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通过纳入竞争风险因素来改善肺癌临床试验的开发。

Improving the Lung Cancer Clinical Trial Development by Incorporating Competing Risk Factors.

机构信息

Jiangsu Cancer Hospital, Affiliated Cancer Hospital of Nanjing Medical University, China.

出版信息

Biomed Res Int. 2021 Sep 14;2021:2477285. doi: 10.1155/2021/2477285. eCollection 2021.

DOI:10.1155/2021/2477285
PMID:34568489
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8457938/
Abstract

INTRODUCTION

Distinct from other diseases, as cancer progresses, both the symptoms and treatments evolve, resulting in a complex, time-dependent relationship. Many competing risk factors influence the outcome of cancer. An improved method was used to evaluate the data from 6 non-small-cell lung cancer (NSCLC) clinical trials combined in our center since 2016 to deal with the bias caused by competing risk factors. . Data of 118 lung cancer patients were collected from 2016 to 2020. Fine and Gray's model for competing risk was used to evaluate survival of different treatment group compares with the classic survival analysis model.

RESULTS

Immunotherapy had better progression-free survival than chemotherapy. (HR: 0.62, 95% CI: 0.41-0.95, = 0.0260). However, there were no significant differences in patients who withdrew due to treatment-related adverse events from different groups. ( = 0.0508, = 0.8217). The PD-1/PD-L1 inhibitors in our study did not significantly improve overall survival compared with chemotherapy (HR:0.77, 95% CI:0.48-1.24, = 0.2812), estimated 1-year overall survival rates were 55% and 46%, and 3-year overall survival rates were 17% and 10%, respectively.

CONCLUSION

When the outcome caused by competing risk exists, the corresponding competing risk model method should be adopted to eliminate the bias caused by the classic survival analysis.

摘要

简介

与其他疾病不同,随着癌症的进展,症状和治疗方法都在不断演变,导致了一种复杂的、随时间变化的关系。许多竞争风险因素影响着癌症的结果。我们采用了一种改进的方法来评估自 2016 年以来在我们中心联合进行的 6 项非小细胞肺癌(NSCLC)临床试验的数据,以解决竞争风险因素引起的偏差。从 2016 年到 2020 年,我们收集了 118 名肺癌患者的数据。使用 Fine 和 Gray 的竞争风险模型来评估不同治疗组的生存情况,与经典生存分析模型进行比较。

结果

免疫治疗比化疗有更好的无进展生存期。(HR:0.62,95%CI:0.41-0.95, = 0.0260)。然而,不同组因治疗相关不良反应而退出的患者之间没有显著差异。( = 0.0508, = 0.8217)。与化疗相比,我们研究中的 PD-1/PD-L1 抑制剂并没有显著提高总生存期(HR:0.77,95%CI:0.48-1.24, = 0.2812),估计 1 年总生存率分别为 55%和 46%,3 年总生存率分别为 17%和 10%。

结论

当存在竞争风险导致的结果时,应采用相应的竞争风险模型方法来消除经典生存分析引起的偏差。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/179bc2248bc8/BMRI2021-2477285.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/93795bd6f3b5/BMRI2021-2477285.001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/179bc2248bc8/BMRI2021-2477285.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/93795bd6f3b5/BMRI2021-2477285.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/58ca5ad0768e/BMRI2021-2477285.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/8bbf74cc91a2/BMRI2021-2477285.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/577acfb267ed/BMRI2021-2477285.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/564c/8457938/179bc2248bc8/BMRI2021-2477285.005.jpg

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