Johan Pallud1, Etienne Audureau1, Georges Noel1, Robert Corns1, Emmanuèle Lechapt-Zalcman1, Julien Duntze1, Vladislav Pavlov1, Jacques Guyotat1, Phong Dam Hieu1, Pierre-Jean Le Reste1, Thierry Faillot1, Claude-Fabien Litre1, Nicolas Desse1, Antoine Petit1, Evelyne Emery1, Jimmy Voirin1, Johann Peltier1, François Caire1, Jean-Rodolphe Vignes1, Jean-Luc Barat1, Olivier Langlois1, Edouard Dezamis1, Eduardo Parraga1, Marc Zanello1, Edmond Nader1, Michel Lefranc1, Luc Bauchet1, Bertrand Devaux1, Philippe Menei1, Philippe Metellus1. 1. Department of Neurosurgery, Sainte-Anne Hospital, Paris, France (J.P., V.P., E.D., E.P., M.Z., B.D.); Paris Descartes University, Paris, France (J.P., V.P., E.D., E.P., M.Z., B.D.); Department of Histopathology and Animal Models, Institut Pasteur, Paris, France (J.P.); Réseau d'Etude des Gliomes (REG), France (J.P., L.B.); Public Health Department, Henri Mondor Teaching Hospital, Créteil, France (E.A.); Laboratoire d'Investigation Clinique, Université Paris Est Créteil, Créteil, France (E.A.); Radiotherapy Department, Centre de Lutte Contre le Cancer Paul Strauss, Strasbourg, France (G.N.); Radiobiology Laboratory, Federation of Translationnal Medicine de Strasbourg (FMTS), Strasbourg University, Strasbourg, France (G.N.); Department of Neurosurgery, Leeds General Infirmary, Leeds, United Kingdom (R.C.); Department of Pathology, Caen University Hospital, Caen, France (E.L.-Z.); CNRS, UMR 6232 CERVOxy Group, Caen, France (E.L.-Z.); University of Caen Basse-Normandie, UMR 6232 CERVOxy Group, Caen, France (E.L.-Z.); CEA, UMR 6232 CERVOxy Group, Caen, France (E.L.-Z.); Department of Neurosurgery, Maison Blanche Hospital, Reims University Hospital, Reims, France (J.D., C.-F.L.); Service of Neurosurgery D, Lyon Civil Hospitals, Pierre Wertheimer Neurological and Neurosurgical Hospital, Lyon, France (J.G.); Department of Neurosurgery, Faculty of Medicine, University Medical Center, University of Brest, Brest, France (P.D.H.); Department of Neurosurgery, University Hospital Pontchaillou, Rennes, France (P.-J.L.R.); Department of Neurosurgery, APHP Beaujon Hospital, Clichy, France (T.F.); Department of Neurosurgery, Sainte Anne Military Teaching Hospital, Toulon, France (N.D.); Department of Neurosurgery, University Hospital Jean Minjoz, Besançon, France (A.P.); Departement of Neurosurgery, University Hospital of Caen, University of Lower Normandy, Caen, France (E.E.); Department of Neurosurgery, Pasteur Hospital, Colmar, France (J.V.); Department of Neurosurgery, Haut
Abstract
BACKGROUND: The standard of care for newly diagnosed glioblastoma is maximal safe surgical resection, followed by chemoradiation therapy. We assessed carmustine wafer implantation efficacy and safety when used in combination with standard care. METHODS: Included were adult patients with (n = 354, implantation group) and without (n = 433, standard group) carmustine wafer implantation during first surgical resection followed by chemoradiation standard protocol. Multivariate and case-matched analyses (controlled propensity-matched cohort, 262 pairs of patients) were conducted. RESULTS: The median progression-free survival was 12.0 months (95% CI: 10.7-12.6) in the implantation group and 10.0 months (9.0-10.0) in the standard group and the median overall survival was 20.4 months (19.0-22.7) and 18.0 months (17.0-19.0), respectively. Carmustine wafer implantation was independently associated with longer progression-free survival in patients with subtotal/total surgical resection in the whole series (adjusted hazard ratio [HR], 0.76 [95% CI: 0.63-0.92], P = .005) and after propensity matching (HR, 0.74 [95% CI: 0.60-0.92], P = .008), whereas no significant difference was found for overall survival (HR, 0.95 [0.80-1.13], P = .574; HR, 1.06 [0.87-1.29], P = .561, respectively). Surgical resection at progression whether alone or combined with carmustine wafer implantation was independently associated with longer overall survival in the whole series (HR, 0.58 [0.44-0.76], P < .0001; HR, 0.54 [0.41-0.70], P < .0001, respectively) and after propensity matching (HR, 0.56 [95% CI: 0.40-0.78], P < .0001; HR, 0.46 [95% CI: 0.33-0.64], P < .0001, respectively). The higher postoperative infection rate in the implantation group did not affect survival. CONCLUSIONS: Carmustine wafer implantation during surgical resection followed by the standard chemoradiation protocol for newly diagnosed glioblastoma in adults resulted in a significant progression-free survival benefit.
BACKGROUND: The standard of care for newly diagnosed glioblastoma is maximal safe surgical resection, followed by chemoradiation therapy. We assessed carmustine wafer implantation efficacy and safety when used in combination with standard care. METHODS: Included were adult patients with (n = 354, implantation group) and without (n = 433, standard group) carmustine wafer implantation during first surgical resection followed by chemoradiation standard protocol. Multivariate and case-matched analyses (controlled propensity-matched cohort, 262 pairs of patients) were conducted. RESULTS: The median progression-free survival was 12.0 months (95% CI: 10.7-12.6) in the implantation group and 10.0 months (9.0-10.0) in the standard group and the median overall survival was 20.4 months (19.0-22.7) and 18.0 months (17.0-19.0), respectively. Carmustine wafer implantation was independently associated with longer progression-free survival in patients with subtotal/total surgical resection in the whole series (adjusted hazard ratio [HR], 0.76 [95% CI: 0.63-0.92], P = .005) and after propensity matching (HR, 0.74 [95% CI: 0.60-0.92], P = .008), whereas no significant difference was found for overall survival (HR, 0.95 [0.80-1.13], P = .574; HR, 1.06 [0.87-1.29], P = .561, respectively). Surgical resection at progression whether alone or combined with carmustine wafer implantation was independently associated with longer overall survival in the whole series (HR, 0.58 [0.44-0.76], P < .0001; HR, 0.54 [0.41-0.70], P < .0001, respectively) and after propensity matching (HR, 0.56 [95% CI: 0.40-0.78], P < .0001; HR, 0.46 [95% CI: 0.33-0.64], P < .0001, respectively). The higher postoperative infection rate in the implantation group did not affect survival. CONCLUSIONS:Carmustine wafer implantation during surgical resection followed by the standard chemoradiation protocol for newly diagnosed glioblastoma in adults resulted in a significant progression-free survival benefit.
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