Randomized trial of chemoradiotherapy and adjuvant chemotherapy with nimustine (ACNU) versus nimustine plus procarbazine for newly diagnosed anaplastic astrocytoma and glioblastoma (JCOG0305)

作     者：Shibui S Narita Y Mizusawa J Beppu T Ogasawara K Sawamura Y Kobayashi H Nishikawa R Mishima K Muragaki Y Maruyama T Kuratsu J Nakamura H Kochi M Minamida Y Yamaki T Kumabe T Tominaga T Kayama T Sakurada K Nagane M Kobayashi K Nakamura H Ito T Yazaki T Sasaki H Tanaka K Takahashi H Asai A Todo T Wakabayashi T Takahashi J Takano S Fujimaki T Sumi M Miyakita Y Nakazato Y Sato A Fukuda H Nomura K Shibui S,Narita Y,Mizusawa J,Beppu T,Ogasawara K,Sawamura Y,Kobayashi H,Nishikawa R,Mishima K,Muragaki Y,Maruyama T,Kuratsu J,Nakamura H,Kochi M,Minamida Y,Yamaki T,Kumabe T,Tominaga T,Kayama T,Sakurada K,Nagane M,Kobayashi K,Nakamura H,Ito T,Yazaki T,Sasaki H,Tanaka K,Takahashi H,Asai A,Todo T,Wakabayashi T,Takahashi J,Takano S,Fujimaki T,Sumi M,Miyakita Y,Nakazato Y,Sato A,Fukuda H,Nomura K.Department of Neurosurgery and Neuro-Oncology,National Cancer Center Hospital,5-1-1 Tsukiji,Chuo-ku,Tokyo 104-0045,Japan.

作者机构：Department of Neurosurgery and Neuro-OncologyNational Cancer Center Hospital5-1-1 TsukijiChuo-kuTokyo 104-0045Japan 

出 版 物：《中国神经肿瘤杂志》 (Chinese Journal of Neuro-Oncology)

年 卷 期：2013年第11卷第1期

页      面：21-21页

学科分类：0710[理学-生物学] 07[理学] 08[工学] 071006[理学-神经生物学] 082504[工学-人机与环境工程] 0825[工学-航空宇航科学与技术] 

主　　题：星形细胞 母细胞 随机试验 放疗 胶质 变性 化疗 MGMT 

摘      要：Objectives: Glioblastoma(GBM) is one of the worst cancers in terms of *** therapy consists of resection with concomitant *** to nimustine hydrochloride(ACNU),an alkylating agent,has been linked to methylguanine DNA methyltransferase(MGMT).Daily administration of procarbazine(PCZ) has been reported to decrease MGMT *** study investigated the efficacy of ACNU + PCZ compared to ACNU alone for GBM and anaplastic astrocytoma(AA).Methods: Patients(20-69 years) who had newly diagnosed AA and GBM were randomly assigned to receive radiotherapy with ACNU alone or with ACNU + *** primary endpoint was overall survival(OS).This was designed as a phase Ⅱ/Ⅲ trial with a total sample size of 310 patients and was registered as UMIN-CTR ***: After 111 patients from 19 centers in Japan were enrolled,this study was terminated early because temozolomide was newly approved in *** median OS and median progression-free survival(PFS) with ACNU alone(n = 55) or ACNU + PCZ(n = 56) in the intention-to-treat population were 27.4 and 22.4 months(P = 0.75),and 8.6 and 6.9 months,*** median OS and median PFS of the GBM subgroup treated with ACNU alone(n = 40) or ACNU + PCZ(n = 41) were 19.0 and 19.5 months,and 6.2 and 6.3 months,*** 3/4 hematologic adverse events occurred in more than 40% of patients in both arms,and 27% of patients discontinued treatment because of adverse ***: The addition of PCZ to ACNU was not beneficial,in comparison with ACNU alone,for patients with newly diagnosed AA and GBM.