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.

中文翻译：

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替莫唑胺在弥漫性桥脑胶质瘤中的超分割放疗：一项随机对照试验。

简介弥漫性桥脑神经胶质瘤（DIPG）是脑干神经胶质瘤的最常见形式。进行本研究是为了评估替莫唑胺在3周内完成次分割放疗是否可以改善DIPG的生存率。材料与方法本研究为II期开放标签随机试验。该研究包括新诊断的DIPG患者。A组患者在6​​周内接受了30个分数的60 Gy常规分次放疗，而B组患者在2.6周内接受了13个组分的39 Gy的低等放疗，并从第1天开始同时进行Temozolomide（TMZ）75 mg / m2至第17天，接着进行TMZ佐剂六个周期。进行了生存分析，并修改了治疗分析意图。结果共有35例患者被随机分组​​。33名患者是可评估的。常规组中93％（n = 14）的患者完成了治疗，而实验组中只有17％（n = 3）的儿童可以完成计划的治疗过程。常规组中位总生存期（OS）为11个月（95％CI-7.5至14.5个月），实验组中位数为12个月（95％CI-10.5至13.5个月）（p = 0.208）。实验组中有28％（n = 5）患者出现3或4级血液学毒性。结论上述研究表明，同时加替莫唑胺辅助治疗的次分割放疗不能改善OS，并且具有更高的血液学毒性。常规放射疗法仍然是护理的标准。常规组中位总生存期（OS）为11个月（95％CI-7.5至14.5个月），实验组中位数为12个月（95％CI-10.5至13.5个月）（p = 0.208）。实验组中有28％（n = 5）患者出现3或4级血液学毒性。结论上述研究表明，同时加替莫唑胺辅助治疗的次分割放疗不能改善OS，并且具有更高的血液学毒性。常规放射疗法仍然是护理的标准。常规组中位总生存期（OS）为11个月（95％CI-7.5至14.5个月），实验组中位数为12个月（95％CI-10.5至13.5个月）（p = 0.208）。实验组中有28％（n = 5）患者出现3或4级血液学毒性。结论上述研究表明，同时加替莫唑胺辅助治疗的次分割放疗不能改善OS，并且具有更高的血液学毒性。常规放射疗法仍然是护理的标准。结论上述研究表明，同时加替莫唑胺辅助治疗的次分割放疗不能改善OS，并且具有更高的血液学毒性。常规放射疗法仍然是护理的标准。结论上述研究表明，同时加替莫唑胺辅助治疗的次分割放疗不能改善OS，并且具有更高的血液学毒性。常规放射疗法仍然是护理的标准。