Department of Oncology, University Medical Centre Maribor, Maribor, Slovenia.
University Clinic Golnik, Golnik, Slovenia.
Oncologist. 2021 Dec;26(12):e2143-e2150. doi: 10.1002/onco.13909. Epub 2021 Aug 2.
Immunotherapy with immune checkpoint inhibitors (ICIs) recently became the standard treatment for patients with advanced non-small cell lung cancer (NSCLC). Here, we present the first results of a real-world observational study on the effectiveness of ICI monotherapy in patients with advanced NSCLC treated at a single academic center in a Central and Eastern European (CEE) country.
Overall, 66 consecutive patients with advanced NSCLC treated with ICIs in everyday clinical practice, either with first-line pembrolizumab (26 patients) or second-line atezolizumab, nivolumab, or pembrolizumab (40 patients), from August 2015 to November 2018, were included. All data were retrieved from a hospital lung cancer registry, in which the data is collected prospectively.
Included patients had a median age of 64 years, most were male (55%), 6% were in performance status ≥2, and 18% had controlled central nervous system metastases at baseline. In first-line, the median progression-free survival (mPFS) was 9.3 months, while the median overall survival (mOS) was not reached. The 1-year overall survival (OS) was 62%. In second-line, the mPFS and mOS were 3.5 months and 9.9 months, respectively, with a 1-year OS of 35%. In the overall population, adverse events of any grade were recorded in 79% of patients and of severe grade (3-4) in 12% of patients.
The first real-world outcomes of NSCLC immunotherapy from a CEE country suggest comparable effectiveness to those observed in clinical trials and other real-world series, mainly coming from North America and Western European countries. Further data to inform on the real-world effectiveness of immunotherapy worldwide are needed.
Immunotherapy is a standard treatment of advanced non-small cell lung cancer (NSCLC). The real-world data on immunotherapy are still limited. This article presents the first data on the effectiveness of mono-immunotherapy with immune checkpoint inhibitors for patients with advanced NSCLC treated at a single academic center in a Central and Eastern European country. The survival rates and toxicity are comparable to those achieved in randomized clinical trials and other real-world series, coming mainly from North American and Western European countries. There is a pressing need to gather further data on the effectiveness of immunotherapy in everyday practice worldwide.
免疫检查点抑制剂（ICI）的免疫疗法最近已成为晚期非小细胞肺癌（NSCLC）患者的标准治疗方法。在这里，我们首次报告了在中东欧（CEE）国家的一家学术中心接受治疗的晚期 NSCLC 患者接受 ICI 单药治疗的真实观察研究的结果。
总体而言，共纳入了 2015 年 8 月至 2018 年 11 月在日常临床实践中接受 ICI 治疗的 66 例接受先进 NSCLC 的连续患者，其中包括一线治疗的 pembrolizumab（26 例）或二线治疗的 atezolizumab、nivolumab 或 pembrolizumab（40 例）。所有数据均从医院肺癌登记处检索，该数据是前瞻性收集的。
纳入的患者中位年龄为 64 岁，大多数为男性（55％），体能状态≥2 的患者占 6％，基线时有 18％的患者中枢神经系统转移得到控制。一线治疗中，中位无进展生存期（mPFS）为 9.3 个月，而中位总生存期（mOS）尚未达到。1 年总生存率（OS）为 62％。二线治疗中，mPFS 和 mOS 分别为 3.5 个月和 9.9 个月，1 年 OS 率为 35％。在总体人群中，任何级别的不良事件发生率为 79％，严重程度为 3-4 级的发生率为 12％。
来自 CEE 国家的 NSCLC 免疫治疗的首批真实世界结果表明，其有效性与临床试验和其他真实世界系列观察到的结果相当，主要来自北美和西欧国家。需要进一步的数据来告知全球免疫治疗的真实世界疗效。
免疫治疗是晚期非小细胞肺癌（NSCLC）的标准治疗方法。免疫治疗的真实世界数据仍然有限。本文首次介绍了在中东欧国家的一家学术中心接受治疗的晚期 NSCLC 患者接受单药免疫检查点抑制剂治疗的有效性数据。生存率和毒性与随机临床试验和其他主要来自北美和西欧国家的真实世界系列观察到的结果相当。迫切需要在全球范围内收集更多关于免疫治疗在日常实践中的有效性的数据。
