Yamamoto Masaaki, Serizawa Toru, Higuchi Yoshinori, Sato Yasunori, Kawagishi Jun, Yamanaka Kazuhiro, Shuto Takashi, Akabane Atsuya, Jokura Hidefumi, Yomo Shoji, Nagano Osamu, Aoyama Hidefumi
Katsuta Hospital Mito GammaHouse, Hitachinaka, Japan.
Tokyo Gamma Unit Center, Tsukiji Neurological Clinic, Tokyo, Japan.
Int J Radiat Oncol Biol Phys. 2017 Sep 1;99(1):31-40. doi: 10.1016/j.ijrobp.2017.04.037. Epub 2017 Aug 7.
The JLGK0901 study showed the noninferiority of stereotactic radiosurgery (SRS) alone as initial treatment of 5 to 10 brain metastases (BMs) compared with 2 to 4 BMs in terms of overall survival and most secondary endpoints (Lancet Oncol 2014;15:387-95). However, observation periods were not long enough to allow confirmation of the long-term safety of SRS alone in patients with 5 to 10 BMs.
This was a prospective observational study of Gamma Knife SRS-treated patients with 1 to 10 newly diagnosed BMs enrolled at 23 facilities between March 1, 2009, and February 15, 2012.
The 1194 eligible patients were categorized into the following groups: group A, 1 tumor (n=455); group B, 2 to 4 tumors (n=531); and group C, 5 to 10 tumors (n=208). Cumulative rates of Mini-Mental State Examination (MMSE) score maintenance (MMSE score decrease <3 from baseline) determined with a competing risk analysis of groups A, B, and C were 93%, 91%, and 92%, respectively, at the 12th month after SRS; 91%, 89%, and 91%, respectively, at the 24th month; 89%, 88%, and 89%, respectively, at the 36th month; and 87%, 86%, and 89%, respectively, at the 48th month (hazard ratio [HR] of group A vs group B, 0.719; 95% confidence interval [CI], 0.437-1.172; P=.18; HR of group B vs group C, 1.280; 95% CI, 0.696-2.508; P=.43). During observations ranging from 0.3 to 67.5 months (median, 12.0 months; interquartile range, 5.8-26.5 months), as of December 2014, 145 patients (12.1%) had SRS-induced complications. Cumulative complication incidences by competing risk analysis for groups A, B, and C were 7%, 8%, and 6%, respectively, at the 12th month after SRS; 10%, 11%, and 11%, respectively, at the 24th month; 11%, 11%, and 12%, respectively, at the 36th month; and 12%, 12%, and 13%, respectively, at the 48th month (HR of group A vs group B, 0.850; 95% CI, 0.592-1.220; P=.38; HR of group B vs group C, 1.052; 95% CI, 0.666-1.662, P=.83). Leukoencephalopathy occurred in 12 of the 1074 patients (1.1%) with follow-up magnetic resonance imaging and was detected after salvage whole-brain radiation therapy in 11 of these 12 patients. In these 11 patients, leukoencephalopathy was detected by magnetic resonance imaging 5.2 to 21.2 months (median, 11.0 months; interquartile range, 7.0-14.4 months) after whole-brain radiation therapy.
Neither MMSE score maintenance nor post-SRS complication incidence differed among groups A, B, and C. This longer-term follow-up study further supports the already-reported noninferiority hypothesis of SRS alone for patients with 5 to 10 BMs versus 2 to 4 BMs.
JLGK0901研究表明，在总生存期和大多数次要终点方面，立体定向放射外科治疗（SRS）单独作为5至10个脑转移瘤（BMs）的初始治疗与2至4个BMs相比具有非劣效性（《柳叶刀·肿瘤学》2014年；15:387 - 95）。然而，观察期不够长，无法确认SRS单独治疗5至10个BMs患者的长期安全性。
这是一项对2009年3月1日至2012年2月15日期间在23个机构登记的接受伽玛刀SRS治疗的1至10个新诊断BMs患者的前瞻性观察研究。
1194例符合条件的患者被分为以下几组：A组，1个肿瘤（n = 455）；B组，2至4个肿瘤（n = 531）；C组，5至10个肿瘤（n = 208）。通过对A、B、C组进行竞争风险分析确定的简易精神状态检查表（MMSE）评分维持率（MMSE评分较基线下降<3分），在SRS后第12个月分别为93%、91%和92%；第24个月分别为91%、89%和91%；第36个月分别为89%、88%和89%；第48个月分别为87%、86%和89%（A组与B组的风险比[HR]，0.719；95%置信区间[CI]，0.437 - 1.172；P = 0.18；B组与C组的HR，1.280；95% CI，0.696 - 2.508；P = 0.43）。在0.
