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Background <p>Tislelizumab and Sintilimab are commonly used immunotherapy drugs in clinical practice. Only a portion of advanced NSCLC patients achieve sustained remission and long-term survival through ICI immunotherapy, while others experience disease progression post-treatment. Selecting appropriate clinical therapies and predicting treatment efficacy remain significant challenges in clinical practice. By examining the clinical efficacy and safety of tislelizumab and sintilimab combined with chemotherapy in advanced NSCLC patients within real-world settings, and analyzing prognostic factors, this study aims to provide reference for clinical treatment decisions and prognosis assessment.</p> Materials and methods <p>A retrospective analysis of clinical data from 212 patients with advanced NSCLC treated with the combination of tislelizumab or sintilimab plus chemotherapy in The First Affiliated Hospital of Dali University between March 1, 2022, and December 31, 2024. Patients were divided into the tislelizumab group (<i>n</i> = 124) and the sintilimab group (<i>n</i> = 88) based on the administered drug. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated in both groups. Kaplan-Meier methods were used to plot PFS and OS survival curves. Univariate analysis was performed using the Log-rank test, and Cox regression models were employed to identify independent prognostic factors for PFS and OS.</p> Results <p>The median progression-free survival (mPFS) in the tislelizumab group and the sintilimab group was 14.0 months (95% CI: 11.79–16.21) and 7.0 months (95% CI: 4.31–9.69), respectively (<i>P</i> = 0.005). The difference in mPFS between the two groups was statistically significant. The median overall survival (mOS) was 27.0 months (95% CI: 20.03–33.97) and 24.0 months (95% CI: 13.85–34.15) (<i>P</i> = 0.113), with no statistically significant difference in mOS between groups. ORR was 39.52% versus 18.18% (<i>P</i> &lt; 0.001), showing a statistically significant difference; DCR was 66.13% versus 70.54% (<i>P</i> = 0.506), with no statistically significant difference. After adjustment for confounders, multivariable Cox regression revealed no significant differences between the two agents for PFS (HR = 1.128, 95% CI 0.596–2.133, <i>P</i> = 0.712) or OS (HR = 0.664, 95% CI 0.378–1.165, <i>P</i> = 0.153). ADR occurrence showed a borderline association with improved OS (HR = 0.569, <i>P</i> = 0.093), but was not statistically significant. ALI, PNI, anti-angiogenic combination, and treatment line were not independent prognostic factors (all <i>P</i> &gt; 0.05).</p> Conclusion <p>In real-world clinical settings, tislelizumab combined with chemotherapy may bring potential improvements in objective response rate and progression-free survival in the short term for patients with advanced NSCLC. Nevertheless, sintilimab and tislelizumab exert comparable long-term survival benefits when used in combination with chemotherapy. After adjusting for confounding factors via multivariable regression analysis, no significant survival differences were confirmed between the two treatment regimens. Further prospective clinical studies with longer follow-up are required to verify the above conclusions.</p>

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Real-world efficacy and prognostic factor analysis of tislelizumab versus sintilimab in advanced non-small cell lung cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月22日

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  • Quanyi Liu,
  • Xiaotong Zhu,
  • Yuxuan Xie,
  • Yun Gu,
  • Lei Shen

摘要

Background

Tislelizumab and Sintilimab are commonly used immunotherapy drugs in clinical practice. Only a portion of advanced NSCLC patients achieve sustained remission and long-term survival through ICI immunotherapy, while others experience disease progression post-treatment. Selecting appropriate clinical therapies and predicting treatment efficacy remain significant challenges in clinical practice. By examining the clinical efficacy and safety of tislelizumab and sintilimab combined with chemotherapy in advanced NSCLC patients within real-world settings, and analyzing prognostic factors, this study aims to provide reference for clinical treatment decisions and prognosis assessment.

Materials and methods

A retrospective analysis of clinical data from 212 patients with advanced NSCLC treated with the combination of tislelizumab or sintilimab plus chemotherapy in The First Affiliated Hospital of Dali University between March 1, 2022, and December 31, 2024. Patients were divided into the tislelizumab group (n = 124) and the sintilimab group (n = 88) based on the administered drug. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated in both groups. Kaplan-Meier methods were used to plot PFS and OS survival curves. Univariate analysis was performed using the Log-rank test, and Cox regression models were employed to identify independent prognostic factors for PFS and OS.

Results

The median progression-free survival (mPFS) in the tislelizumab group and the sintilimab group was 14.0 months (95% CI: 11.79–16.21) and 7.0 months (95% CI: 4.31–9.69), respectively (P = 0.005). The difference in mPFS between the two groups was statistically significant. The median overall survival (mOS) was 27.0 months (95% CI: 20.03–33.97) and 24.0 months (95% CI: 13.85–34.15) (P = 0.113), with no statistically significant difference in mOS between groups. ORR was 39.52% versus 18.18% (P < 0.001), showing a statistically significant difference; DCR was 66.13% versus 70.54% (P = 0.506), with no statistically significant difference. After adjustment for confounders, multivariable Cox regression revealed no significant differences between the two agents for PFS (HR = 1.128, 95% CI 0.596–2.133, P = 0.712) or OS (HR = 0.664, 95% CI 0.378–1.165, P = 0.153). ADR occurrence showed a borderline association with improved OS (HR = 0.569, P = 0.093), but was not statistically significant. ALI, PNI, anti-angiogenic combination, and treatment line were not independent prognostic factors (all P > 0.05).

Conclusion

In real-world clinical settings, tislelizumab combined with chemotherapy may bring potential improvements in objective response rate and progression-free survival in the short term for patients with advanced NSCLC. Nevertheless, sintilimab and tislelizumab exert comparable long-term survival benefits when used in combination with chemotherapy. After adjusting for confounding factors via multivariable regression analysis, no significant survival differences were confirmed between the two treatment regimens. Further prospective clinical studies with longer follow-up are required to verify the above conclusions.