Hypofractionated conformal radiotherapy for pediatric diffuse intrinsic pontine glioma (DIPG): A randomized controlled trial

Background: The pediatric diffuse intrinsic pontine glioma (DIPG) outcome remains dismal despite multiple therapeutic attempts. Purpose: To compare the results of treatment of pediatric diffuse intrinsic pontine glioma (DIPG) using hypofractionated versus conventional radiotherapy. Patients and methods: Seventy-one newly diagnosed DIPG children were randomized into hypofractionated (HF) (39 Gy/13 fractions in 2.6 weeks) and conventional (CF) arm (54 Gy/30 fractions in 6 weeks). Results: The median and one-year overall survival (OS) was 7.8 months and 36.4 +/- 8.2% for the hypofractionated arm, and 9.5 and 26.2 +/- 7.4% for the conventional arm respectively. The 18-month OS difference was 2.2%. The OS hazard ratio (HR) was 1.14 (95% CI: 0.70-1.89) (p = 0.59). The hypofractionated arm had a median and one-year progression-free survival (PFS) of 6.6 months and 22.5 +/- 7.1%, compared to 7.3 and 17.9 +/- 7.1% for the conventional arm. The PFS HR was 1.10(95% CI: 0.67-1.90) (p = 0.71). The 18-month PFS difference was 1.1%. These differences exceed the non-inferiority margin. The immediate and delayed side effects were not different in the 2 arms. Conclusions: Hypofractionated radiotherapy offers lesser burden on the patients, their families and the treating departments, with nearly comparable results to conventional fractionation, though not fulfilling the non-inferiority assumption. 2014 Elsevier Ireland Ltd. All rights reserved.