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
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
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DOI：
10.1200/jco.2018.78.6186
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发表时间：
2018-11-20
影响因子：
45.3
通讯作者：
Shibui, Soichiro
中科院分区：
文献类型：
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作者：
Kayama, Takamasa;Sato, Shinya;Shibui, Soichiro
目的尽管全脑放射治疗 (WBRT) 已成为脑转移瘤 (BM) 的标准治疗方法，但立体定向放射外科 (SRS) 越来越受到青睐，以避免认知功能障碍；然而，尚不清楚SRS治疗是否与WBRT或WBRT加SRS治疗一样有效。因此，我们评估了 BM 患者中挽救性 SRS 相对于 WBRT 的非劣效性。 患者和方法 年龄 20 至 79 岁、体能状态评分为 0 至 2 和 3 分（如果仅由神经功能缺损引起）且手术切除 4 个或更少的 BM 且仅有 1 个病变直径 > 3 cm 的患者符合资格。手术后 21 天内，患者被随机分配至 WBRT 组或挽救性 SRS 组。主要终点是总生存期。使用单侧 0.05。 结果 2006 年 1 月至 2014 年 5 月期间，WBRT 组和挽救性 SRS 组分别招募了 137 名和 134 名患者。两组的中位总生存期均为 15.6 个月（风险比，1.05；90% CI，0.83 至 1.33；单侧非劣效性 P = 0.027）。 WBRT 组患者的中位颅内无进展生存期（10.4 个月）长于挽救 SRS 组患者的中位无进展生存期（4.0 个月）。 12 个月时，简易精神状态检查和表现状态评分未恶化的患者比例在两组中相似；然而，入组后 91 天后，WBRT 组中有 16.4% 的患者出现 2 至 4 级认知功能障碍，而 SRS 组中只有 7.7% 的患者出现这种情况 (P = 0.048)。 结论挽救 SRS 并不劣于 WBRT，可以作为 BM 为 4 或更少的患者的标准疗法。
PurposeWhereas 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 MethodsPatients age 20 to 79 years old with performance status scores of 0 to 2and 3 if caused only by neurologic deficitsand 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 of .05 was used.ResultsBetween 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).ConclusionSalvage SRS is noninferior to WBRT and can be established as a standard therapy for patients with four or fewer BMs.