SCI
4 August 2019
Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non–Small Cell Lung Cancer
Bauml JM, Mick R, Ciunci C, et al. Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer: A Phase 2 Trial. JAMA Oncol 2019.
Corresponding Author: Joshua M.Bauml, MD, Abramson Cancer Center, Perelman Center for Advanced Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10th Floor, Philadelphia, PA 19104 (joshua.bauml@pennmedicine.upenn.edu).
IMPORTANCE 重要性
Patients 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.
寡转移性非小细胞肺癌（NSCLC）患者可能受益于局部消融治疗（LAT），如手术或立体定向放射治疗。之前的研究是在免疫治疗出现之前进行的，使用免疫疗法的一个强有力的生物学原理存在于一个极小的残留疾病状态中。
OBJECTIVE 目的
To evaluate whether the addition of pembrolizumab after LAT improves outcomes for patients with oligometastatic NSCLC.
评估LAT后加用pembrolizumab是否能改善寡转移性NSCLC患者的预后。
DESIGN, SETTING, AND PARTICIPANTS 设计、设置与参与者
This 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 (≤4metastatic sites) and had completed LAT to all known sites of disease. Data were analyzed from February 1, 2015, to August 23, 2018.
这项针对pembrolizumab治疗的单臂2期试验于2015年2月1日至2017年9月30日在学术转诊癌症中心进行。入选的51名符合条件的患者具有寡转移性NSCLC（≤4转移部位）并且已经完成了对所有已知疾病部位的LAT。数据分析自2015年2月1日至2018年8月23日。
INTERVENTIONS 干预
Within 4 to 12 weeks of completing LAT, patients began intravenous pembrolizumab therapy, 200mg every 21 days, for 8 cycles, with provision to continue to 16 cycles in the absence of progressive disease or untoward toxic effects.
在完成LAT的4至12周内，患者开始静脉注射pembrolizumab治疗，每21天注射200mg，持续8个周期，在没有进展性疾病或不良毒性作用的情况下持续到16个周期。
MAIN OUTCOMES AND MEASURES 主要结果与方法
The 2 primary efficacy end points were progression-free survival (PFS) from the start of LAT (PFS-L), which preceded enrollment in the trial, and PFS from the start of pembrolizumab therapy (PFS-P). The study was powered for comparison with historical data on the first efficacy end point. Secondary outcomes included overall survival, safety, and quality of life as measured by the Functional Assessment of Cancer Therapy–Lung instrument.
2个主要疗效终点是在入组试验之前，从LAT开始（PFS-L）开始的无进展生存期（PFS），以及从pembrolizumab治疗开始时的PFS（PFS-P）。本研究有助于与第一个疗效终点的历史数据进行比较。次要结果包括通过癌症治疗功能评估—肺部仪器测量的总体生存率，安全性和生活质量。
RESULTS 结果
Of 51 patients enrolled, 45 (24 men [53%]; median age, 64 years [range, 46-82 years]) received pembrolizumab. At the time of analysis, 24 patients had progressive disease or had died. Median PFS-L was 19.1 months (95%CI, 9.4-28.7 months), significantly greater than the historical median of 6.6 months (P = .005). Median PFS-P was 18.7 months (95%CI, 10.1-27.1 months). Eleven patients died. Overall mean (SE) survival rate at 12 months was 90.9% (4.3%); at 24 months, 77.5% (6.7%). Neither programmed death ligand 1 expression nor CD8 T-cell tumor infiltration was associated with PFS-L. Pembrolizumab after LAT yielded no new safety signals and no reduction in quality of life.
在组选的51名患者中，45名（24名男性[53％];中位年龄，64岁[范围，46-82岁]）接受了pembrolizumab。在分析时，24名患者患有进展性疾病或已经死亡。PFS-L中位数为19.1个月（95％CI，9.4-28.7个月），显著高于6.6个月的历史中位数（P = .005）。PFS-P中位数为18.7个月（95％CI，10.1-27.1个月）。11名患者死亡。12个月时的总体平均（SE）存活率为90.9％（4.3％）; 24个月，77.5％（6.7％）。程序性死亡配体1表达和CD8 T细胞肿瘤浸润均与PFS-L无关。在LAT后的Pembrolizumab没有产生新的安全性信号，也没有降低生活质量。
CONCLUSIONS AND RELEVANCE 结论与意义
Pembrolizumab after LAT for oligometastatic NSCLC appears to improve PFS with no reduction in quality of life.
对于低转移NSCLC，经LAT治疗后的pembrolizumab似乎可以改善PFS，而不会降低生活质量。
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