title: Impact of the per-operatory application of GLIADEL wafers (BCNU, carmustine) in combination with temozolomide and radiotherapy in patients with glioblastoma multiforme: efficacy and toxicity.
abstract: OBJECTIVE
  For the last few years wafers of Gliadel have been inserted into the operation cavity in patients with glioblastoma multiforme. This is followed by concurrent radio-chemotherapy with temozolomide (TMZ) according to the Stupp protocol. Only a few studies have investigated this kind of treatment regimen and the impact in terms of survival and toxicity of the combination of Gliadel with TMZ and radiotherapy.
  
  
  METHODS
  From November 2006 to January 2010, 24 patients with a newly diagnosed glioblastoma have undergone a tumour resection which was considered to be macroscopically complete in 12 cases and with tumour residue in another 12 cases. The mean age at the moment of diagnosis was 60.25years and the median age 63. Twenty-three patients underwent subsequently concurrent radio-chemotherapy with TMZ followed by cycles of elevated doses of TMZ as an adjuvant treatment. One patient had adjuvant radiotherapy alone followed by adjuvant chemotherapy. Thirteen were able to receive 6 or more cycles of adjuvant TMZ. Seven patients had received less than 6 cycles of TMZ as an adjuvant therapy. Two patients did not receive adjuvant TMZ at all.
  
  
  RESULTS
  The median overall survival of our group was 19.2months and the median progression free survival was 12.3months. Overall survival for the macroscopically complete-resection patients was 14months, and 12.85months in subtotal-resection patients. The median OS was 14.25months for patients PS 0 - 1 at the moment of diagnosis and 12.65 for PS 2 patients. Chemotherapy with TMZ had to be stopped prematurely in 10 cases due to haematotoxicity, digestive toxicity or early relapse.
  
  
  CONCLUSIONS
  The concomitant use of surgery with implantation of BCNU wafers and radio-chemotherapy seems to be well tolerated. Despite the small number of patients treated in our group, particular attention should be paid to the potential haematological consequences of this multimodal treatment regimen.
authors.affiliation: Department of Radiotherapy, Institute of Oncology and Haematology, University Hospital Morvan, 2 Avenue Foch, Brest, France. pmiglierini@gmail.com
authors.forename: Petra
authors.initials: P
authors.lastname: Miglierini
authors.forename: Mohamed
authors.initials: M
authors.lastname: Bouchekoua
authors.forename: Benoit
authors.initials: B
authors.lastname: Rousseau
authors.forename: Phong Dam
authors.initials: PD
authors.lastname: Hieu
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Malhaire
authors.forename: Olivier
authors.initials: O
authors.lastname: Pradier
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003652:Decanoic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D011091:Polyesters / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003652:Decanoic Acids; D011091:Polyesters; C574855:carmustine, poliferprosan 20 drug combination; D003606:Dacarbazine; D002330:Carmustine; D000077204:Temozolomide