二线阿法替尼对比化疗治疗免疫治疗初治的晚期肺鳞癌的真实世界疗效。

Real-world effectiveness of second-line Afatinib versus chemotherapy for the treatment of advanced lung squamous cell carcinoma in immunotherapy-naïve patients.

机构信息

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Taiwan University Hospital Yunlin Branch, Yunlin Count, Douliu City, Taiwan, Republic of China.

College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

BMC Cancer. 2021 Nov 15;21(1):1225. doi: 10.1186/s12885-021-08920-3.

DOI:10.1186/s12885-021-08920-3

PMID:34781919

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8594240/

Abstract

BACKGROUND

Limited treatment options exist for relapsed advanced lung squamous cell carcinoma (SCC), leading to poor outcomes compared with adenocarcinoma. This study aimed to investigate the efficacy of second-line afatinib versus chemotherapy in patients with advanced lung SCC who progressed after first-line chemotherapy.

METHODS

In this retrospective, multisite cohort study, we recruited patients with initial locally advanced or metastatic lung SCC from four institutes in Taiwan between June 2014 and October 2020. The primary endpoint of this study was progression-free survival (PFS), and the secondary endpoints were the objective response rate (ORR), disease control rate (DCR), and overall survival (OS).

RESULTS

The present study enrolled 108 patients: 19 received second-line afatinib, and 89 received second-line chemotherapy. The median ages were 71 and 67 years, respectively. PFS was significantly longer among patients who received afatinib than among those who received chemotherapy (median 4.7 months [95% confidence interval (CI), 0.1-7.5] vs. 2.6 months [95% CI, 0.9-6.7]; hazard ratio (HR) 0.53 [95% CI 0.32-0.88], p = 0.013). Compared with the chemotherapy group, OS was longer in the afatinib group but did not reach significance (median 16.0 months [95% CI, 6.1-22.0] vs. 12.3 months [6.2-33.9]; HR 0.65 [95% CI 0.38-1.11], p = 0.112).

CONCLUSIONS

Afatinib offered a longer PFS and comparable OS to chemotherapy in advanced lung SCC patients in a real-world setting, it may be considered as a 2nd line alternative treatment choice for immunotherapy unfit advanced lung SCC patients.

摘要

背景

与腺癌相比，复发的晚期肺鳞状细胞癌（SCC）的治疗选择有限，导致预后较差。本研究旨在探讨二线阿法替尼与化疗在一线化疗后进展的晚期肺 SCC 患者中的疗效。

方法

在这项回顾性、多中心队列研究中，我们从台湾的四家机构招募了 2014 年 6 月至 2020 年 10 月期间初治局部晚期或转移性肺 SCC 的患者。本研究的主要终点是无进展生存期（PFS），次要终点是客观缓解率（ORR）、疾病控制率（DCR）和总生存期（OS）。

结果

本研究纳入了 108 例患者：19 例接受二线阿法替尼治疗，89 例接受二线化疗。中位年龄分别为 71 岁和 67 岁。接受阿法替尼治疗的患者的 PFS 明显长于接受化疗的患者（中位 PFS 4.7 个月[95%CI 0.1-7.5] vs. 2.6 个月[95%CI 0.9-6.7]；风险比（HR）0.53[95%CI 0.32-0.88]，p=0.013）。与化疗组相比，阿法替尼组的 OS 更长，但无统计学意义（中位 OS 16.0 个月[95%CI 6.1-22.0] vs. 12.3 个月[6.2-33.9]；HR 0.65[95%CI 0.38-1.11]，p=0.112）。