完成 Pembrolizumab 治疗晚期非小细胞肺癌--两年治疗后的真实结果 (COPILOT)

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
Andrew Fantoni , Lydia Warburton , Benjamin Solomon , Marliese Alexander , Meghana Maddula , Lauren Julia Brown , Ines Pires da Silva , Adnan Nagrial , Farah Abu Al-Hial , Malinda Itchins , Nick Pavlakis , Samantha Bowyer
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引用次数: 0

摘要

背景使用pembrolizumab一线治疗转移性非小细胞肺癌(NSCLC)的临床试验规定最长治疗时间为两年。我们描述了一个澳大利亚多站点队列中完成两年 pembrolizumab 治疗的患者的实际疗效。方法从澳大利亚全国肿瘤登记和生物数据库(AURORA)中收集回顾性数据。主要终点为停用 pembrolizumab 后的进展率和无进展生存期 (PFS)。在使用 pembrolizumab 期间,允许对少进展性疾病进行局部治疗。结果 共确定了来自 6 个中心的 71 名患者,中位年龄为 66.0 岁,49% 为男性,90% ECOG ≤ 1。患者为白种人(82%)或亚裔(16%);过去(66%)或现在(24%)吸烟,平均吸烟37包年。组织学检查结果显示,73%为腺癌,16%为鳞癌。18名患者(25%)在确诊时已出现脑转移。中位PD-L1肿瘤比例评分(TPS)为68%;12名患者(17%)TPS为1%,43名患者(61%)TPS≥50%。没有患者出现表皮生长因子受体/ALK/ROS1改变;29/49 例患者(60%)出现 KRAS 突变。客观反应率为 78.6%。中位 PFS 为 46.1 个月(95% CI 39.5-NR),PD-L1 TPS ≥ 1% 的患者未达到(46.1-NR),而 TPS < 1% 的患者为 28.1 个月(16.3-NR)(P = .013)。17名患者(24%)因寡核苷酸进展接受了额外的局部治疗。停用 pembrolizumab 后,20 名患者(28%)出现疾病进展。TPS<1%(OR 3.46,P = .06)、无完全应答(OR 5.06,P = .04)和接受寡进展治疗(OR 3.11,P = .05)的患者病情进展率较高。结论澳大利亚队列中的NSCLC患者在完成两年的pembrolizumab治疗后,KRAS突变率和PD-L1表达率都很高;一部分患者出现脑转移和治疗后寡进展。在PD-L1 TPS <1%和没有完全应答的患者中,使用pembrolizumab后病情进展的比例较高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Completion of Pembrolizumab in Advanced Non-Small Cell Lung Cancer—Real World Outcomes After Two Years of Therapy (COPILOT)

Background

Seminal trials with first-line pembrolizumab for metastatic non-small cell lung cancer (NSCLC) mandated a maximum two-years treatment. We describe real-world outcomes of a multi-site Australian cohort of patients who completed two-years of pembrolizumab.

Methods

Retrospective data were collected from the national AUstralian Registry and biObank of thoRacic cAncers (AURORA). Primary endpoints were progression rate post pembrolizumab discontinuation; and progression free survival (PFS). Local treatment of oligoprogressive disease during pembrolizumab was allowed.

Results

A total of 71 patients from six centers, median age 66.0 years, 49% male and 90% ECOG ≤ 1 were identified. Patients were Caucasian (82%) or Asian (16%); past (66%) or current (24%) smokers with mean 37 pack-years. Histology comprised 73% adenocarcinoma and 16% squamous. 18 patients (25%) had brain metastases at diagnosis. Median PD-L1 tumor proportion score (TPS) was 68%; 12 patients (17%) TPS < 1% and 43 (61%) TPS ≥ 50%. No patients had EGFR/ALK/ROS1 alterations; 29/49 tested (60%) had KRAS mutations.

Median follow up was 38.7 months. Objective response rate 78.6%. Median PFS 46.1 months (95% CI 39.5-NR), not reached (46.1-NR) in PD-L1 TPS ≥ 1% versus 28.1 months (16.3-NR) in TPS < 1% (P = .013). 17 patients (24%) received additional local therapy for oligoprogression. Post pembrolizumab discontinuation, 20 patients (28%) had disease progression. Higher rates of progression occurred with TPS < 1% (OR 3.46, P = .06), without complete response (OR 5.06, P = .04), and with treated oligoprogression (OR 3.11, P = .05). 36-month landmark survival was 98.2%.

Conclusion

Patients completing two-years of pembrolizumab for NSCLC in an Australian cohort had high rates of KRAS mutation and PD-L1 expression; a proportion had brain metastases and treated oligoprogression. Progression post pembrolizumab was higher in PD-L1 TPS < 1% and in those without complete response.

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CiteScore
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自引率
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