ハヤシ　モトヒロ   HAYASHI Motohiro   林　基弘    所属   医学部 医学科（東京女子医科大学病院）    職種   教授
論文種別	総説
言語種別	英語
査読の有無	査読なし
表題	Effects of Surgery With Salvage Stereotactic Radiosurgery Versus Surgery With Whole-Brain Radiation Therapy in Patients With One to Four Brain Metastases (JCOG0504): A Phase III, Noninferiority, Randomized Controlled Trial.
掲載誌名	正式名：Journal of clinical oncology : official journal of the American Society of Clinical Oncology 略　 称：J Clin Oncol ISSNコード：15277755/0732183X(Linking)
掲載区分	国外
巻・号・頁	36(33),pp.3282-3289
著者・共著者	KAYAMA Takamasa†, SATO Shinya, SAKURADA Kaori, MIZUSAWA Junki, NISHIKAWA Ryo, NARITA Yoshitaka, SUMI Minako, NIYAKITA Yasuji, KUMABE Toshihiro, SONODA Yukihiko, ARAKAWA Yoshiki, MIYAMOTO Susumu, BEPPU Takaaki, SUGIYAMA Kazuhiko, NAKAMURA Hirohiko, NAGANE Motoo, NAKASU Yoko, HASHIMOTO Naoya, TERASAKI Mizuhiko, MATSUMURA Akira, ISHIKAWA Eiichi, WAKABAYASHI Toshihiko, IWADATE Yasuo, OHUE Shiro, KOBAYASHI Hiroyuki, KINOSHITA Manabu, ASANO Kenichiro, MUKASA Akitake, TANAKA Katsuyuki, ASAI Akio, NAKAMURA Hideo, ABE Tatsuya, MURAGAKI Yoshihiro, IWASAKI Koichi, AOKI Tomokazu, WATANABE Takao, SASAKI Hikaru, IZUMOTO Shuichi, MIZOGUCHI Masahiro, MATSUO Takayuki, TAKESHIMA Hideo, HAYASHI Motohiro, JOKURA Hidefumi, MIZOWAKI Takashi, SHIMIZU Eiji, SHIRATO Hiroki, TAGO Masao, KATAYAMA Hiroshi, FUKUDA Haruhiko
発行年月	2018/06
概要	Purpose Whereas whole-brain radiotherapy (WBRT) has been the standard treatment of brain metastases (BMs), stereotactic radiosurgery (SRS) is increasingly preferred to avoid cognitive dysfunction; however, it has not been clearly determined whether treatment with SRS is as effective as that with WBRT or WBRT plus SRS. We thus assessed the noninferiority of salvage SRS to WBRT in patients with BMs. Patients and Methods Patients age 20 to 79 years old with performance status scores of 0 to 2-and 3 if caused only by neurologic deficits-and with four or fewer surgically resected BMs with only one lesion > 3 cm in diameter were eligible. Patients were randomly assigned to WBRT or salvage SRS arms within 21 days of surgery. The primary end point was overall survival. A one-sided α of .05 was used. Results Between January 2006 and May 2014, 137 and 134 patients were enrolled in the WBRT and salvage SRS arms, respectively. Median overall survival was 15.6 months in both arms (hazard ratio, 1.05; 90% CI, 0.83 to 1.33; one-sided P for noninferiority = .027). Median intracranial progression-free survival of patients in the WBRT arm (10.4 months) was longer than that of patients in the salvage SRS arm (4.0 months). The proportions of patients whose Mini-Mental Status Examination and performance status scores that did not worsen at 12 months were similar in both arms; however, 16.4% of patients in the WBRT arm experienced grade 2 to 4 cognitive dysfunction after 91 days postenrollment, whereas only 7.7% of those in the SRS arm did ( P = .048). Conclusion Salvage SRS is noninferior to WBRT and can be established as a standard therapy for patients with four or fewer BMs.
DOI	10.1200/JCO.2018.78.6186
PMID	29924704