TEMOZOLOMIDE FOR HIGH GRADE GLIOMA (DIFFUSE)
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES : to develop a technical scientific advice for the use of concomitant temozolomide and adjuvant to radiotherapy for the treatment of diffuse gliomas when compared to the isolated radiotherapy or PCV (procarbazine, lomustine and vincristine) adjuvant regimen radiotherapy, and estimate drug costs for treatment. METHODS: A structured search was performed on the DARE, Cochrane Library, MEDLINE, EMBASE and LILACS databases. The selection of the studies was performed by two independent reviewers (Senna and Costa), and the divergences resolved by consensus. A critical review of the included studies was done using AMSTAR-2. Evaluation of the body's certainty of the evidence obtained by GRADE. The costs of the drug were estimated from the prices available at the Health Price Bank. RESULTS : 231 titles were retrieved, resulting in 5 systematic reviews. The systematic review of greater methodological rigor was selected (Hart et al, 2013), and the results of the meta-analysis performed by the authors were used. Increased overall survival favored temozolomide compared to isolated radiotherapy (HR 0.60, 95% CI 0.46-0.79), p = 0.0003. Progression-free survival, favorable results for temozolomide (HR 0.63, 95% CI 0.43-0.92). Degree of confidence assessed as moderate by GRADE for these outcomes. No studies with PCV regimen for initial diagnosis of diffuse glioma were found. Increase the risk mainly for hematologic adverse events: OR 8.09, 95% (CI 4.69-13.97), with a high degree of confidence in GRADE. Cost of temozolamide at the minimum dose was US $ 6,465.30; and at the maximum dose was US $ 12,149.70. CONCLUSIONS : Considering that temozolomide showed a low magnitude but important absolute effect in relation to the clinical condition of the patient (2 months in overall survival and 1.9 months for progression-free survival), and based on a moderate degree of certainty it was concluded that the recommendation should be weak in favor of technology.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PND88
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Neurological Disorders