帕博利珠单抗治疗晚期非小细胞肺癌的评估：一项回顾性、单中心、单臂研究。
Evaluation of pembrolizumab for the treatment of advanced non-small cell lung cancer: a retrospective, single-centre, single-arm study.
作者信息
Guo Tianxing, Ding Yun, Chen Long, Zhu Lihuan, Lin Jinlan, Zhang Jiguang, Huang Yangyun, Li Wujin, Lin Rongjia, Pan Xiaojie
机构信息
Department of Thoracic Surgery, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.
Shengli Clinical Medical College of Fujian Medical University, Fuzhou, China.
出版信息
J Thorac Dis. 2021 Jan;13(1):282-290. doi: 10.21037/jtd-20-3413.
BACKGROUND
Immune checkpoint inhibitors (ICIs) provided a paradigm shift for advanced non-small cell lung cancer (NSCLC) treatment and improved the clinical prognosis of such patients. Pembrolizumab is a humanized anti-programmed death cell protein 1 (PD-1) monoclonal antibody, approved for the treatment of patients with advanced or metastatic NSCLC. This article investigated and reported on the efficacy and safety of pembrolizumab in the treatment of advanced NSCLC in our center since 2019.
METHODS
Patients with clinical stage III-IV NSCLC treated with pembrolizumab for ≥4 cycles were enrolled as participants in this study. Pembrolizumab was administered intravenously at a dose of 2 mg/kg every 3 weeks. A cycle was defined as 3 weeks of treatment. We assessed the efficacy and safety of pembrolizumab through the collection of researcher-assessed tumor response, survival, and safety data.
RESULTS
A total of 24 patients were included in this study. The median follow-up time was 9 months (3-20 months) and the median period of pembrolizumab therapy was 7 cycles (4-21 cycles). The objective response rate (ORR) was 45.8% and disease control rate (DCR) was 70.8%. The median overall survival (OS) and progression-free survival (PFS) times were not reached. A total of 2 programmed death-ligand 1 (PD-L1)-negative participants were treated with pembrolizumab combined with chemotherapy and there was no significant progression during the follow-up period. During the follow-up period, 8 patients underwent surgery. The major pathological response (MPR) was 75% and pathological complete response (pCR) was 50%. A case that was preoperatively diagnosed with clinical stage IV achieved pCR after 6 cycles of pembrolizumab combined with chemotherapy. The incidence of adverse effects (AEs) was 83.3%, and 16.7% of these were serious AEs (grade ≥3), which was similar to the incidence reported in previous studies.
CONCLUSIONS
This real-world data supports the use of pembrolizumab for advanced NSCLC, including those cases that are PD-L1 negative. More importantly, pembrolizumab immunotherapy can also provide the potential of local treatment for patients with advanced NSCLC, which has wide application prospects in the field of surgery.
背景
免疫检查点抑制剂（ICIs）为晚期非小细胞肺癌（NSCLC）的治疗带来了范式转变，并改善了此类患者的临床预后。帕博利珠单抗是一种人源化抗程序性死亡细胞蛋白1（PD-1）单克隆抗体，已被批准用于治疗晚期或转移性NSCLC患者。本文对自2019年以来帕博利珠单抗在本中心治疗晚期NSCLC的疗效和安全性进行了调查并报告。
方法
将接受帕博利珠单抗治疗≥4个周期的临床III-IV期NSCLC患者纳入本研究。帕博利珠单抗静脉给药，剂量为2mg/kg，每3周一次。一个周期定义为3周的治疗时间。我们通过收集研究者评估的肿瘤反应、生存和安全性数据来评估帕博利珠单抗的疗效和安全性。
结果
本研究共纳入24例患者。中位随访时间为9个月（3-20个月），帕博利珠单抗治疗的中位周期数为7个周期（4-21个周期）。客观缓解率（ORR）为45.8%，疾病控制率（DCR）为70.8%。中位总生存期（OS）和无进展生存期（PFS）未达到。共有2例程序性死亡配体1（PD-L1）阴性的参与者接受了帕博利珠单抗联合化疗，随访期间无明显进展。随访期间，8例患者接受了手术。主要病理缓解（MPR）为75%，病理完全缓解（pCR）为50%。1例术前诊断为临床IV期的患者在接受6个周期的帕博利珠单抗联合化疗后达到pCR。不良反应（AE）的发生率为83.3%，其中16.7%为严重AE（≥3级），这与既往研究报道的发生率相似。
结论
这些真实世界的数据支持帕博利珠单抗用于晚期NSCLC，包括那些PD-L1阴性的病例。更重要的是，帕博利珠单抗免疫治疗还可为晚期NSCLC患者提供局部治疗的潜力，在外科领域具有广阔的应用前景。
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