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一项针对非小细胞肺癌无症状性脑寡转移患者立体定向放射外科治疗(SRS)与观察的随机 III 期临床试验。

A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer.

机构信息

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.

出版信息

Ann Oncol. 2015 Apr;26(4):762-768. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23.

DOI:10.1093/annonc/mdu584
PMID:25538174
Abstract

BACKGROUND

It is unclear whether treating brain metastasis before starting systemic chemotherapy can improve survival compared with upfront chemotherapy in non-small-cell lung cancer (NSCLC) with asymptomatic cerebral oligo-metastases.

PATIENTS AND METHODS

We undertook a randomized, controlled trial of 105 patients with one to four brain metastases, admitted to Samsung Medical Center between 2008 and 2013. Patients were randomly assigned to receive stereotactic radiosurgery (SRS) (49 patients) followed by chemotherapy or upfront chemotherapy (49 patients). The primary end point was overall survival (OS) and secondary end points included central nervous system (CNS) progression-free survival, progression to symptomatic brain metastasis and brain functional outcome.

RESULTS

The median age was 58 years (range, 29-85) with ECOG 0-1 performance status, and 40% of patients were never smokers. Most patients had adenocarcinoma, and about half of patients had only one brain metastasis, while the rest had multiple cerebral metastases. The median OS time was 14.6 months [95% confidence interval (CI), 9.2-20.0] in the SRS group and 15.3 months (95% CI, 7.2-23.4) for the upfront chemotherapy group (P = 0.418). There was no significant difference in time to CNS disease progression [median, 9.4 months (SRS) versus 6.6 months (upfront chemotherapy), P = 0.248]. Symptomatic progression of brain metastases was observed more frequently in the upfront chemotherapy group (26.5%) than the SRS group (18.4%) but without statistical significance.

CONCLUSIONS

Although this study included smaller sample size than initially anticipated due to early termination, SRS followed by chemotherapy did not improve OS in oligo-brain metastases NSCLC patients compared with upfront chemotherapy. Further study with large number of patients should be needed to confirm the use of upfront chemotherapy alone in this subgroup of patients.

CLINICAL TRIALS NUMBER

NCT01301560.

摘要

背景

对于无症状性寡脑转移的非小细胞肺癌(NSCLC)患者,在开始全身化疗前治疗脑部转移是否能改善生存,目前尚不清楚。

患者和方法

我们对 2008 年至 2013 年间在三星医疗中心收治的 105 例 1 至 4 个脑转移灶的患者进行了一项随机对照试验。患者被随机分配接受立体定向放射外科(SRS)(49 例)加化疗或初始化疗(49 例)。主要终点为总生存期(OS),次要终点包括中枢神经系统(CNS)无进展生存期、进展为有症状脑转移和脑功能结局。

结果

中位年龄为 58 岁(范围 29-85),ECOG 0-1 表现状态,40%的患者从不吸烟。大多数患者为腺癌,约一半的患者仅有一个脑转移灶,其余的患者有多发性脑转移灶。SRS 组的中位 OS 时间为 14.6 个月(95%CI,9.2-20.0),初始化疗组为 15.3 个月(95%CI,7.2-23.4)(P=0.418)。CNS 疾病进展时间无显著差异[中位数,9.4 个月(SRS)与 6.6 个月(初始化疗),P=0.248]。在初始化疗组中,脑转移症状进展更为常见(26.5%),而 SRS 组(18.4%)则无统计学意义。

结论

尽管由于提前终止,本研究的样本量比最初预期的要小,但 SRS 加化疗并不能改善寡脑转移 NSCLC 患者的 OS,与初始化疗相比。应进行更多患者的进一步研究,以确认在这组患者中单独使用初始化疗。

临床试验编号

NCT01301560。

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