemoradiotherapy, Randomised controlled trial, education.field_of_study, Hazard ratio, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Carcinoma, Squamous Cell, Chemoradiotherapy, MESH : Chemoradiotherapy, MESH: Neoplasm Staging, MESH : Risk Factors, Neoadjuvant Therapy, 3. Good health, Oesophageal neoplasms, Treatment Outcome, Oncology, Chemoradiation, 030220 oncology & carcinogenesis, MESH: Esophageal Neoplasms, Carcinoma, Squamous Cell, 030211 gastroenterology & hepatology, Female, Esophageal Squamous Cell Carcinoma, France, MESH : Time Factors, medicine.medical_specialty, MESH: Radiotherapy, Adjuvant, MESH : Male, Population, MESH: Neoadjuvant Therapy, Locally advanced, MESH : Treatment Outcome, Adenocarcinoma, MESH : Radiotherapy, Adjuvant, MESH : Kaplan-Meier Estimate, 03 medical and health sciences, Early surgery, medicine, Humans, Basal cell, Salvage surgery, education, MESH : France, Contraindication, MESH: Kaplan-Meier Estimate, Neoplasm Staging, Proportional Hazards Models, MESH: Humans, business.industry, MESH : Humans, MESH: Adenocarcinoma, MESH: Time Factors, Cancer, medicine.disease, MESH : Proportional Hazards Models, MESH: Male, Surgery, Esophagectomy, MESH: France, Radiotherapy, Adjuvant, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH : Esophageal Neoplasms, business, MESH : Neoadjuvant Therapy, MESH: Female
Abstract

International audience; BACKGROUND:Two randomised trials concerning thoracic oesophageal cancer concluded that for squamous cell carcinoma, chemoradiation alone leads to the same overall survival (OS) as chemoradiation followed by surgery. One of these trials, FFCD 9102, randomised only fit, compliant and operable responders to induction chemoradiation between continuation of chemoradiation and surgery. In the present analysis, the outcome in the patients not eligible for randomisation was calculated to determine if attempt of surgery should be recommended.METHODS:Eligible patients had operable T3-N0/N1-M0 thoracic oesophageal cancer. After initial chemoradiation, patients with no clinical response, or with contraindication to follow any attributed treatment, were not randomised. OS was studied first in the whole population of not randomised patients, and then specifically in clinical non-responders. The impact of surgery on OS was studied in these two populations.FINDINGS:Of the 451 registered patients in the trial, 192 were not randomised. Among them, 111 were clinical non-responders. Median OS was significantly shorter for non-randomised patients (11.5 months) than for randomised patients (18.9 months; p=0.0024). However, for the 112 non-randomised patients who underwent surgery, median OS was not different from that in randomised patients: 17.3 versus 18.9 months (p=0.58). Concerning clinical non-responders, median OS was longer for those who underwent surgery compared to non-operated patients: 17.0 versus 5.5 months (hazard ratio (HR)=0.39 [0.25-0.61]; p

Published
2015

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