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

引用

中国神经肿瘤杂志 2013年第1期11卷 21-21页

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 Department of Neurosurgery and Neuro-Oncology National Cancer Center Hospital5-1-1 TsukijiChuo-kuTokyo 104-0045Japan

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.

关键词：星形细胞母细胞随机试验放疗胶质变性化疗 mGmT

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