A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer
A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer
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DOI：
10.1093/annonc/mdu584
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发表时间：
2015-04-01
影响因子：
50.5
通讯作者：
Ahn, M. -J.
中科院分区：
文献类型：
--
作者：
Lim, S. H.;Lee, J. Y.;Ahn, M. -J.
背景资料：目前还不清楚是否治疗脑转移开始全身化疗前可以提高生存率相比，前期化疗非小细胞肺癌（NSCLC）与无症状的脑寡转移Patients and methods：我们进行了一项随机对照试验的105例患者1至4个脑转移瘤，承认三星医疗中心2008年和2013年之间。患者被随机分配接受立体定向放射外科手术（SRS）（49例患者），随后化疗或前期化疗（49例患者）。主要终点是总生存率（OS）和次要终点包括中枢神经系统（CNS）无进展生存，进展为症状性脑转移和脑功能outcome.Results：中位年龄为58岁（范围，29-85）与ECOG 0-1性能状态，和40%的患者从不吸烟。大多数患者为腺癌，约一半的患者只有一个脑转移，而其余的患者有多个脑转移。SRS组的中位OS时间为14.6个月[95%置信区间（CI），9.2-20.0]，前期化疗组为15.3个月（95% CI，7.2-23.4）（P = 0.418）。至CNS疾病进展的时间无显著差异[中位数，9.4个月（SRS）vs 6.6个月（前期化疗），P = 0.248]。脑转移瘤的症状进展更频繁地观察到在前期化疗组（26.5%）比SRS组（18.4%），但没有统计学意义conclusion.Conclusions：虽然这项研究包括较小的样本量比最初预期的提前终止，SRS化疗后并没有改善OS在寡脑转移NSCLC患者相比，前期化疗。需要对大量患者进行进一步研究，以确认在该亚组患者中单独使用前期化疗。
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.