title: Implanted carmustine wafers followed by concomitant radiochemotherapy to treat newly diagnosed malignant gliomas: prospective, observational, multicenter study on 92 cases.
abstract: OBJECTIVE
  Study the feasibility and effectiveness of a treatment associated surgery, intraoperative chemotherapy (carmustine wafers), and concomitant radiochemotherapy (temozolomide) for the management of newly diagnosed, high-grade gliomas.
  
  
  METHODS
  Prospective multicenter study conducted in 17 French centers with a total of 92 patients with newly diagnosed malignant glioma treated by surgery, implanted Carmustine wafers (Gliadel(®)) followed by concomitant radiochemotherapy by temozolomide (Temodar(®)). Clinical, imaging, and survival data were collected to study toxicity-induced adverse events and efficacy.
  
  
  RESULTS
  A total of 20.6 % presented with adverse events during surgery, potentially attributable to carmustine, including 5 severe infections. Afterwards, 37.2 % of patients showed adverse events during radiochemotherapy and 40 % during adjuvant chemotherapy by temozolomide. We report a 10.5-month, median, progression-free survival and an 18.8-month median overall survival. No significant statistical difference was observed according to age, Karnofsky Performance Scale, or grade of the tumor. A prognostic difference at the limit of the significance threshold was observed according to the extent of the resection.
  
  
  CONCLUSIONS
  Multimodal treatment associating implanted carmustine chemotherapy and concomitant radiochemotherapy with temozolomide seems to yield better survival rates than those usually described when carmustine or temozolomide are used alone independently from one another. These interesting results were obtained without increased adverse events and would need to be validated during a phase 3 study.
authors.affiliation: Department of Neurosurgery, Hôpital Maison Blanche, Reims University Hospital, Reims, France. jduntze@chu-reims.fr
authors.forename: Julien
authors.initials: J
authors.lastname: Duntze
authors.forename: Claude-Fabien
authors.initials: CF
authors.lastname: Litré
authors.forename: Christophe
authors.initials: C
authors.lastname: Eap
authors.forename: Etienne
authors.initials: E
authors.lastname: Théret
authors.forename: Adeline
authors.initials: A
authors.lastname: Debreuve
authors.forename: Nicolas
authors.initials: N
authors.lastname: Jovenin
authors.forename: Emmanuèle
authors.initials: E
authors.lastname: Lechapt-Zalcman
authors.forename: Philippe
authors.initials: P
authors.lastname: Metellus
authors.forename: Philippe
authors.initials: P
authors.lastname: Colin
authors.forename: Jean-Sébastien
authors.initials: JS
authors.lastname: Guillamo
authors.forename: Evelyne
authors.initials: E
authors.lastname: Emery
authors.forename: Philippe
authors.initials: P
authors.lastname: Menei
authors.forename: Pascal
authors.initials: P
authors.lastname: Rousseaux
authors.forename: Philippe
authors.initials: P
authors.lastname: Peruzzi
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage* / Q000009:adverse effects*; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004343:Drug Implants; D005240:Feasibility Studies; D005260:Female; D005910:Glioma / Q000601:surgery / Q000628:therapy*; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D015173:Supratentorial Neoplasms / Q000601:surgery / Q000628:therapy*; D016019:Survival Analysis; D015996:Survival Rate; D000077204:Temozolomide
chemical_list: D004343:Drug Implants; D003606:Dacarbazine; D002330:Carmustine; D000077204:Temozolomide