Radiotherapy with adjuvant temozolomide chemotherapy in newly diagnosed low-grade glioma patients:preliminary results of a multicenter,open-label,randomized controlled clinical trial
HE Changjia
SAI Ke
GUO Chengcheng
YANG Qunying
CAI Linbo
LAI Mingyao
WANG Xiang
WANG Liang
SHENG Xiaofang
XIA Yunfei
WU Shaoxiong
MU Yonggao
ZHANG Xiangheng
WANG Jian
KE Chao
CHEN Yinsheng
XI Shaoyan
XIE Chuanmiao
LIAO Yixiang
CHEN Zhongping
Abstract：Background As defined by the 2021 World Health Organization(WHO)fifth edition classification of central nervous system tumors,WHO grade 2 gliomas represent the most prevalent low-grade glioma subtype in young adults,often resulting in progressive neurological decline and premature mortality.Previous studies have shown that postoperative radiotherapy combined with PCV(procarbazine+lomustine+vincristine combination chemotherapy regimen)chemotherapy in adults with residual diffuse low-grade gliomas offers benefits in progression-free survival(PFS)and overall survival(OS).However,the role of temozolomide chemotherapy after radiotherapy in such patients remains unclear.This study aims to explore the hypothesis that adding TMZ chemotherapy after radiotherapy can improve the survival rate and progression-free survival of patients with residual LGG compared to radiotherapy alone.Methods Patients with residual LGG(including WHO grade 2 astrocytoma,oligodendroglioma,and oligodendroastrocytoma,according to the 2007 WHO Classification of Tumours of the Central Nervous System(4th Edition))after surgery were enrolled and randomly assigned to either the radiotherapy plus TMZ group(RC group)or the radiotherapy alone group(RT group).The total dose of radiotherapy was 54.0 Gy.Patients in the RT group were followed up after completing radiotherapy,while patients in the RC group received up to six cycles of TMZ chemotherapy starting 4 weeks after radiotherapy.Clinical characteristics were analyzed using SPSS 26.0 and R 4.2.1 to assess baseline data,generate Kaplan-Meier survival curves,and perform univariate Cox regression analysis to compare survival outcomes and risk factors between the two groups and subgroups.Results Between 2012 and 2021,248 eligible patients were recruited.By the final follow-up in December 2023,26 patients were excluded due to missing clinical data,leaving 222 patients for analysis.The median follow-up time was[57.1(range:39.0-73.0)]months.Neither group reached a median PFS or median OS.The 5-year OS for the RT group was 89%,and the 5-year PFS was 72%.In the RC group,the 5-year OS was 87%,and the 5-year PFS was 78%.There were no significant differences in overall PFS(HR:1.094[0.624-1.917],P=0.580)or OS(HR:1.267[0.586-2.738],P=0.700)between the two groups.Subgroup analysis based on age showed no significant differences in OS or PFS between the two groups for patients aged≤40 years versus those>40 years(P>0.05).Similarly,subgroup analysis by postoperative histological type also showed no significant differences in PFS or OS between the RT and RC groups(P>0.05).Conclusion In patients with residual LGG after surgery,there is no significant difference in outcomes between radiotherapy alone and radiotherapy plus TMZ chemotherapy.However,further extended follow-up and more comprehensive molecular pathological analysis are needed to assess the impact of molecular subtypes on individualized treatment and prognosis.
Keywords：Low-grade gliomaLGGPostoperative residualsRadiotherapyTemozolomideSurvival analysis
Publication Date：2025-08-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：8( 5-12 )