A Phase 1/2 Trial of Reirradiation for Diffuse Intrinsic Pontine Glioma

Mark J. Amsbaugh, Anita Mahajan, Peter F. Thall, Mary Frances McAleer, Arnold C. Paulino, David Grosshans, Soumen Khatua, Leena Ketonen, Hiral Fontanilla, Susan L. McGovern

Research output: Contribution to journalArticlepeer-review

33 Scopus citations

Abstract

Purpose: To identify an optimal dose for reirradiation (reRT) of diffuse intrinsic pontine glioma. Methods and Materials: ReRT dose levels were selected using an adaptive utility–based dose-finding method. The coprimary endpoints were toxicity (mild, moderate, high, or severe) and efficacy, evaluated 1 month after reRT. Efficacy was defined as improvements in imaging, clinical status, and quality of life. Secondary endpoints were progression-free and overall survival. Utility of each dose level was calculated based on a combined toxicity/efficacy score, ranging from 0 for (severe toxicity, no efficacy) to 100 for (mild toxicity, all 3 efficacy improvements). Results: Twelve patients completed reRT at 3 dose levels: 24 Gy in 12 fractions (6 patients), 26.4 Gy in 12 fractions (4 patients), and 30.8 Gy in 14 fractions (2 patients). One patient treated at dose level 3 developed a grade 3 acute toxicity. Five of the 6 patients receiving 24 Gy demonstrated improvement in 2 of 3 efficacy domains, and the sixth demonstrated improvement in all efficacy domains. Of 4 patients receiving 26.4 Gy, 1 demonstrated no improvement, and 1 patient each demonstrated improvement in 1, 2, and 3 efficacy domains. Of 2 patients receiving 30.8 Gy, 1 demonstrated improvement in 3 efficacy domains, and 1 did not complete the quality of life and was not assessed. Mean utilities were 88 for dose level 1, 76 for dose level 2, and 25 for dose level 3. For all patients, the median overall survival was 19.5 months from initial diagnosis (95% confidence interval, 15.6-21.1 months), and the median progression-free survival was 4.5 months from the start of reRT (95% confidence interval, 2.7-6.2 months). Conclusions: ReRT can safely be delivered for progressive diffuse intrinsic pontine glioma. Clinical improvement was seen in almost all patients. Utility analysis suggests that a regimen of 24 Gy in 12 fractions is preferred.

Original languageEnglish (US)
Pages (from-to)144-148
Number of pages5
JournalInternational Journal of Radiation Oncology Biology Physics
Volume104
Issue number1
DOIs
StatePublished - May 1 2019

ASJC Scopus subject areas

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

MD Anderson CCSG core facilities

  • Biostatistics Resource Group

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