Completion of Pembrolizumab in Advanced Non-Small Cell Lung Cancer—Real World Outcomes After Two Years of Therapy (COPILOT)

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical lung cancer Pub Date : 2024-07-01 DOI:10.1016/j.cllc.2024.04.008

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

Abstract

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

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。

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来源期刊

Clinical lung cancer 医学-肿瘤学

CiteScore

7.00

自引率

2.80%

发文量

159

审稿时长

24 days

期刊介绍： Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.