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Concurrent and Adjuvant Temozolomide for Newly Diagnosed Grade III Gliomas Without 1p/19q Co-deletion: A Randomized, Open-Label, Phase 2 Study (KNOG-1101 Study)

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Author(s)
Kihwan HwangTae Min KimChul-Kee ParkJong Hee ChangTae-Young JungJin Hee KimDo-Hyun NamSe-Hyuk KimHeon YooYong-Kil HongEun-Young KimDong-Eun LeeJungnam JooYu Jung KimGheeyoung ChoeByung Se ChoiSeok-Gu KangJeong Hoon KimChae-Yong Kim
Keimyung Author(s)
Kim, Jin Hee
Department
Dept. of Radiation Oncology (방사선종양학)
Journal Title
Cancer Research and Treatment
Issued Date
2019
Keyword
Anaplastic glioma1p/19q co-deletionTemozolomideChemotherapyAdjuvant treatment
Abstract
Purpose:
We investigated the efficacy of temozolomide during and after radiotherapy in Korean adults with 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 for Korean grade III glioma patients. Eligible patients were aged 18 years or older and had newly diagnosed non-co-deleted anaplastic glioma with an Eastern Cooperative Oncology Group performance status of 0-2. Patients were randomized 1:1 to receive radiotherapy alone (60 Gy in 30 fractions of 2 Gy) (control group, n=44) or to receive radiotherapy with concurrent temozolomide (75 mg/m2/day) followed by adjuvant temozolomide (150-200 mg/m2/day for 5 days during 6 28-day cycles) (treatment group, n=40). The primary endpoint was 2-year progression-free survival (PFS). Seventy patients (83.3%) were available for 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. Overall survival (OS) did not reach to significant difference between the groups. In multivariable analysis, age was a significant risk factor for PFS (hazard ratio [HR], 2.08; 95% confidence interval [CI], 1.04 to 4.16). The IDH1 mutation was the only significant prognostic factor for PFS (HR, 0.28; 95% CI, 0.13 to 0.59) and OS (HR, 0.19; 95% CI, 0.07 to 0.50). Adverse events over grade 3 were seen in 16 patients (40.0%) in the treatment group and were reversible.

Conclusion:
Concurrent and adjuvant temozolomide in Korean adults with newly diagnosed non-co-deleted anaplastic gliomas showed improved 2-year PFS. The survival benefit of this regimen needs further analysis with long-term follow-up at least more than 10 years.
Keimyung Author(s)(Kor)
김진희
Publisher
School of Medicine (의과대학)
Citation
Kihwan Hwang et al. (2019). Concurrent and Adjuvant Temozolomide for Newly Diagnosed Grade III Gliomas Without 1p/19q Co-deletion: A Randomized, Open-Label, Phase 2 Study (KNOG-1101 Study). Cancer Research and Treatment. doi: 10.4143/crt.2019.421
Type
Article
ISSN
2005-9256
Source
https://www.e-crt.org/journal/view.php?doi=10.4143/crt.2019.421
DOI
10.4143/crt.2019.421
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42326
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학)
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