意大利非小细胞肺癌纳武利尤单抗扩展使用项目总体人群和关键亚组的真实世界研究结果。

Real-life results from the overall population and key subgroups within the Italian cohort of nivolumab expanded access program in non-squamous non-small cell lung cancer.

机构信息

Medical Oncology Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano, Italy.

Lung Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.

出版信息

Eur J Cancer. 2019 Dec;123:72-80. doi: 10.1016/j.ejca.2019.09.011. Epub 2019 Oct 28.

DOI:10.1016/j.ejca.2019.09.011

PMID:31671314

Abstract

BACKGROUND

Nivolumab was the first immune checkpoint inhibitor approved for previously treated advanced non-small cell lung cancer (NSCLC). Before its introduction in the market, nivolumab was made available to NSCLC patients through an expanded access program (EAP). Here we present the Italian cohort of patients with non-squamous NSCLC enrolled in a worldwide nivolumab EAP, with subgroup analyses involving elderly patients, patients with central nervous system (CNS) metastases and patients receiving nivolumab beyond progression.

METHODS

Pretreated patients with advanced non-squamous NSCLC received nivolumab at 3 mg/kg every 2 weeks up to 24 months. Efficacy data (investigator-assessed tumour response, progression date and survival) and safety data were collected.

FINDINGS

1588 patients were treated across 153 Italian centres. Overall response rate and disease control rate were 18% and 44%, respectively; median overall survival (OS) was 11.3 months (95% CI: 10.2-12.4). Elderly patients (≥70 n = 522; ≥75 n = 232) achieved outcomes similar to the global study population; patients with CNS metastases (n = 409) had an OS of 8.6 months (95% CI: 6.4-10.8), and a 1-year OS rate of 43%. Nivolumab was administered beyond progression to 276 patients (26%), 57 of whom achieved subsequent disease control; the median OS of patients receiving nivolumab beyond progression was 16.2 months (95% CI: 14.0-18.4), while 1-year OS rate was 62%.

INTERPRETATION

To date, this is the largest clinical experience with nivolumab in a real-world setting. Our data support its use in clinical practice for pretreated non-squamous NSCLC, including patients with older age or CNS metastases.

摘要

背景

纳武利尤单抗是首个获批用于治疗既往接受治疗的晚期非小细胞肺癌（NSCLC）的免疫检查点抑制剂。在其上市之前，纳武利尤单抗通过扩大准入计划（EAP）提供给 NSCLC 患者。在此，我们报告了在全球纳武利尤单抗 EAP 中入组的非鳞状 NSCLC 意大利患者队列，其中包括亚组分析，涉及老年患者、有中枢神经系统（CNS）转移的患者和接受纳武利尤单抗治疗后进展的患者。

方法

既往接受治疗的晚期非鳞状 NSCLC 患者接受纳武利尤单抗 3mg/kg，每 2 周一次，最多 24 个月。收集疗效数据（研究者评估的肿瘤反应、进展日期和生存数据）和安全性数据。

结果

1588 名患者在 153 家意大利中心接受了治疗。总体缓解率和疾病控制率分别为 18%和 44%；中位总生存期（OS）为 11.3 个月（95%CI：10.2-12.4）。老年患者（≥70 岁，n=522；≥75 岁，n=232）的结果与全球研究人群相似；有中枢神经系统转移的患者（n=409）的 OS 为 8.6 个月（95%CI：6.4-10.8），1 年 OS 率为 43%。276 名患者（26%）在疾病进展后接受了纳武利尤单抗治疗，其中 57 名患者随后获得疾病控制；接受纳武利尤单抗治疗后进展的患者的中位 OS 为 16.2 个月（95%CI：14.0-18.4），1 年 OS 率为 62%。