III-IV 期腺癌和鳞状细胞癌中免疫检查点抑制剂的真实世界数据分析。
Real-world data analysis of immune checkpoint inhibitors in stage III-IV adenocarcinoma and squamous cell carcinoma.
机构信息
Department of Pulmonary and Critical Care Medicine, Qilu Hospital, Cheeloo College of Medicine, Shandong University, No. 107 Wenhua Xilu, Jinan, 250012, Shandong, China.
Department of Respiratory Medicine, Weihai Municipal Hospital, 70 Heping Road, Weihai, 264200, Shandong, China.
出版信息
BMC Cancer. 2022 Jul 13;22(1):762. doi: 10.1186/s12885-022-09843-3.
BACKGROUND
This study was designed to investigate the clinical application, efficacy, and safety of immune checkpoint inhibitors (ICIs) in the treatment of lung cancer in the real world.
METHODS
A retrospective, observational analysis was conducted on patients treated with ICIs in four tertiary hospitals in the region from January 2015 to March 2021, to evaluate the clinical efficacy of ICIs single-agent or combined chemotherapy and anti-vascular drugs in the first-line or second-line treatment of patients with lung cancer.
RESULTS
Three hundred and fifteen patients were enrolled in this study. In patients with stage III-IV adenocarcinoma and Squamous cell carcinoma, the objective response rate (ORR) and disease control rate (DCR) were 35.5% (87/245) and 93.5% (229/245), respectively, the median progression-free survival (PFS) was 10.8 months, and the median overall survival (OS) was not reached. A total of 132 patients received ICIs as the first-line treatment, the median treatment cycle was 8 cycles (2-20 cycles), the short-term efficacy ORR was 38.6%, DCR was 93.9%, and the median PFS was 11.4 months. One hundred thirteen patients received ICIs treatment as second-line treatment, the median treatment cycle was five cycles (2-10 cycles), the short-term efficacy ORR was 31.9%, DCR was 92.9%, and the median PFS was 10.0 months. There were no statistically significant differences in ORR, DCR, or median PFS with ICIs as the first-line treatment compared with the second-line treatment(P > 0.05). The results of subgroup analysis showed that Eastern Cooperative Oncology Group performance status (ECOG PS), epidermal growth factor receptor (EGFR) mutation status, pathological type and number of treatment lines were not correlated with median PFS(P > 0.05). However, there were statistically significant differences in programmed death-ligand 1(PD-L1) expression, corticosteroid interference, and antibiotic (Abx) treatment among all groups (P < 0.05). In terms of safety, the overall incidence of adverse reactions in 315 patients was 62.5%, and the incidence of immune-related adverse events (irAEs) was 13.7%. Grade 1-2 and 3-4 incidence of adverse events were 34.9 and 27.65%, respectively. There were four patients who experienced fatal irAEs, two cases were liver damage leading to liver failure, one case was immune related pneumonia, and one case was immune related myocarditis.
CONCLUSION
In the real world, ICIs has a good effect on patients with lung cancer and significantly improves ORR and PFS.
背景
本研究旨在探讨免疫检查点抑制剂（ICIs）在肺癌治疗中的临床应用、疗效和安全性。
方法
对 2015 年 1 月至 2021 年 3 月在该地区四家三级医院接受 ICI 治疗的患者进行回顾性、观察性分析，评估 ICI 单药或联合化疗和抗血管药物在肺癌一线或二线治疗中的临床疗效。
结果
本研究共纳入 315 例患者。在 III 期和 IV 期腺癌和鳞状细胞癌患者中，客观缓解率（ORR）和疾病控制率（DCR）分别为 35.5%（87/245）和 93.5%（229/245），中位无进展生存期（PFS）为 10.8 个月，中位总生存期（OS）未达到。共有 132 例患者接受 ICI 作为一线治疗，中位治疗周期为 8 个周期（2-20 个周期），短期疗效 ORR 为 38.6%，DCR 为 93.9%，中位 PFS 为 11.4 个月。113 例患者接受 ICI 二线治疗，中位治疗周期为 5 个周期（2-10 个周期），短期疗效 ORR 为 31.9%，DCR 为 92.9%，中位 PFS 为 10.0 个月。ICI 作为一线治疗与二线治疗相比，ORR、DCR 或中位 PFS 无统计学差异（P>0.05）。亚组分析结果显示，东部肿瘤协作组表现状态（ECOG PS）、表皮生长因子受体（EGFR）突变状态、病理类型和治疗线数与中位 PFS 均无相关性（P>0.05）。然而，在所有组中，程序性死亡配体 1（PD-L1）表达、皮质类固醇干扰和抗生素（Abx）治疗均有统计学差异（P<0.05）。在安全性方面，315 例患者总体不良反应发生率为 62.5%，免疫相关不良事件（irAEs）发生率为 13.7%。不良反应发生率为 1-2 级和 3-4 级分别为 34.9%和 27.65%。有 4 例患者发生致命的 irAEs，2 例为肝损伤导致肝衰竭，1 例为免疫相关性肺炎，1 例为免疫相关性心肌炎。
结论
在真实世界中，ICI 对肺癌患者有较好的疗效，显著提高了 ORR 和 PFS。
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