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种族和方案对紫杉醇和铂类联合治疗晚期非小细胞肺癌患者疗效和安全性的影响。

The impacts of race and regimens on the efficacy and safety of paclitaxel and platinum combination treatment for patients with advanced non-small cell lung cancer.

机构信息

Center for Drug Clinical Evaluation, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Eur J Clin Pharmacol. 2021 May;77(5):685-695. doi: 10.1007/s00228-021-03129-6. Epub 2021 Mar 29.

Abstract

PURPOSE

Paclitaxel-platinum chemotherapy is the first-line treatment for advanced non-small cell lung cancer (NSCLC) patients. This study quantitatively evaluated the factors influencing the efficacy and safety of the paclitaxel-platinum regimen to provide the necessary reference for the development of clinical practice and clinical trials.

METHODS

A literature search was performed using public databases. The parametric survival function was used to analyze the overall survival (OS) time course of patients treated with the paclitaxel-platinum regimen. The random effects model in the single-arm meta-analysis was used to analyze the objective response rate (ORR) and the incidence of grade 3-4 adverse events (AEs) under the predefined subgroups according to race and the regimen.

RESULTS

A total of 31 studies consisting of 3365 participants were included in the analysis. Race was the most important determinant of efficacy and safety in the paclitaxel-platinum regimen, with the median survival time and ORR in East Asians and non-East Asians being 12.2 months (95% CI: 10.5-14.4 months) and 37% (95% CI: 32-41%) and 8.4 months (95% CI: 6.5-11.0 months) and 28% (95% CI: 25-32%), respectively. The incidence of grade 3-4 AEs such as leukopenia and neutropenia was about three times higher in East Asians compared to non-East Asians.

CONCLUSIONS

The efficacy and safety of the paclitaxel-platinum regimen can vary between East Asian and non-East Asian populations and between different treatment schedules. The results of this study can provide a reliable and precise external control for the future evaluation of new treatment options for advanced NSCLC.

摘要

目的

紫杉醇-铂类化疗是晚期非小细胞肺癌(NSCLC)患者的一线治疗方案。本研究定量评估了紫杉醇-铂类方案疗效和安全性的影响因素,为临床实践和临床试验的发展提供了必要的参考。

方法

通过公共数据库进行文献检索。使用参数生存函数分析接受紫杉醇-铂类方案治疗的患者的总生存(OS)时间过程。根据种族和方案,在预定亚组中使用单臂荟萃分析的随机效应模型分析客观缓解率(ORR)和 3-4 级不良事件(AE)的发生率。

结果

共有 31 项研究,包括 3365 名参与者,纳入分析。种族是紫杉醇-铂类方案疗效和安全性的最重要决定因素,东亚人和非东亚人的中位生存时间和 ORR 分别为 12.2 个月(95%CI:10.5-14.4 个月)和 37%(95%CI:32-41%)和 8.4 个月(95%CI:6.5-11.0 个月)和 28%(95%CI:25-32%)。东亚人白细胞减少和中性粒细胞减少等 3-4 级 AE 的发生率比非东亚人高约 3 倍。

结论

紫杉醇-铂类方案的疗效和安全性在东亚人和非东亚人群以及不同治疗方案之间可能存在差异。本研究结果可为未来评估晚期 NSCLC 的新治疗方案提供可靠、精确的外部对照。

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