title: Retrospective comparison of chemoradiotherapy followed by adjuvant chemotherapy, with or without prior gliadel implantation (carmustine) after initial surgery in patients with newly diagnosed high-grade gliomas.
abstract: OBJECTIVE
  Retrospective study of patients treated for high-grade glioma, with or without biodegradable carmustine wafers and according to the Stupp protocol.
  
  
  METHODS
  Between May 2007 and June 2008, 65 patients underwent surgery for high-grade glioma, 28 had implantation of Gliadel and 37 patients did not. Patients received radiotherapy with concomitant temozolomide followed by 5 consecutive days of temozolomide every month for 6 months.
  
  
  RESULTS
  Overall median follow-up was 17.1 months; the median relapse-free survival (RFS) was 14 months with a RFS of 54% at 12 months, and 38% at 24 months. For patient with and without Gliadel, median and 1-year RFS were 12.9 months and 52% vs. 14 months and 42%, respectively (p = 0.89). According to pathology, Gliadel did not influence RFS of patients with Grade III or glioblastoma. However, for all patients, in multivariate analysis, non-methylated methylguanine methyltransferase (MGMT) was the only unfavorable prognostic factor of RFS (p = 0.017; HR 2.8; CI [1.2-7]). Median overall survival (OS) was 20.8 months; the OS rate at 12 months was 78.5%, and at 24 months 35.4%. For patients treated with and without Gliadel, median and 1-year OS were 20.6 months and 78.6% vs. 20.8 months and 78.4%, respectively. According to pathology, Gliadel did not influence OS of patients with Grade III or glioblastoma. For all patients, in multivariate analysis, unfavorable prognosticators for OS were non-methylated MGMT (p = 0.001; HR: 6.5; CI [2-20]) and irradiation dose <60 Gy (p = 0.02; HR: 6.3; CI [2-20]). With carmustine wafers, before irradiation, median gross tumor volume plus edema was 84 mL (27-229), whereas it was 68 mL (10-362) without carmustine (p = nonsignificant). Four cases of Grade 3 thrombopenia occurred, all in the carmustine wafer group.
  
  
  CONCLUSIONS
  In patients with high-grade gliomas, adding Gliadel before performing a Stupp protocol did not improve survival.
authors.affiliation: Radiation Oncology Department, Centre de Lutte Contre le Cancer Paul Strauss, Strasbourg, France. gnoel@strasbourg.fnclcc.fr
authors.forename: Georges
authors.initials: G
authors.lastname: Noël
authors.forename: Roland
authors.initials: R
authors.lastname: Schott
authors.forename: Sébastien
authors.initials: S
authors.lastname: Froelich
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Gaub
authors.forename: Patrick
authors.initials: P
authors.lastname: Boyer
authors.forename: David
authors.initials: D
authors.lastname: Fischer-Lokou
authors.forename: Patrick
authors.initials: P
authors.lastname: Dufour
authors.forename: Pierre
authors.initials: P
authors.lastname: Kehrli
authors.forename: Daniel
authors.initials: D
authors.lastname: Maitrot
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001254:Astrocytoma / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D001932:Brain Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D002330:Carmustine / Q000008:administration & dosage* / Q000009:adverse effects; D059248:Chemoradiotherapy / Q000379:methods*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D015254:DNA Modification Methylases / Q000378:metabolism; D045643:DNA Repair Enzymes / Q000378:metabolism; D003606:Dacarbazine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005909:Glioblastoma / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000378:metabolism; D012189:Retrospective Studies; D016019:Survival Analysis; D000077204:Temozolomide; D013921:Thrombocytopenia / Q000209:etiology; D047368:Tumor Burden; D025521:Tumor Suppressor Proteins / Q000378:metabolism; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D009363:Neoplasm Proteins; D025521:Tumor Suppressor Proteins; D003606:Dacarbazine; D015254:DNA Modification Methylases; C515491:MGMT protein, human; D045643:DNA Repair Enzymes; D002330:Carmustine; D000077204:Temozolomide