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. Material and Methods. 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, ). However, there were no significant differences in patients who withdrew due to treatment-related adverse events from different groups. (, ). 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, ), 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.

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通过纳入竞争风险因素改善肺癌临床试验开发

简介。与其他疾病不同的是，随着癌症的进展，症状和治疗都会发生变化，从而产生复杂的、时间依赖性的关系。许多相互竞争的风险因素会影响癌症的结果。采用改进的方法评估自 2016 年以来在我们中心合并的 6 项非小细胞肺癌 (NSCLC) 临床试验的数据，以应对竞争风险因素造成的偏倚。材料和方法。收集 2016 年至 2020 年 118 例肺癌患者的数据。采用 Fine 和 Gray 竞争风险模型与经典生存分析模型比较不同治疗组的生存率。结果。免疫疗法比化疗具有更好的无进展生存期。(HR: 0.62, 95% CI: 0.41-0.95,）。然而，不同组因治疗相关不良事件而退出的患者没有显着差异。(, ）。与化疗相比，我们研究中的 PD-1/PD-L1 抑制剂并未显着提高总生存期（HR：0.77，95% CI：0.48-1.24，)，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消除经典生存分析造成的偏差。