Abstract：
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.
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.
摘要：
背景：Ramucirumab联合多西他赛（RD）是先前治疗过的晚期非小细胞肺癌（NSCLC）的有希望的治疗方法。然而,铂类化疗加程序性死亡-1(PD-1)阻断后其临床意义尚不清楚.
目的：在非小细胞肺癌化疗失败后，RD作为二线治疗的临床意义是什么？
方法：在这项多中心回顾性研究中，288例晚期非小细胞肺癌患者在铂类化疗加PD-1阻断后接受RDas二线治疗，包括2017年1月至2020年8月的62家日本机构。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。
结果：共纳入288例患者：222例为男性（77.1%），262人年龄<75岁（91.0%），237（82.3％）有吸烟史，269（93.4％）的表现状态（PS）为0-1。99例患者（69.1％）被归类为腺癌（AC），89例（30.9％）被归类为非AC。一线治疗中使用的PD-1阻断类型是236例（81.9%）和52例（18.1%）患者的抗PD-1抗体和抗程序性死亡配体1抗体，分别。RD的客观缓解率为28.8%(95%置信区间[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)。分别。在多变量分析中，非AC和PS2-3是无进展生存期较差的独立预后因素，而骨转移的诊断，PS2-3和非AC被确定为不良总生存率的独立预后因素。
结论：RD是接受PD-1阻断联合化学免疫疗法的晚期NSCLC患者可行的二线治疗方法。
背景：UMIN000042333.
目的：在非小细胞肺癌化疗失败后，RD作为二线治疗的临床意义是什么？
方法：在这项多中心回顾性研究中，288例晚期非小细胞肺癌患者在铂类化疗加PD-1阻断后接受RDas二线治疗，包括2017年1月至2020年8月的62家日本机构。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。
结果：共纳入288例患者：222例为男性（77.1%），262人年龄<75岁（91.0%），237（82.3％）有吸烟史，269（93.4％）的表现状态（PS）为0-1。99例患者（69.1％）被归类为腺癌（AC），89例（30.9％）被归类为非AC。一线治疗中使用的PD-1阻断类型是236例（81.9%）和52例（18.1%）患者的抗PD-1抗体和抗程序性死亡配体1抗体，分别。RD的客观缓解率为28.8%(95%置信区间[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)。分别。在多变量分析中，非AC和PS2-3是无进展生存期较差的独立预后因素，而骨转移的诊断，PS2-3和非AC被确定为不良总生存率的独立预后因素。
结论：RD是接受PD-1阻断联合化学免疫疗法的晚期NSCLC患者可行的二线治疗方法。
背景：UMIN000042333.
