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. 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, p = 0.0260). However, there were no significant differences in patients who withdrew due to treatment-related adverse events from different groups. (Z = 0.0508, p = 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, p = 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.
Highlights
Distinct from other diseases, as cancer progresses, both the symptoms and treatments evolve, resulting in a complex, time-dependent relationship
Immunosuppression of immunotherapy is similar to chemotherapy, and there were no significant differences in the incidence of pneumonia, cough, dyspnea, and fever (Table 2 and Appendix 1)
There were no significant differences in patients who withdrew due to treatment-related adverse events from different groups (Z = 0:0508, p = 0:8217)
Summary
Distinct from other diseases, as cancer progresses, both the symptoms and treatments evolve, resulting in a complex, time-dependent relationship. 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. The treatment methods of lung cancer in China are surgery, chemotherapy, radiotherapy, and molecular targeted therapy mainly before 2019 [4]. In oncology clinical trial, cancer patients receiving immunosuppressive therapy such as chemotherapy and radiotherapy were more likely to develop treatment-related adverse events could impact on the dose adjustment and treatment outcome and even can lead to death in severe cases [7]. Adverse events caused by cancer immunotherapy may be a competing risk for survival endpoints, which have not been thoroughly studied
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