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Hypofractionated radiotherapy with temozolomide in diffuse intrinsic pontine gliomas: a randomized controlled trial

  • Yousra Izzuddeen
  • Subhash GuptaEmail author
  • K. P. Haresh
  • Dayanand Sharma
  • Prashanth Giridhar
  • Gour Kishore Rath
Clinical Study

Abstract

Introduction

Diffuse intrinsic pontine glioma (DIPG) is the most common form of brainstem glioma. The present study was performed to assess if hypofractionated radiotherapy completed in < 3 weeks with temozolomide improves survival in DIPG.

Material and methods

The present study is a phase II open label randomized trial. The study included newly diagnosed patients with DIPG. Patients in arm A received conventional fractionated RT of 60 Gy in 30 fractions over 6 weeks while patients in arm B received hypo-fractionated radiotherapy of 39 Gy in 13 fractions over 2.6 weeks along with concurrent Temozolomide (TMZ) 75 mg/m2 from day 1 to day 17 followed by adjuvant TMZ for six cycles. The survival analysis was performed with modified intention to treat analysis.

Results

A total of 35 patients were randomized. 33 patients were evaluable. 93% (n = 14) of patients in the conventional arm completed treatment while only 17% (n = 3) of the children could complete planned course of treatment in the experimental arm. The median overall survival (OS) was 11 months (95% CI − 7.5 to 14.5 months) in the conventional arm and 12 months (95% CI − 10.5 to 13.5 months) in the experimental arm (p = 0.208). 28% (n = 5) patients in the experimental arm developed grade 3 or 4 hematological toxicity.

Conclusion

The above study shows that hypofractionated radiotherapy with concurrent and adjuvant temozolomide does not improve OS and has higher hematological toxicity. Conventional radiotherapy remains the standard of care.

Keywords

Diffuse intrinsic pontine glioma Hypofractionation Temozolomide 

Notes

Compliance with ethical standards

Conflict of interest

No author has any potential conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committee.

Informed consent

It was obtained from all individual participants included in the study.

Supplementary material

11060_2019_3340_MOESM1_ESM.docx (11 kb)
Supplementary file1 (DOCX 11 kb)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Radiation OncologyAll India Institute of Medical SciencesNew DelhiIndia
  2. 2.Department of Radiation Oncology, National Cancer InstituteAll India Institute of Medical SciencesBadsaIndia

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