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Background <p>Programmed death-1 (PD-1) inhibitors, including tislelizumab, are used in China and other countries for the treatment of lung cancer. However, the safety profile of tislelizumab has been poorly reported in lung cancer patients based on real-world data. This study aimed to evaluate the incidence of treatment-related adverse events (trAEs) and identify associated risk factors.</p> Methods <p>A retrospective, single-center study was conducted using electronic medical records of 212 lung cancer patients treated with tislelizumab-based regimens between February 2021 and February 2023. TrAEs were assessed using the Common Terminology Criteria for Adverse Events, version 5.0. Logistic regression analysis was performed to identify risk factors for trAEs.</p> Results <p>Among 212 patients, 98.11% experienced at least one trAE, and 19.81% experienced grade 3–4 trAEs. The most commonly affected systems were hematological (91.98%), hepatobiliary (66.51%), renal (55.19%), and immune (40.57%). The most frequent trAEs included anemia (83.96%), decreased lymphocyte count (53.30%), and increased lactate dehydrogenase (47.64%). Hypothyroidism (25.47%) was the most common immune-related adverse event (irAE). Severe irAEs (grade 3–4) occurred in 1.89% of patients, leading to treatment discontinuation in 4.72%. Risk factors for myelosuppression included squamous non-small cell lung cancer (sq-NSCLC) (OR 3.21, 95% CI 1.48–6.95, <i>P = </i>0.003) and combination therapy with chemotherapy (OR 3.44, 95% CI 1.79–6.59, p &lt; 0.001). Abnormal liver function was associated with cerebrovascular disease (OR 5.38, 95% CI 1.35–21.49, <i>P = </i>0.017), elevated alanine aminotransferase (ALT) levels (OR 3.74, 95% CI 1.27–11.00, <i>P = </i>0.016), and decreased creatinine levels (OR 38.82, 95% CI 2.54–592.59, <i>P = </i>0.009). Renal dysfunction was linked to sq-NSCLC (OR 4.60, 95% CI 2.16–9.82, p &lt; 0.001), decreased eGFR (OR 4.31, 95% CI 2.19–8.48, p &lt; 0.001), and current smoking status (OR 2.75, 95% CI 1.06–7.16, <i>P = </i>0.038). Thyroid dysfunction was strongly associated with elevated thyrotropin levels (OR 8.09, 95% CI 2.11–31.02, <i>P = </i>0.002) and cardiovascular disease (OR 4.07, 95% CI 1.75–9.45, <i>P = </i>0.001). Sq-NSCLC, decreased levels of creatinine and eGFR were more likely to result in electrolyte disturbances, while coagulation dysfunction was influenced by liver disease and decreased eGFR, with female sex being protective.</p> Conclusions <p>This real-world study demonstrated that the safety profile of tislelizumab-based regimens is comparable to that observed in clinical trials, with hematological, hepatic, renal, and immune systems most commonly affected. Several clinical and biochemical factors were identified as potential risk factors for trAEs. Given the single-center retrospective design and lack of a comparator group, these findings should be considered exploratory and need for validation in prospective, multicenter studies to better inform clinical management.</p>

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Exploratory safety analysis of tislelizumab-based regimens in patients with lung cancer: a retrospective real-world study

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  • 发表日期：

    2026年7月29日

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  • Jinyu Liu,
  • Qi Zhang,
  • Xihan Lin,
  • Yanwen Nuo,
  • Ruxu You

摘要

Background

Programmed death-1 (PD-1) inhibitors, including tislelizumab, are used in China and other countries for the treatment of lung cancer. However, the safety profile of tislelizumab has been poorly reported in lung cancer patients based on real-world data. This study aimed to evaluate the incidence of treatment-related adverse events (trAEs) and identify associated risk factors.

Methods

A retrospective, single-center study was conducted using electronic medical records of 212 lung cancer patients treated with tislelizumab-based regimens between February 2021 and February 2023. TrAEs were assessed using the Common Terminology Criteria for Adverse Events, version 5.0. Logistic regression analysis was performed to identify risk factors for trAEs.

Results

Among 212 patients, 98.11% experienced at least one trAE, and 19.81% experienced grade 3–4 trAEs. The most commonly affected systems were hematological (91.98%), hepatobiliary (66.51%), renal (55.19%), and immune (40.57%). The most frequent trAEs included anemia (83.96%), decreased lymphocyte count (53.30%), and increased lactate dehydrogenase (47.64%). Hypothyroidism (25.47%) was the most common immune-related adverse event (irAE). Severe irAEs (grade 3–4) occurred in 1.89% of patients, leading to treatment discontinuation in 4.72%. Risk factors for myelosuppression included squamous non-small cell lung cancer (sq-NSCLC) (OR 3.21, 95% CI 1.48–6.95, P = 0.003) and combination therapy with chemotherapy (OR 3.44, 95% CI 1.79–6.59, p < 0.001). Abnormal liver function was associated with cerebrovascular disease (OR 5.38, 95% CI 1.35–21.49, P = 0.017), elevated alanine aminotransferase (ALT) levels (OR 3.74, 95% CI 1.27–11.00, P = 0.016), and decreased creatinine levels (OR 38.82, 95% CI 2.54–592.59, P = 0.009). Renal dysfunction was linked to sq-NSCLC (OR 4.60, 95% CI 2.16–9.82, p < 0.001), decreased eGFR (OR 4.31, 95% CI 2.19–8.48, p < 0.001), and current smoking status (OR 2.75, 95% CI 1.06–7.16, P = 0.038). Thyroid dysfunction was strongly associated with elevated thyrotropin levels (OR 8.09, 95% CI 2.11–31.02, P = 0.002) and cardiovascular disease (OR 4.07, 95% CI 1.75–9.45, P = 0.001). Sq-NSCLC, decreased levels of creatinine and eGFR were more likely to result in electrolyte disturbances, while coagulation dysfunction was influenced by liver disease and decreased eGFR, with female sex being protective.

Conclusions

This real-world study demonstrated that the safety profile of tislelizumab-based regimens is comparable to that observed in clinical trials, with hematological, hepatic, renal, and immune systems most commonly affected. Several clinical and biochemical factors were identified as potential risk factors for trAEs. Given the single-center retrospective design and lack of a comparator group, these findings should be considered exploratory and need for validation in prospective, multicenter studies to better inform clinical management.