Adjuvant Temozolomide Chemotherapy With or Without Interferon Alfa Among Patients With Newly Diagnosed High-grade Gliomas

作者：Chengcheng Guo, Qunying Yang, Pengfei Xu, Meiling Deng, Taipeng Jiang, Linbo Cai, Jibin Li, Ke Sai, Shaoyan Xi, Hui Ouyang, Mingfa Liu, Xianming Li, Zihuang Li, Xiangrong Ni, Xi Cao, Cong Li, Shaoxiong Wu, Xiaojing Du, Jun Su, Xiaoying Xue, Yiming Wang, Gang Li, Zhiyong Qin, Hui Yang, Tao Zhou, Jinquan Liu, Xuefeng Hu, Jian Wang, Xiaobing Jiang, Fuhua Lin, Xiangheng Zhang, Chao Ke, Xiaofei Lv, Yanchun Lv, Wanming Hu, Jing Zeng, Zhenghe Chen, Zhenghe Chen, Sheng Zhong, Hairong Wang, Yinsheng Chen, Ji Zhang, De‐Pei Li, Yonggao Mou, Zhongping Chen, Zhongping Chen · 发表于：JAMA Network Open · 年份：2023 · DOI：10.1001/jamanetworkopen.2022.53285 · 被引用次数：33 · 研究领域：Glioma Diagnosis and Treatment、Brain Metastases and Treatment、Meningioma and schwannoma management

Importance: High-grade gliomas (HGGs) constitute the most common and aggressive primary brain tumor, with 5-year survival rates of 30.9% for grade 3 gliomas and 6.6% for grade 4 gliomas. The add-on efficacy of interferon alfa is unclear for the treatment of HGG. Objectives: To compare the therapeutic efficacy and toxic effects of the combination of temozolomide and interferon alfa and temozolomide alone in patients with newly diagnosed HGG. Design, Setting, and Participants: This multicenter, randomized, phase 3 clinical trial enrolled 199 patients with newly diagnosed HGG from May 1, 2012, to March 30, 2016, at 15 Chinese medical centers. Follow-up was completed July 31, 2021, and data were analyzed from September 13 to November 24, 2021. Eligible patients were aged 18 to 75 years with newly diagnosed and histologically confirmed HGG and had received no prior chemotherapy, radiotherapy, or immunotherapy for their HGG. Interventions: All patients received standard radiotherapy concurrent with temozolomide. After a 4-week break, patients in the temozolomide with interferon alfa group received standard temozolomide combined with interferon alfa every 28 days. Patients in the temozolomide group received standard temozolomide. Main Outcomes and Measures: The primary end point was 2-year overall survival (OS). Secondary end points were 2-year progression-free survival (PFS) and treatment tolerability. Results: A total of 199 patients with HGG were enrolled, with a median follow-up...