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

Takamasa Kayama, Shinya Sato, Kaori Sakurada, Junki Mizusawa, Ryo Nishikawa, Yoshitaka Narita, Minako Sumi, Yasuji Miyakita, Toshihiro Kumabe, Yukihiko Sonoda, Yoshiki Arakawa, Susumu Miyamoto, Takaaki Beppu, Kazuhiko Sugiyama, Hirohiko Nakamura, Motoo Nagane, Yoko Nakasu, Naoya Hashimoto, Mizuhiko Terasaki, Akira MatsumuraEiichi Ishikawa, Toshihiko Wakabayashi, Yasuo Iwadate, Shiro Ohue, Hiroyuki Kobayashi, Manabu Kinoshita, Kenichiro Asano, Akitake Mukasa, Katsuyuki Tanaka, Akio Asai, Hideo Nakamura, Tatsuya Abe, Yoshihiro Muragaki, Koichi Iwasaki, Tomokazu Aoki, Takao Watanabe, Hikaru Sasaki, Shuichi Izumoto, Masahiro Mizoguchi, Takayuki Matsuo, Hideo Takeshima, Motohiro Hayashi, Hidefumi Jokura, Takashi Mizowaki, Eiji Shimizu, Hiroki Shirato, Masao Tago, Hiroshi Katayama, Haruhiko Fukuda, Soichiro Shibui

研究成果: ジャーナルへの寄稿記事

14 引用 (Scopus)

抄録

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 a 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.

元の言語英語
ページ(範囲)3282-3289
ページ数8
ジャーナルJournal of Clinical Oncology
36
発行部数33
DOI
出版物ステータス出版済み - 11 20 2018

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Radiosurgery
Radiotherapy
Randomized Controlled Trials
Neoplasm Metastasis
Brain
Survival
Neurologic Manifestations
Ambulatory Surgical Procedures
Disease-Free Survival
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

これを引用

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. / Kayama, Takamasa; Sato, Shinya; Sakurada, Kaori; Mizusawa, Junki; Nishikawa, Ryo; Narita, Yoshitaka; Sumi, Minako; Miyakita, 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; Shibui, Soichiro.

:: Journal of Clinical Oncology, 巻 36, 番号 33, 20.11.2018, p. 3282-3289.

研究成果: ジャーナルへの寄稿記事

Kayama, T, Sato, S, Sakurada, K, Mizusawa, J, Nishikawa, R, Narita, Y, Sumi, M, Miyakita, Y, Kumabe, T, Sonoda, Y, Arakawa, Y, Miyamoto, S, Beppu, T, Sugiyama, K, Nakamura, H, Nagane, M, Nakasu, Y, Hashimoto, N, Terasaki, M, Matsumura, A, Ishikawa, E, Wakabayashi, T, Iwadate, Y, Ohue, S, Kobayashi, H, Kinoshita, M, Asano, K, Mukasa, A, Tanaka, K, Asai, A, Nakamura, H, Abe, T, Muragaki, Y, Iwasaki, K, Aoki, T, Watanabe, T, Sasaki, H, Izumoto, S, Mizoguchi, M, Matsuo, T, Takeshima, H, Hayashi, M, Jokura, H, Mizowaki, T, Shimizu, E, Shirato, H, Tago, M, Katayama, H, Fukuda, H & Shibui, S 2018, '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', Journal of Clinical Oncology, 巻. 36, 番号 33, pp. 3282-3289. https://doi.org/10.1200/JCO.2018.78.6186
Kayama, Takamasa ; Sato, Shinya ; Sakurada, Kaori ; Mizusawa, Junki ; Nishikawa, Ryo ; Narita, Yoshitaka ; Sumi, Minako ; Miyakita, 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 ; Shibui, Soichiro. / 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. :: Journal of Clinical Oncology. 2018 ; 巻 36, 番号 33. pp. 3282-3289.
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title = "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",
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 a 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 = "Takamasa Kayama and Shinya Sato and Kaori Sakurada and Junki Mizusawa and Ryo Nishikawa and Yoshitaka Narita and Minako Sumi and Yasuji Miyakita and Toshihiro Kumabe and Yukihiko Sonoda and Yoshiki Arakawa and Susumu Miyamoto and Takaaki Beppu and Kazuhiko Sugiyama and Hirohiko Nakamura and Motoo Nagane and Yoko Nakasu and Naoya Hashimoto and Mizuhiko Terasaki and Akira Matsumura and Eiichi Ishikawa and Toshihiko Wakabayashi and Yasuo Iwadate and Shiro Ohue and Hiroyuki Kobayashi and Manabu Kinoshita and Kenichiro Asano and Akitake Mukasa and Katsuyuki Tanaka and Akio Asai and Hideo Nakamura and Tatsuya Abe and Yoshihiro Muragaki and Koichi Iwasaki and Tomokazu Aoki and Takao Watanabe and Hikaru Sasaki and Shuichi Izumoto and Masahiro Mizoguchi and Takayuki Matsuo and Hideo Takeshima and Motohiro Hayashi and Hidefumi Jokura and Takashi Mizowaki and Eiji Shimizu and Hiroki Shirato and Masao Tago and Hiroshi Katayama and Haruhiko Fukuda and Soichiro Shibui",
year = "2018",
month = "11",
day = "20",
doi = "10.1200/JCO.2018.78.6186",
language = "English",
volume = "36",
pages = "3282--3289",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "33",

