ムラガキ　ヨシヒロ   Muragaki Yoshihiro   村垣　善浩    所属   医学部 医学科（東京女子医科大学病院）    職種   客員教授
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	JCOG0911 INTEGRA study: a randomized screening phase II trial of interferonβ plus temozolomide in comparison with temozolomide alone for newly diagnosed glioblastoma.
掲載誌名	正式名：Journal of neuro-oncology 略　 称：J Neurooncol ISSNコード：15737373/0167594X
掲載区分	国外
巻・号・頁	138(3),pp.627-636
著者・共著者	WAKABAYASHI Toshihiko†, NATSUME Atsushi, MIZUSAWA Junki, KATAYAMA Hiroshi, FUKUDA Haruhiko, SUMI Minako, NISHIKAWA Ryo, NARITA Yoshitaka, MURAGAKI Yoshihiro, MARUYAMA Takashi, ITO Tamio, BEPPU Takaaki, NAKAMURA Hideo, KAYAMA Takamasa, SATO Shinya, NAGANE Motoo, MISHIMA Kazuhiko, NAKASU Yoko, KURISU Kaoru, YAMASAKI Fumiyuki, SUGIYAMA Kazuhiko, ONOSHI Takanori, IWADATE Yasuo, TERASAKI Mizuhiko, KOBAYASHI Hiroyuki, MATSUMURA Akira, ISHIKAWA Eiichi, SASAKI Hikaru, MUKASA Akitake, MATSUO Takayuki, HIRANO Hirofumi, KUMABE Toshihiro, SHINOURA Nobusada, HASHIMOTO Naoya, AOKI Tomokazu, ASAI Akio, ABE Tatsuya, YOSHINO Atsuo, ARAKAWA Yoshiki, ASANO Kenichiro, YOSHIMOTO Koji, SHIBUI Soichiro
発行年月	2018/07
概要	PURPOSE:This study explored the superiority of temozolomide (TMZ) + interferonβ (IFNβ) to standard TMZ as treatment for newly diagnosed glioblastoma (GBM) via randomized phase II screening design.EXPERIMENTAL DESIGN:Eligibility criteria included histologically proven GBM, with 50% of the tumor located in supratentorial areas, without involvement of the optic, olfactory nerves, and pituitary gland and without multiple lesions and dissemination. Patients in the TMZ + radiotherapy (RT) arm received RT (2.0 Gy/fr/day, 30 fr) with TMZ (75 mg/m2RESULTS:Between Apr 2010 and Jan 2012, 122 patients were randomized. The median OS with TMZ + RT and TMZ + IFNβ + RT was 20.3 and 24.0 months (HR 1.00, 95% CI 0.65-1.55; one-sided log rank P = 0.51). The median progression-free survival times were 10.1 and 8.5 months (HR 1.25, 95% CI 0.85-1.84). The incidence of neutropenia with the TMZ + RT and the TMZ + IFNβ + RT (grade 3-4, CTCAE version 3.0) was 12.7 versus 20.7% during concomitant period and was 3.6 versus 9.3% during maintenance period. The incidence of lymphopenia was 54.0 versus 63.8% and 34.5 versus 41.9%.CONCLUSIONS:TMZ + IFNβ + RT is not considered as a candidate for the following phase III trial, and TMZ + RT remained to be a most promising treatment. This trial was registered with the UMIN Clinical Trials Registry: UMIN000003466.
DOI	10.1007/s11060-018-2831-7
PMID	29557060