Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial
Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial
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DOI：
10.1001/jamaoncol.2019.1449
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发表时间：
2019-09-01
期刊：
影响因子：
28.4
通讯作者：
Langer, Corey J.
中科院分区：
文献类型：
--
作者：
Bauml, Joshua M.;Mick, Rosemarie;Langer, Corey J.
关键点：与历史数据相比，在寡转移性非小细胞肺癌局部消融治疗后添加帕博利珠单抗是否改善了结局？在这项2期单臂研究中，包括45例在完成局部消融治疗后接受pembrolizumab治疗的寡转移性非小细胞肺癌患者，中位无进展生存期为19.1个月，长于历史数据。与历史数据相比，在局部消融治疗寡转移性非小细胞肺癌后使用帕博利珠单抗与无进展生存期的临床和统计学显著改善相关，这表明这种治疗方法应该在随机临床试验中进一步评估。一项手臂研究评估了Pembrolizumab治疗寡转移性非小细胞肺癌患者局部消融治疗后的结局。小细胞肺癌（NSCLC）可能受益于局部消融治疗（LAT），如手术或立体定向放射治疗。先前的研究是在免疫疗法出现之前进行的，并且在最小残留疾病状态下存在使用免疫疗法的强有力的生物学原理。目的评价LAT后加用帕博利珠单抗是否能改善寡转移性非小细胞肺癌患者的预后。设计、设置和患者：本项pembrolizumab治疗的单臂II期试验于2015年2月1日至2017年9月30日在一家学术转诊癌症中心进行。入选的51例符合条件的患者患有寡转移性NSCLC（
Key PointsQuestionDoes the addition of pembrolizumab after locally ablative therapy in oligometastatic non-small cell lung cancer improve outcomes compared with historical data? FindingsIn this phase 2 single-arm study that included 45 patients with oligometastatic non-small cell lung cancer who received pembrolizumab after completing locally ablative therapy, the median progression-free survival was 19.1 months, which was longer than historical data. MeaningThe use of pembrolizumab after locally ablative therapy for oligometastatic non-small cell lung cancer was associated with a clinically and statistically significant improvement in progression-free survival compared with historical data, which suggests that this treatment should be further evaluated in a randomized clinical trial.This phase 2 single-arm study evaluates outcomes following pembrolizumab treatment after locally ablative therapy in patients with oligometastatic non-small cell lung cancer.ImportancePatients with oligometastatic non-small cell lung cancer (NSCLC) may benefit from locally ablative therapy (LAT) such as surgery or stereotactic radiotherapy. Prior studies were conducted before the advent of immunotherapy, and a strong biological rationale for the use of immunotherapy exists in a minimal residual disease state. ObjectiveTo evaluate whether the addition of pembrolizumab after LAT improves outcomes for patients with oligometastatic NSCLC. Design, Setting, and ParticipantsThis single-arm phase 2 trial of pembrolizumab therapy was performed from February 1, 2015, through September 30, 2017, at an academic referral cancer center. The 51 eligible patients enrolled had oligometastatic NSCLC (