| Autor: |
Antonio Omuro, Alba A Brandes, Antoine F Carpentier, Ahmed Idbaih, David A Reardon, Timothy Cloughesy, Ashley Sumrall, Joachim Baehring, Martin van den Bent, Oliver Bähr, Giuseppe Lombardi, Paul Mulholland, Ghazaleh Tabatabai, Ulrik Lassen, Juan Manuel Sepulveda, Mustafa Khasraw, Elodie Vauleon, Yoshihiro Muragaki, Anna Maria Di Giacomo, Nicholas Butowski, Patrick Roth, Xiaozhong Qian, Alex Z Fu, Yanfang Liu, Von Potter, Alexandros-Georgios Chalamandaris, Kay Tatsuoka, Michael Lim, Michael Weller |
| Přispěvatelé: |
Neurology |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Neuro-Oncology, 25(1), 123-134. Oxford University Press |
| ISSN: |
1522-8517 |
| DOI: |
10.1093/neuonc/noac099 |
| Popis: |
Background Addition of temozolomide (TMZ) to radiotherapy (RT) improves overall survival (OS) in patients with glioblastoma (GBM), but previous studies suggest that patients with tumors harboring an unmethylated MGMT promoter derive minimal benefit. The aim of this open-label, phase III CheckMate 498 study was to evaluate the efficacy of nivolumab (NIVO) + RT compared with TMZ + RT in newly diagnosed GBM with unmethylated MGMT promoter. Methods Patients were randomized 1:1 to standard RT (60 Gy) + NIVO (240 mg every 2 weeks for eight cycles, then 480 mg every 4 weeks) or RT + TMZ (75 mg/m2 daily during RT and 150–200 mg/m2/day 5/28 days during maintenance). The primary endpoint was OS. Results A total of 560 patients were randomized, 280 to each arm. Median OS (mOS) was 13.4 months (95% CI, 12.6 to 14.3) with NIVO + RT and 14.9 months (95% CI, 13.3 to 16.1) with TMZ + RT (hazard ratio [HR], 1.31; 95% CI, 1.09 to 1.58; P = .0037). Median progression-free survival was 6.0 months (95% CI, 5.7 to 6.2) with NIVO + RT and 6.2 months (95% CI, 5.9 to 6.7) with TMZ + RT (HR, 1.38; 95% CI, 1.15 to 1.65). Response rates were 7.8% (9/116) with NIVO + RT and 7.2% (8/111) with TMZ + RT; grade 3/4 treatment-related adverse event (TRAE) rates were 21.9% and 25.1%, and any-grade serious TRAE rates were 17.3% and 7.6%, respectively. Conclusions The study did not meet the primary endpoint of improved OS; TMZ + RT demonstrated a longer mOS than NIVO + RT. No new safety signals were detected with NIVO in this study. The difference between the study treatment arms is consistent with the use of TMZ + RT as the standard of care for GBM. ClinicalTrials.gov NCT02617589 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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