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Extended Dosing (12 Cycles) of Adjuvant Temozolomide in Adults with Newly Diagnosed High Grade Gliomas: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines

Last updated: February 26, 2018
Project Number: RC0967-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness of extended dosing (12 cycles) of adjuvant temozolomide in adult patients with newly diagnosed high grade gliomas?
  2. What is the cost-effectiveness of extended dosing (12 cycles) of adjuvant temozolomide in adult patients with newly diagnosed high grade gliomas?
  3. What are the evidence-based guidelines associated with the use of adjuvant temozolomide in adult patients with newly diagnosed high grade gliomas?

Key Message

Evidence from two randomized controlled trials and one non-randomized controlled trial of adult patients with newly-diagnosed gliomas suggest that compared with the conventional 6-cycle adjuvant temozolomide therapy, the 12-cycle regimen was associated with improved survival outcomes, including overall survival and progression-free survival, although the between-group difference in overall survival was not statistically significant. The use of 12-cycle adjuvant temozolomide therapy was also related to higher risks of Grade 3-4 toxicities compared with the 6-cycle regimen, especially for hematological toxicities. However, the clinical effectiveness of extended dosing of adjuvant temozolomide relative to conventional 6-cycle regimen should be interpreted with caution, due to the compromised quality and the small sample size in some of the included trials. Two evidence-based clinical practice guidelines developed in Spain recommend the use of 12-cycle adjuvant temozolomide therapy after surgery and radiotherapy, for newly-diagnosed glioblastoma in elderly patients ( 65 years) or anaplastic astrocytoma.No relevant economic evaluations were identified from the literature to examine the cost-effectiveness of 12-cycle temozolomide therapy in the population of interest.