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)

Kihwan Hwang, 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

Research output: Contribution to journalArticle

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 end-point 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.

Original languageEnglish
Pages (from-to)505-515
Number of pages11
JournalCancer research and treatment : official journal of Korean Cancer Association
Volume52
Issue number2
DOIs
Publication statusPublished - 2020 Apr 1

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Hwang, K., Kim, T. M., Park, C. K., Chang, J. H., Jung, T. Y., Kim, J. H., Nam, D. H., Kim, S. H., Yoo, H., Hong, Y. K., Kim, E. Y., Lee, D. E., Joo, J., Kim, Y. J., Choe, G., Choi, B. S., Kang, S. G., Kim, J. H., & Kim, C. Y. (2020). 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 : official journal of Korean Cancer Association, 52(2), 505-515. https://doi.org/10.4143/crt.2019.421