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TY - JOUR

T1 - Effects of surgery with salvage stereotactic radiosurgery versus surgery with whole-brain radiation therapy in patients with one to four brain metastases (JCOG0504)

T2 - A Phase III, noninferiority, randomized controlled trial

AU - Kayama, Takamasa

AU - Sato, Shinya

AU - Sakurada, Kaori

AU - Mizusawa, Junki

AU - Nishikawa, Ryo

AU - Narita, Yoshitaka

AU - Sumi, Minako

AU - Miyakita, Yasuji

AU - Kumabe, Toshihiro

AU - Sonoda, Yukihiko

AU - Arakawa, Yoshiki

AU - Miyamoto, Susumu

AU - Beppu, Takaaki

AU - Sugiyama, Kazuhiko

AU - Nakamura, Hirohiko

AU - Nagane, Motoo

AU - Nakasu, Yoko

AU - Hashimoto, Naoya

AU - Terasaki, Mizuhiko

AU - Matsumura, Akira

AU - Ishikawa, Eiichi

AU - Wakabayashi, Toshihiko

AU - Iwadate, Yasuo

AU - Ohue, Shiro

AU - Kobayashi, Hiroyuki

AU - Kinoshita, Manabu

AU - Asano, Kenichiro

AU - Mukasa, Akitake

AU - Tanaka, Katsuyuki

AU - Asai, Akio

AU - Nakamura, Hideo

AU - Abe, Tatsuya

AU - Muragaki, Yoshihiro

AU - Iwasaki, Koichi

AU - Aoki, Tomokazu

AU - Watanabe, Takao

AU - Sasaki, Hikaru

AU - Izumoto, Shuichi

AU - Mizoguchi, Masahiro

AU - Matsuo, Takayuki

AU - Takeshima, Hideo

AU - Hayashi, Motohiro

AU - Jokura, Hidefumi

AU - Mizowaki, Takashi

AU - Shimizu, Eiji

AU - Shirato, Hiroki

AU - Tago, Masao

AU - Katayama, Hiroshi

AU - Fukuda, Haruhiko

AU - Shibui, Soichiro

PY - 2018/11/20

Y1 - 2018/11/20

N2 - 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 a 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.

AB - 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 a 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.

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U2 - 10.1200/JCO.2018.78.6186

DO - 10.1200/JCO.2018.78.6186

M3 - Article

AN - SCOPUS:85056616718

VL - 36

SP - 3282

EP - 3289

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 33

ER -