尼达尼布联合多西他赛治疗既往治疗的肺非鳞非小细胞肺癌患者的疗效和安全性：一项多中心回顾性真实世界分析。
Efficacy and safety of nintedanib and docetaxel in patients with previously treated lung non-squamous non-small cell lung cancer: a multicenter retrospective real-world analysis.
机构信息
Department for Respiratory Diseases Jordanovac, University Hospital Centre Zagreb, Zagreb, Croatia.
Medical Oncology Unit, University Clinic Golnik, Golnik, Slovenia.
出版信息
Radiol Oncol. 2023 Sep 4;57(3):397-404. doi: 10.2478/raon-2023-0040. eCollection 2023 Sep 1.
BACKGROUND
The standard first-line systemic treatment for patients with non-oncogene addicted advanced nonsquamous non-small cell lung cancer (NSCLC) is immunotherapy with immune checkpoint inhibitors (ICI) and/or chemotherapy (ChT). Therapy after failing ICI +/- ChT remains an open question, and docetaxel plus nintedanib represent a valid second line option.
PATIENTS AND METHODS
A multicenter retrospective trial of real-life treatment patterns and outcomes of patients with advanced lung adenocarcinoma treated with docetaxel plus nintedanib after the failure of ICI and/or ChT was performed. Patients from 2 Slovenian and 1 Croatian oncological center treated between June 2014 and August 2022 were enrolled. We assessed objective response (ORR), disease control rate (DCR), median progression free survival (PFS), median overall survival (OS), and safety profile of treatment.
RESULTS
There were 96 patients included in the analysis, with ORR of 18.8%, DCR of 57.3%, median PFS of 3.0 months (95% CI: 3.0-5.0 months), and a median OS of 8.0 months (95% CI: 7.0-10.0 months). The majority of patients (n = 47,49%) received docetaxel plus nintedanib as third-line therapy. The ORR for this subset of patients was 19.1%, with a DCR of 57.4%. The highest response rate was observed in patients who received second-line docetaxel plus nintedanib after first-line combination of ChT-ICI therapy (n = 24), with an ORR of 29.2% and DCR of 66.7% and median PFS of 4.0 months (95% CI: 3.0-8.0 months). Fifty-three patients (55.2%) experienced adverse events (AEs), most frequently gastrointestinal; diarrhea (n = 29, 30.2%), and increased liver enzyme levels (n = 17, 17.7%).
CONCLUSIONS
The combination of docetaxel and nintedanib can be considered an effective therapy option with an acceptable toxicity profile for patients with advanced NSCLC after the failure of ICI +/- ChT.
背景
对于非成瘾性晚期非小细胞肺癌（NSCLC）患者，标准的一线全身治疗是免疫检查点抑制剂（ICI）和/或化疗（ChT）的免疫治疗。ICI +/- ChT 治疗失败后的治疗仍然是一个悬而未决的问题，多西他赛加尼达尼布是一种有效的二线选择。
患者和方法
对 2 个斯洛文尼亚和 1 个克罗地亚肿瘤中心的 96 例接受 ICI 和/或 ChT 治疗失败后接受多西他赛加尼达尼布治疗的晚期肺腺癌患者的真实治疗模式和结果进行了回顾性多中心研究。患者来自于 2014 年 6 月至 2022 年 8 月之间接受治疗。我们评估了客观缓解率（ORR）、疾病控制率（DCR）、中位无进展生存期（PFS）、中位总生存期（OS）和治疗安全性。
结果
共有 96 例患者纳入分析，ORR 为 18.8%，DCR 为 57.3%，中位 PFS 为 3.0 个月（95%CI：3.0-5.0 个月），中位 OS 为 8.0 个月（95%CI：7.0-10.0 个月）。大多数患者（n = 47，49%）接受多西他赛加尼达尼布作为三线治疗。这部分患者的 ORR 为 19.1%，DCR 为 57.4%。二线接受多西他赛加尼达尼布治疗的患者中，观察到最高的反应率，ORR 为 29.2%，DCR 为 66.7%，中位 PFS 为 4.0 个月（95%CI：3.0-8.0 个月）。53 例（55.2%）患者发生不良事件（AE），最常见的为胃肠道AE；腹泻（n = 29，30.2%）和肝酶水平升高（n = 17，17.7%）。
结论
多西他赛加尼达尼布联合治疗对于 ICI +/- ChT 治疗失败的晚期 NSCLC 患者，是一种有效的治疗选择，具有可接受的毒性特征。
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