Health-related quality of life and neurocognitive functioning with lomustine–temozolomide vs temozolomide in patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09): A randomised, multicentre, open-label, phase 3 trial
The Lancet Oncology Sep 11, 2019
Weller J, Tzaridis T, Mack F, et al. - Given that significantly longer overall survival was reported with combined lomustine–temozolomide therapy vs standard temozolomide in patients with glioblastoma with methylated MGMT promoter in the CeTeG/NOA-09 trial, researchers report how lomustine–temozolomide therapy influences health-related quality of life (HRQOL) and neurocognitive function. Enrollment of newly diagnosed, chemoradiotherapy-naive patients with MGMT-methylated glioblastoma, aged 18–70 years, with a Karnofsky performance score of 70% or higher, in 17 university hospitals in Germany was done in this randomised, multicentre, open-label, phase 3 trial. Standard radiotherapy (60 Gy) was administered to the patients and random allocation (1:1) of patients to receive either six 6-week courses of oral combined lomustine (100 mg/m2 on day 1) plus temozolomide (100–200 mg/m2 on days 2–6) or standard oral temozolomide (75 mg/m2 daily during radiotherapy plus six 4-week courses of temozolomide [150–200 mg/m2] on days 1–5, every 4 weeks) was done. With lomustine–temozolomide vs temozolomide alone, a survival benefit as well as no systematic and clinically relevant changes in HRQOL and neurocognitive function was observed and therefore this treatment regimen was shown to offer a long-term net clinical benefit in patients with newly diagnosed glioblastoma with methylation of the MGMT promoter. Based on the findings, the use of lomustine–temozolomide to treat these patients was supported.
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