Concurrent and Adjuvant Temozolomide for Newly Diagnosed Grade IIIGliomas without 1p/19q Co-deletion: A Randomized, Open-Label,Phase 2 Study (KNOG-1101 Study)
- Author:
Kihwan HWANG
1
;
Tae Min KIM
;
Chul-Kee PARK
;
Jong Hee CHANG
;
Tae-Young JUNG
;
Jin Hee KIM
;
Do-Hyun NAM
;
Se-Hyuk KIM
;
Heon YOO
;
Yong-Kil HONG
;
Eun-Young KIM
;
Dong-Eun LEE
;
Jungnam JOO
;
Yu Jung KIM
;
Gheeyoung CHOE
;
Byung Se CHOI
;
Seok-Gu KANG
;
Jeong Hoon KIM
;
Chae-Yong KIM
Author Information
- Publication Type:Original Article
- From:Cancer Research and Treatment 2020;52(2):505-515
- CountryRepublic of Korea
- Language:0
-
Abstract:
Purpose:We investigated the efficacy of temozolomide during and after radiotherapy in Korean adultswith anaplastic gliomas without 1p/19q co-deletion.
Materials and Methods:This was a randomized, open-label, phase 2 study and notably the first multicenter trial forKorean grade III glioma patients. Eligible patients were aged 18 years or older and hadnewly diagnosed non-co-deleted anaplastic glioma with an Eastern Cooperative OncologyGroup performance status of 0-2. Patients were randomized 1:1 to receive radiotherapyalone (60 Gy in 30 fractions of 2 Gy) (control group, n=44) or to receive radiotherapy withconcurrent temozolomide (75 mg/m2/day) followed by adjuvant temozolomide (150-200mg/m2/day for 5 days during six 28-day cycles) (treatment group, n=40). The primary endpointwas 2-year progression-free survival (PFS). Seventy patients (83.3%) were availablefor the analysis of the isocitrate dehydrogenase 1 gene (IDH1) mutation status.
Results:The two-year PFS was 42.2% in the treatment group and 37.2% in the control group. Overallsurvival (OS) did not reach to significant difference between the groups. In multivariableanalysis, age was a significant risk factor for PFS (hazard ratio [HR], 2.08; 95% confidenceinterval [CI], 1.04 to 4.16). The IDH1mutation was the only significant prognostic factor forPFS (HR, 0.28; 95% CI, 0.13 to 0.59) and OS (HR, 0.19; 95% CI, 0.07 to 0.50). Adverseevents over grade 3 were seen in 16 patients (40.0%) in the treatment group and werereversible.
Conclusion:Concurrent and adjuvant temozolomide in Korean adults with newly diagnosed nonco-deleted anaplastic gliomas showed improved 2-year PFS. The survival benefit of this regimenneeds further analysis with long-term follow-up at least more than 10 years.
