MARUYAMA Takashi    Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine    Position
Article types	Original article
Language	English
Peer review	Peer reviewed
Title	Randomized trial of chemoradiotherapy and adjuvant chemotherapy with nimustine (ACNU) versus nimustine plus procarbazine for newly diagnosed anaplastic astrocytoma and glioblastoma (JCOG0305)
Journal	Formal name：Cancer Chemotherapy and Pharmacology Abbreviation：Cancer Chemother Pharmacol ISSN code：03445704/14320843
Domestic / Foregin	Foregin
Publisher	Springer-Verlag
Volume, Issue, Page	71(2),pp.511-521
Author and coauthor	SHIBUI Soichiro† , NARITA Yoshitaka , MIZUSAWA Junki , BEPPU Takaaki , OGASAWARA Kuniaki , SAWAMURA Yutaka , KOBAYASHI Hiroyuki , NISHIKAWA Ryo , MISHIMA Kazuhiko, MURAGAKI Yoshihiro, MARUYAMA Takashi, KURATSU Junichi , NAKAMURA Hideo, KOCHI Masato , MINAMIDA Yoshio , YAMAKI Toshiaki , KUMABE Toshihiro , TOMINAGA Teiji , KAYAMA Takamasa , SAKURADA Kaori , KOBAYASHI Keiichi , NAKAMURA Hirohiko , ITO Tamio, YAZAKI Takahito , SASAKI Hikaru , TANAKA Katsuyuki , TAKAHASHI Hideaki , ASAI Akio, TODO Tomoki , WAKABAYASHI Toshihiko , TAKAHASHI Jun , TAKANO Shingo , FUJIMAKI Takamitsu , SUMI Minako , MIYAKITA Yasuji , NAKAZATO Yoichi , SATO Akihiro , FUKUDA Haruhiko , NOMURA Kazuhiro
Publication date	2013/02
Summary	Glioblastoma (GBM) is one of the worst cancers in terms of prognosis. Standard therapy consists of resection with concomitant chemoradiotherapy. Resistance 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 activity. This study investigated the efficacy of ACNU + PCZ compared to ACNU alone for GBM and anaplastic astrocytoma (AA).|Patients (20-69 years) who had newly diagnosed AA and GBM were randomly assigned to receive radiotherapy with ACNU alone or with ACNU + PCZ. The primary endpoint was overall survival (OS). This was designed as a phase II/III trial with a total sample size of 310 patients andwas registered as UMIN-CTR C000000108.|After 111 patients from 19 centers in Japan were enrolled, this study was terminated early because temozolomide was newly approved in Japan. The 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, respectively. The 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, respectively. Grade 3/4 hematologic adverse events occurred in more than 40 % of patients in both arms, and 27 % of patients discontinued treatment because of adverse events.|The addition of PCZ to ACNU was not beneficial, in comparison with ACNU alone, for patients with newly diagnosed AA and GBM.
DOI	10.1007/s00280-012-2041-5
Document No.	23228988