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 me...
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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.
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