The effects of the NICE Technology Appraisal 121 (gliadel and temozolomide) on survival in high-grade glioma

Br J Neurosurg. 2012 Dec;26(6):818-22. doi: 10.3109/02688697.2012.697221. Epub 2012 Jun 21.

Abstract

Objective: The prognosis of high-grade glioma (HGG) is poor with a median survival of about 1 year for glioblastoma. In 2007, NICE published a technology appraisal (TA121) recommending the use of carmustine wafers (Gliadel) and systemic therapy with temozolomide for selected patients with HGG. Outcomes for HGG surgery in the United Kingdom with these combined treatments have not been published.

Design: Retrospective audit of consecutive patients in a single unit with carmustine wafer implantation.

Subjects: Fifty-nine patients had carmustine wafers implanted at primary surgery, between October 2005 and October 2010 at Wessex Neurological Centre, Southampton, UK.

Methods: Patients were given chemotherapeutic treatments strictly according to NICE TA121. Survival was calculated using Kaplan-Meier method.

Results: Fifty-five patients had WHO grade IV tumours and four had grade III. Median age was 61 years. At follow-up, 39 patients had died. Median survival was 15.3 months. Eight patients (13.5%) experienced post-operative complications (including five infections) for which four had the carmustine wafers removed. Forty-seven (80%) patients were treated with radical radiotherapy (55-60 Gy) and six (10%) patients received palliative radiotherapy (30 Gy). Thirty-seven patients (63%) received concomitant temozolomide chemotherapy. In the subset of 37 patients receiving multimodal treatment with radical radiotherapy and concomitant temozolomide, median survival was 15.8 months compared with 7.4 months in those not receiving multimodal treatment.

Discussion: Carmustine wafers for primary HGG surgery in accordance with the NICE TA121 were associated with a median survival of 15.3 months; this is improved compared with previously reported randomised trials. Multimodal treatment with carmustine wafers, radical radiotherapy and concomitant temozolomide was associated with improved survival. Increased incidence of infections was observed in cases receiving carmustine wafers.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Alkylating / administration & dosage*
  • Antineoplastic Agents, Alkylating / adverse effects
  • Carmustine / administration & dosage*
  • Carmustine / adverse effects
  • Combined Modality Therapy
  • Dacarbazine / administration & dosage
  • Dacarbazine / adverse effects
  • Dacarbazine / analogs & derivatives*
  • Decanoic Acids / administration & dosage*
  • Decanoic Acids / adverse effects
  • Delayed-Action Preparations
  • Drug Therapy, Combination
  • Female
  • Glioblastoma* / drug therapy
  • Glioblastoma* / mortality
  • Glioblastoma* / surgery
  • Humans
  • Male
  • Middle Aged
  • Polyesters / administration & dosage*
  • Polyesters / adverse effects
  • Temozolomide
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Alkylating
  • Decanoic Acids
  • Delayed-Action Preparations
  • Polyesters
  • carmustine, poliferprosan 20 drug combination
  • Dacarbazine
  • Carmustine
  • Temozolomide