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西米普利单抗治疗非小细胞肺癌患者的安全性、疗效及生活质量:一项系统评价与荟萃分析

Safety, efficacy, and quality of life with cemiplimab treatment among non-small cell lung cancer patients: a systematic review and meta-analysis.

作者信息

Mane Abhay, Yadav Rukesh

机构信息

Department of Pharmacology, University of Bedfordshire, UK.

Department of Internal Medicine, Maharajgunj Medical Campus, Tribhuvan University Institute of Medicine, Maharajgunj, Kathmandu, Nepal.

出版信息

Ann Med Surg (Lond). 2025 Apr 25;87(6):3800-3809. doi: 10.1097/MS9.0000000000003329. eCollection 2025 Jun.

Abstract

BACKGROUND

Immune checkpoint inhibitors have shown promise in treating advanced non-small cell lung cancer and have a solid safety profile. Cemiplimab can be used as monotherapy or in combination with chemotherapy for both squamous and non-squamous cancers. We opted for a systematic review and meta-analysis to find out the efficacy outcome and safety profile along with quality-of-life data of cemiplimab for advanced non-small-cell lung cancer (NSCLC).

METHODS

A rigorous search of literature on PubMed, Embase, and Google Scholar was done to find relevant published publications till December 1, 2023. Outcomes like objective response rate (ORR), overall survival (OS), progression-free survival (PFS), common side effects, and quality of life among the cemiplimab and the control group were used to conduct meta-analysis using the fixed/random effect model for combined odds ratio (OR), combined hazard ratio (HR) and mean difference at confidence interval (CI) of 95%.

RESULTS

Two randomized clinical trials EMPOWER 1 and EMPOWER 3 with 1092 advanced NSCLC patients along with their follow-up studies were included. There was significantly higher OS (HR = 0.62 [0.54, 0.70], < 0.0001) and PFS (HR = 0.54 [0.48, 0.60], < 0.0001] in the treatment group. Similarly, the combined ORR was significantly higher in the treatment group as compared to the control group (2.63 [95% CI: 2.17-3.20, ≤ 0.001]). Treatment-emergent adverse effects were not different between the groups. Finally, the quality-of-life scores between the two groups were nonsignificant.

CONCLUSION

With regard to OS, PFS, ORR, quality of life scores, and an acceptable safety profile in advanced non-small cell lung cancer, cemiplimab showed clinically relevant and statistically significant improvements making it standard of care for such patients.

摘要

背景

免疫检查点抑制剂在治疗晚期非小细胞肺癌方面已显示出前景,且具有可靠的安全性。西米普利单抗可作为单药治疗或与化疗联合用于鳞状和非鳞状癌症。我们选择进行一项系统评价和荟萃分析,以了解西米普利单抗治疗晚期非小细胞肺癌(NSCLC)的疗效结果、安全性概况以及生活质量数据。

方法

对PubMed、Embase和谷歌学术上的文献进行了严格检索,以查找截至2023年12月1日的相关已发表文献。使用固定/随机效应模型,对西米普利单抗组和对照组之间的客观缓解率(ORR)、总生存期(OS)、无进展生存期(PFS)、常见副作用和生活质量等结果进行荟萃分析,计算合并比值比(OR)、合并风险比(HR)以及95%置信区间(CI)的平均差值。

结果

纳入了两项随机临床试验EMPOWER 1和EMPOWER 3,共1092例晚期NSCLC患者及其随访研究。治疗组的OS(HR = 0.62 [0.54, 0.70],P < 0.0001)和PFS(HR = 0.54 [0.48, 0.60],P < 0.0001)显著更高。同样,治疗组的合并ORR显著高于对照组(2.63 [95% CI:2.17 - 3.20,P ≤ 0.001])。两组之间的治疗出现的不良反应无差异。最后,两组之间的生活质量评分无显著差异。

结论

在晚期非小细胞肺癌的OS、PFS、ORR、生活质量评分以及可接受的安全性方面,西米普利单抗显示出临床相关且具有统计学意义的改善,使其成为此类患者的标准治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40d5/12140711/e3095507ccc2/ms9-87-3800-g003.jpg

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