Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Department of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Hidaka, Japan.
Eur J Cancer. 2023 May;184:62-72. doi: 10.1016/j.ejca.2023.01.025. Epub 2023 Feb 11.
Ramucirumab plus docetaxel (RD) is a promising treatment for previously treated advanced non-small cell lung cancer (NSCLC). However, its clinical significance after platinum-based chemotherapy plus programmed death-1 (PD-1) blockade remains unclear.
What is the clinical significance of RD as a second-line treatment after the failure of chemo-immunotherapy in NSCLC?
In this multicentre retrospective study, 288 patients with advanced NSCLC who received RDas second-line therapy after platinum-based chemotherapy plus PD-1 blockade, at 62 Japanese institutions from January 2017 to August 2020, were included. Prognostic analyses were performed using the log-rank test. Prognostic factor analyses were performed using a Cox regression analysis.
A total of 288 patients were enrolled: 222 were men (77.1%), 262 were aged <75 years (91.0%), 237 (82.3%) had smoking history and 269 (93.4%) had a performance status (PS) of 0-1. One hundred ninety-nine patients (69.1%) were classified as adenocarcinoma (AC) and 89 (30.9%) as non-AC. The types of PD-1 blockade used in the first-line treatment were anti-PD-1 antibody and anti-programmed death-ligand 1 antibody in 236 (81.9%) and 52 (18.1%) patients, respectively. The objective response rate for RD was 28.8% (95% confidence interval [CI], 23.7-34.4). The disease control rate was 69.8% (95% CI, 64.1-75.0).The median progression free survival and overall survival were 4.1 months (95% CI, 3.5-4.6) and 11.6 months (95% CI, 9.9-13.9), respectively. In a multivariate analysis, non-AC and PS 2-3 were independent prognostic factors for worse progression free survival , while bone metastasis on diagnosis, PS 2-3 and non-AC were identified as independent prognostic factors for poor overall survival.
RD is a feasible second-line treatment in patients with advanced NSCLC who had received combined chemo-immunotherapy with PD-1 blockade.
UMIN000042333.
雷莫芦单抗联合多西他赛（RD）是一种有前途的治疗方案，适用于先前接受过治疗的晚期非小细胞肺癌（NSCLC）患者。然而，其在铂类化疗联合程序性死亡受体-1（PD-1）阻断后的临床意义尚不清楚。
RD 在铂类化疗加 PD-1 阻断失败后作为二线治疗在 NSCLC 中的临床意义是什么？
本研究为多中心回顾性研究，共纳入 2017 年 1 月至 2020 年 8 月期间，62 家日本机构的 288 例接受 RD 二线治疗的铂类化疗加 PD-1 阻断后晚期 NSCLC 患者。使用对数秩检验进行预后分析。使用 Cox 回归分析进行预后因素分析。
共纳入 288 例患者：男性 222 例（77.1%），年龄<75 岁 262 例（91.0%），有吸烟史 237 例（82.3%），PS 0-1 级 269 例（93.4%）。199 例（69.1%）为腺癌（AC），89 例（30.9%）为非 AC。一线治疗中使用的 PD-1 阻断剂类型分别为抗 PD-1 抗体和抗程序性死亡配体 1 抗体，分别为 236 例（81.9%）和 52 例（18.1%）。RD 的客观缓解率为 28.8%（95%可信区间[CI]，23.7-34.4）。疾病控制率为 69.8%（95%CI，64.1-75.0）。中位无进展生存期和总生存期分别为 4.1 个月（95%CI，3.5-4.6）和 11.6 个月（95%CI，9.9-13.9）。多因素分析显示，非 AC 和 PS 2-3 是无进展生存期较差的独立预后因素，而诊断时的骨转移、PS 2-3 和非 AC 是总生存期不良的独立预后因素。
RD 是 PD-1 阻断联合化疗后进展的晚期 NSCLC 患者的一种可行的二线治疗选择。
UMIN000042333。
