Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases - A randomized controlled trial
Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases - A randomized controlled trial
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DOI：
10.1001/jama.295.21.2483
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发表时间：
2006-06-07
影响因子：
120.7
通讯作者：
Kobashi, Gen
中科院分区：
文献类型：
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作者：
Aoyama, Hidefumi;Shirato, Hiroki;Kobashi, Gen
在脑转移患者中，目前尚不清楚与单独的SRS相比，在立体定向放射手术（SRS）中加入预先全脑放疗（WBRT）是否对死亡率或神经功能有有益的影响。目的探讨WBRT联合SRS是否能改善患者的生存、脑肿瘤控制、功能保存率和神经系统死亡频率。1999年10月至2003年12月，在日本的11家医院进行了一项随机对照试验，纳入了132例1至4例脑转移患者，每个患者的直径小于3cm。干预措施患者被随机分配接受WBRT + SRS（65例）或单独SRS（67例）。主要终点为总生存期；次要终点为脑肿瘤复发、脑修复治疗、功能保存、辐射毒性作用和死亡原因。结果WBRT + SRS组的中位生存时间和1年精算生存率分别为7.5个月和38.5%(95%可信区间，26.7% ~ 50.3%)，单独SRS组的中位生存时间和1年精算生存率分别为8.0个月和28.4%(95%可信区间，17.6% ~ 39.2%)(P=；42)。WBRT + SRS组12个月脑肿瘤复发率为46.8%，单独SRS组为76.4% （P < 0.05）
Context In patients with brain metastases, it is unclear whether adding up-front whole-brain radiation therapy (WBRT) to stereotactic radiosurgery (SRS) has beneficial effects on mortality or neurologic function compared with SRS alone.Objective To determine if WBRT combined with SRS results in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.Design, Setting, and Patients Randomized controlled trial of 132 patients with 1 to 4 brain metastases, each less than 3 cm in diameter, enrolled at 11 hospitals in Japan between October 1999 and December 2003.Interventions Patients were randomly assigned to receive WBRT plus SRS ( 65 patients) or SRS alone ( 67 patients).Main Outcome Measures The primary end point was overall survival; secondary end points were brain tumor recurrence, salvage brain treatment, functional preservation, toxic effects of radiation, and cause of death.Results The median survival time and the 1-year actuarial survival rate were 7.5 months and 38.5% (95% confidence interval, 26.7%-50.3%) in the WBRT + SRS group and 8.0 months and 28.4% (95% confidence interval, 17.6%-39.2%) for SRS alone (P=. 42). The 12-month brain tumor recurrence rate was 46.8% in the WBRT + SRS group and 76.4% for SRS alone group ( P