Cancer Res Treat.  2020 Apr;52(2):505-515. 10.4143/crt.2019.421.

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

Affiliations
  • 1Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
  • 2Departments of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
  • 3Departments of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
  • 4Department of Neurosurgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 5Department of Neurosurgery, Chonnam National University Hwasun Hospital, Hwasun, Korea
  • 6Department of Radiation Oncology, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea
  • 7Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 8Department of Neurosurgery, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea
  • 9Department of Neuro-Oncology Clinic, Center for Specific Organs Cancer, National Cancer Center Hospital, National Cancer Center, Goyang, Korea
  • 10Department of Neurosurgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 11Department of Neurosurgery, Inha University Hospital, Inha University School of Medicine, Incheon, Korea
  • 12Division of Cancer Epidemiology and Management, Research Institute, National Cancer Center, Goyang, Korea
  • 13Departments of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
  • 14Departments of Pathology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
  • 15Departments of Radiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
  • 16Department of Neurological Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

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 six 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 IDH1mutation 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 nonco- 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.

Keyword

Anaplastic glioma; 1p/19q co-deletion; Temozolomide; Chemotherapy; Adjuvant treatment
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