Pallud Johan, Audureau Etienne, Noel Georges, Corns Robert, Lechapt-Zalcman Emmanuèle, Duntze Julien, Pavlov Vladislav, Guyotat Jacques, Hieu Phong Dam, Le Reste Pierre-Jean, Faillot Thierry, Litre Claude-Fabien, Desse Nicolas, Petit Antoine, Emery Evelyne, Voirin Jimmy, Peltier Johann, Caire François, Vignes Jean-Rodolphe, Barat Jean-Luc, Langlois Olivier, Dezamis Edouard, Parraga Eduardo, Zanello Marc, Nader Edmond, Lefranc Michel, Bauchet Luc, Devaux Bertrand, Menei Philippe, Metellus Philippe
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
Neuro Oncol. 2015 Dec;17(12):1609-19. doi: 10.1093/neuonc/nov126. Epub 2015 Jul 16.
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.
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.
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.
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.
新诊断的胶质母细胞瘤的标准治疗方案是进行最大安全限度的手术切除,随后进行放化疗。我们评估了卡莫司汀晶片植入联合标准治疗的疗效和安全性。
纳入了在首次手术切除时接受(n = 354,植入组)和未接受(n = 433,标准组)卡莫司汀晶片植入、随后接受标准化放化疗方案的成年患者。进行了多变量分析和病例匹配分析(倾向评分匹配队列,262对患者)。
植入组的无进展生存期(PFS)中位数为12.0个月(95%CI:10.7 - 12.6),标准组为10.0个月(9.0 - 10.0);总生存期(OS)中位数分别为20.4个月(19.0 - 22.7)和18.0个月(17.0 - 19.0)。在整个队列中,卡莫司汀晶片植入与次全/全切除术后患者更长的无进展生存期独立相关(校正风险比[HR],0.76[95%CI:0.63 - 0.92],P = 0.005),倾向评分匹配后也是如此(HR,0.74[95%CI:0.60 - 0.92],P = 0.008),而总生存期无显著差异(HR,0.95[0.80 - 1.13],P = 0.574;HR,1.06[0.87 - 1.29],P = 0.561)。疾病进展时进行手术切除,无论单独进行还是联合卡莫司汀晶片植入,在整个队列中(HR,0.58[0.44 - 0.76],P < 0.0001;HR,0.54[0.41 - 0.70],P < 0.0001)以及倾向评分匹配后(HR,0.56[95%CI: