Mohamed S Zaghloul1, Eman Eldebawy2, Soha Ahmed2, Amr G Mousa2, Amr Amin2, Amal Refaat3, Iman Zaky3, Nada Elkhateeb4, Mohamed Sabry4. 1. Radiation Oncology Department, Children's Cancer Hospital, Egypt (CCHE) and National Cancer Institute, Cairo University, Egypt. Electronic address: mszagh@yahoo.com. 2. Radiation Oncology Department, Children's Cancer Hospital, Egypt (CCHE) and National Cancer Institute, Cairo University, Egypt. 3. Radiology Department, Children's Cancer Hospital, Egypt (CCHE) and National Cancer Institute, Cairo University, Egypt. 4. Research Department, Children's Cancer Hospital, Egypt.
Abstract
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-onenewly diagnosed DIPG children were randomized into hypofractionated (HF) (39Gy/13 fractions in 2.6weeks) and conventional (CF) arm (54Gy/30 fractions in 6weeks). RESULTS: The median and one-year overall survival (OS) was 7.8months 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 6.6months 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.
RCT Entities:
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 DIPGchildren were randomized into hypofractionated (HF) (39Gy/13 fractions in 2.6weeks) and conventional (CF) arm (54Gy/30 fractions in 6weeks). RESULTS: The median and one-year overall survival (OS) was 7.8months 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 6.6months 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.
Authors: Christopher L Tinkle; Brent A Orr; John T Lucas; Paul Klimo; Zoltan Patay; Suzanne J Baker; Alberto Broniscer; Ibrahim Qaddoumi Journal: Pediatr Blood Cancer Date: 2017-01-13 Impact factor: 3.167
Authors: Christopher L Tinkle; Kristen Campbell; Yuanyuan Han; Yimei Li; Brandon Bianski; Alberto Broniscer; Raja B Khan; Thomas E Merchant Journal: J Neurooncol Date: 2020-02-03 Impact factor: 4.130