辛替单抗联合化疗治疗晚期非小细胞肺癌疗效和安全性的meta分析

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental Pub Date : 2025-01-01 DOI:10.1016/j.curtheres.2025.100796

Liling Pan MPharm , Qiongqing Chen MPharm , Ningsheng Liang PhD , Jinying Liang MBBS , Youjia Guo MMed

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引用次数: 0

摘要

目的：intilimab是一种创新的免疫检查点抑制剂（ICI），在中国国内生产，在治疗肺癌方面表现出显著的疗效。然而，由于ICI在中国的开发起步较晚，其使用目前仅限于国内市场，导致临床数据量有限，这给上市后评价带来了挑战。本研究旨在通过荟萃分析评估辛替单抗的安全性和有效性。方法分别在国内外数据库中独立检索相关文献，进行独立筛选，并从所选研究中提取数据。采用RevMan 5.4版软件进行统计分析，采用95%置信区间的风险比对结果进行估计。结果疗效分析显示，辛替单抗联合化疗可显著提高非小细胞肺癌（NSCLC）患者的客观有效率和疾病控制率，同时降低疾病进展风险。对辛替单抗的安全性评价显示，晚期NSCLC患者治疗后发生甲状腺功能减退、肺炎和皮疹的风险分别比对照组高3.70倍、2.22倍和1.58倍。联合治疗组与化疗组在血液系统毒性、肝功能损害和发热发生率方面无显著差异；然而，在联合治疗组中，恶心、呕吐和腹泻似乎不那么严重。结论辛替单抗联合化疗治疗晚期非小细胞肺癌疗效良好；然而，必须密切监测不良事件，特别是与免疫有关的不良事件。临床试验注册不可用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Meta-Analysis of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy for Advanced Non–Small-Cell Lung Cancer

Objective

Sintilimab is an innovative immune checkpoint inhibitor (ICI), domestically produced in China, that exhibits significant efficacy in the treatment of lung cancer. However, due to the delayed initiation of ICI development in China, its use is currently restricted to domestic markets, resulting in a limited volume of clinical data, which poses a challenge in postmarketing evaluation. This study aimed to assess the safety and efficacy of sintilimab through a meta-analysis.

Methods

We conducted independent searches for relevant articles in both Chinese and international databases, followed by independent screening, after which the data were extracted from the selected studies. Statistical analysis was performed using RevMan software, version 5.4, and the results were estimated using the risk ratio with 95% confidence interval.

Results

Efficacy analysis revealed that sintilimab, when combined with chemotherapy, significantly enhanced the objective response rate and disease control rate in patients with non-small-cell lung cancer (NSCLC) while reducing the risk of disease progression. Evaluation of the safety of sintilimab revealed that the risks of hypothyroidism, pneumonia, and rash in patients with advanced NSCLC following treatment were higher than those of the control group by 3.70-fold, 2.22-fold, and 1.58-fold, respectively. There were no significant differences between the combination therapy and chemotherapy groups in terms of the incidence of blood system toxicity, impairment of liver function, and fever; however, nausea, vomiting, and diarrhea appeared to be less severe in the combination therapy group.

Conclusions

Sintilimab, combined with chemotherapy, demonstrates promising efficacy in the treatment of advanced NSCLC; however, it is imperative to closely monitor for adverse events, particularly immune-related adverse events.

Clinical trial registration

Not available.

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来源期刊

Current Therapeutic Research-clinical and Experimental 医学-药学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

3 months

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