Phase 2 Study of a Temozolomide-Based Chemoradiation Therapy Regimen for High-Risk, Low-Grade Gliomas: Long-Term Results of Radiation Therapy Oncology Group 0424

Barbara J. Fisher, Stephanie L. Pugh, David R. Macdonald, Arnab Chakravatri, Glenn J. Lesser, Sherry Fox, C. Leland Rogers, Maria Werner-Wasik, Thomas Doyle, Jean Paul Bahary, John B. Fiveash, Joseph A. Bovi, Steven P. Howard, Hsiang Hsuan Michael Yu, David D'Souza, Nadia N. Laack, Igor J. Barani, Young Kwok, Daniel R. Wahl, Jon F. StrasserMinhee Won, Minesh P. Mehta

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Purpose: To report the long-term outcomes of the RTOG 0424 study of a high-risk, low-grade glioma population treated with concurrent and adjuvant temozolomide (TMZ) and radiation therapy (RT). Methods and Materials: For this single-arm, phase 2 study, patients with low-grade gliomas with ≥3 risk factors (age ≥40 years, astrocytoma, bihemispheric tumor, size ≥6 cm, or preoperative neurologic function status >1) received RT (54 Gy in 30 fractions) with TMZ and up to 12 cycles of post-RT TMZ. The initial primary endpoint P was overall survival (OS) at 3 years after registration. Secondary endpoints included progression-free survival (PFS) and the association of survival outcomes with methylation status. The initial 3-year report of this study was published in 2015. Results: The study accrued 136 patients, of whom 129 were analyzable. The median follow-up for surviving patients was 9.0 years. The 3-year OS was 73.5% (95% confidence interval, 65.8%-81.1%), numerically superior to the 3-year OS historical control of 54% (P <.001). The median survival time was 8.2 years (95% confidence interval, 5.6-9.1). Five- and 10-year OS rates were 60.9% and 34.6%, respectively, and 5- and 10-year PFS rates were 46.8% and 25.5%, respectively. Conclusions: The long-term results confirmed the findings from the initial report for efficacy, suggesting OS and PFS outcomes with the RT-TMZ regimen exceeded historical control groups treated with radiation alone. Toxicity was acceptable.

Original languageEnglish (US)
Pages (from-to)720-725
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Volume107
Issue number4
DOIs
StatePublished - Jul 15 2020

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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