Lackovic Lora Novakovic, Tomic Milica Srecic, Novakovic Marko, Turic Mirko, Kajkut Aleksandra, Macinkovic Teodora, Stanetic Mirko, Glamocak Ranko
Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
Clinic for Pulmonary Diseases of the University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina.
Front Med (Lausanne). 2025 Sep 1;12:1635626. doi: 10.3389/fmed.2025.1635626. eCollection 2025.
Immune checkpoint inhibitors (ICIs) have become the standard first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) without targetable mutations. This study aimed to assess real-world outcomes of pembrolizumab monotherapy in patients with high PD-L1 expression (≥50%) and compare them with results from the KEYNOTE-024 clinical trial.
This retrospective study included patients with advanced or metastatic NSCLC treated with pembrolizumab as first-line therapy at the Clinic for Pulmonary Diseases, University Clinical Center of Republika Srpska, between January 2018 and December 2022. Clinical and pathological data were collected from medical records and analyzed using descriptive and inferential statistical methods.
The cohort included 46 patients with a median age of 64 years; 56.5% were aged ≥65, 73.9% were male, 76% were smokers, and 72% had an ECOG performance status of 1. Adenocarcinoma (AC) and squamous cell carcinoma (SCC) were diagnosed in 50 and 46% of cases, respectively, while 70% had metastatic disease and 15% had brain metastases. The two-year objective response rate (ORR) was 72.2%, lower than the 85.7% reported in KEYNOTE-024, possibly due to differences in PD-L1 assay (SP263 vs. 22C3) and patient selection. Despite this, the median overall survival (OS) was 36 months-higher than in the trial. One-, two-, and three-year survival rates were 57.9, 53.5, and 42.8%, respectively.
Our findings confirm the clinical benefit of pembrolizumab in a real-world setting, despite lower ORR compared to clinical trial data. However, the prognosis remains guarded due to the advanced stage and comorbidities of the population. Further investigation is warranted to optimize patient selection and treatment strategies.
免疫检查点抑制剂（ICIs）已成为无可靶向突变的晚期或转移性非小细胞肺癌（NSCLC）患者的标准一线治疗方法。本研究旨在评估帕博利珠单抗单药治疗高PD-L1表达（≥50%）患者的真实世界疗效，并将其与KEYNOTE-024临床试验结果进行比较。
这项回顾性研究纳入了2018年1月至2022年12月期间在塞尔维亚共和国大学临床中心肺病诊所接受帕博利珠单抗一线治疗的晚期或转移性NSCLC患者。从医疗记录中收集临床和病理数据，并使用描述性和推断性统计方法进行分析。
该队列包括46例患者，中位年龄为64岁；56.5%的患者年龄≥65岁，73.9%为男性，76%为吸烟者，72%的患者ECOG体能状态为1。腺癌（AC）和鳞状细胞癌（SCC）分别在50%和46%的病例中被诊断出来，而70%的患者有转移性疾病，15%的患者有脑转移。两年客观缓解率（ORR）为72.2%，低于KEYNOTE-024中报告的85.7%，这可能是由于PD-L1检测方法（SP263与22C3）和患者选择的差异。尽管如此，中位总生存期（OS）为36个月，高于试验中的生存期。1年、2年和3年生存率分别为57.9%、53.5%和42.8%。
我们的研究结果证实了帕博利珠单抗在真实世界环境中的临床益处，尽管与临床试验数据相比ORR较低。然而，由于该人群的晚期阶段和合并症，预后仍然不容乐观。有必要进一步研究以优化患者选择和治疗策略。
