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Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed glioblastoma Patients？ A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial

引用

Chinese Medical Journal 2015年第20期128卷 2751-2758页

作者： Ying Mao Yu Yao Li-Wei Zhang Yi-Cheng Lu Zhong-Ping Chen Jian-Min Zhang Song-Tao Qi Chao You Ren-Zhi Wang Shu-Yuan Yang Xiang Zhang Ji-Sheng Wang Ju-Xiang Chen Qun-Ying Yang Hong Shen Zhi-Yong Li Xiang Wang Wen-Bin Ma Xue-Jun Yang Hai-Ning Zhen Liang-Fu Zhou Department of Neurosurgery Huashan Hospital Fudan University Shanghai 200040 China Department of Neurosurgery Beijing Tiantan Hospital Capital Medical University Beijing 100050 China Department of Neurosurgery Changzheng Hospital Second Military Medical University Shanghai 200003 China Sun Yat-Sen University Cancer Center Guangzhou Guangdong 510060 China Department of Neurosurgery The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang 310009 China Department of Neurosurgery Nanfang Hospital Southern Medical University Guangzhou Guangdong 510515 China Department of Neurosurgery West China Hospital of Sichuan University Chengdu Sichuan 610041 China Department of Neurosurgery Peking Union Medical College Hospital Beijing 100032 China Department of Neurosurgery General Hospital Tianjin Medical University Tianjin 300070 China Department of Neurosurgery Xijing Hospital The Fourth Military Medical University Xi'an Shaanxi 710032 China

Background： The radiochemotherapy regimen concomitantly employing temozolomide （TMZ） chemotherapy and radiotherapy （RT） 4 weeks after surgery, followed by 6 cycles of TMZ is a common treatment for glioblastoma （GBM）. However, its median overall survival （OS） is only 14.6 months. This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Methods： A randomized, parallel group, open-label study of 99 newly diagnosed GBM patients was conducted at 10 independent Chinese neurosurgical departments from June 2008 to June 2012. Patients were treated with concomitant radiochemotherapy regimen plus early postsurgical temozolomide （early TMZ group） or standard concomitant radiochemotherapy regimen （control group）. Overall response was assessed based on objective tumor assessments, administration ofcorticosteroid and neurological status test. Hematological, biochemical, laboratory, adverse event （AE）, and neurological condition were measured for 24 months of tbllow-up. The primary efficacy endpoint of this study was overall survival （OS）. The secondary endpoint was progression free survival （PFS）. Results： The median OS time in the early TMZ group was 17.6 months, compared with 13.2 months in the control group （log-rank test P 0.021 ）. In addition, the OS rate in the early TMZ group was higher at 6, 12, and 18 months than in the control group, respectively （P 〈 0.05）. The median PFS time was 8.7 months in the early TMZ group and 10.4 months in the control group （log-rank test P = 0.695）. AEs occurred in 29 （55.8%） and 31（73.8%） patients respectively in early and control groups, including nausea （15.4% vs. 33.3%）, vomiting （7.7% vs. 28.6%）, fever （7.7% vs. 11.9%）, and headache （3.8% vs. 23.8%）. Only 30.8% and 33.3% were drug-related, respectively. Conclusions： Addition of TMZ chemotherapy in the early break of the standard concomitant radiochemotherapy regimen was well tolerated and significantly improved the O

关键词： Chemoradiotherapy chemotherapy： glioblastoma Malignant Glioma Temozolomide

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