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Abstract
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.

Author information

Kayama T1, Sato S1, Sakurada K1, Mizusawa J1, Nishikawa R1, Narita Y1, Sumi M1, Miyakita Y1, Kumabe T1, Sonoda Y1, Arakawa Y1, Miyamoto S1, Beppu T1, Sugiyama K1, Nakamura H1, Nagane M1, Nakasu Y1, Hashimoto N1, Terasaki M1, Matsumura A1, Ishikawa E1, Wakabayashi T1, Iwadate Y1, Ohue S1, Kobayashi H1, Kinoshita M1, Asano K1, Mukasa A1, Tanaka K1, Asai A1, Nakamura H1, Abe T1, Muragaki Y1, Iwasaki K1, Aoki T1, Watanabe T1, Sasaki H1, Izumoto S1, Mizoguchi M1, Matsuo T1, Takeshima H1, Hayashi M1, Jokura H1, Mizowaki T1, Shimizu E1, Shirato H1, Tago M1, Katayama H1, Fukuda H1, Shibui S1; Japan Clinical Oncology Group.
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Takamasa Kayama, Shinya Sato, Kaori Sakurada, Yukihiko Sonoda, Yamagata University Faculty of Medicine, Yamagata; Junki Mizusawa, Yoshitaka Narita, Yasuji Miyakita, Hiroshi Katayama, Haruhiko Fukuda, Soichiro Shibui, National Cancer Center Hospital; Minako Sumi, Cancer Institute Hospital; Akitake Mukasa, The University of Tokyo Graduate School of Medicine; Yoshihiro Muragaki, Motohiro Hayashi, Tokyo Women's Medical University; Takao Watanabe, Nihon University School of Medicine; Hikaru Sasaki, Keio University School of Medicine; Masao Tago, Teikyo University Mizonokuchi Hospital; Motoo Nagane, Kyorin University Faculty of Medicine, Tokyo; Ryo Nishikawa, Saitama Medical University International Medical Center, Saitama; Toshihiro Kumabe, Tohoku University Graduate School of Medicine; Eiji Shimizu, Tohoku University Hospital; Hidefumi Jokura, Furukawa Seiryo Hospital, Miyagi; Yoshiki Arakawa, Susumu Miyamoto, Takashi Mizowaki, Kyoto University Graduate School of Medicine, Kyoto; Takaaki Beppu, Iwate Medical University, Morioka; Kazuhiko Sugiyama, Hiroshima University Hospital, Hiroshima; Hirohiko Nakamura, Nakamura Memorial Hospital, Sapporo; Yoko Nakasu, Shizuoka Cancer Center, Shizuoka; Naoya Hashimoto, Osaka University Graduate School of Medicine; Manabu Kinoshita, Osaka International Cancer Institute; Akio Asai, Kansai Medical University; Koichi Iwasaki, Kitano Hospital; Tomokazu Aoki, Kitano Medical Research Institute and Hospital, Osaka; Mizuhiko Terasaki, Kurume University, Kurume; Akira Matsumura, Eiichi Ishikawa, University of Tsukuba, Tsukuba; Toshihiko Wakabayashi, Nagoya University, Nagoya; Yasuo Iwadate, Chiba University, Chiba; Shiro Ohue, Ehime University Graduate School of Medicine, Ehime; Hiroyuki Kobayashi, Hiroki Shirato, Hokkaido University Graduate School of Medicine, Hokkaido; Kenichiro Asano, Hirosaki University Graduate School of Medicine, Hirosaki City; Katsuyuki Tanaka, St Marianna University School of Medicine, Kanagawa; Hideo Nakamura, Kumamoto University, Kumamoto; Tatsuya Abe, Oita University Faculty of Medicine, Oita; Shuichi Izumoto, Hyogo College of Medicine, Hyogo; Masahiro Mizoguchi, Kyushu University, Fukuoka; Takayuki Matsuo, Nagasaki Graduate School of Biomedical Sciences, Nagasaki; and Hideo Takeshima, University of Miyazaki, Miyazaki, Japan.