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Background <p>The combination of anti-angiogenic agents with immune checkpoint inhibitors (ICIs) has emerged as a promising therapeutic strategy for advanced non-small cell lung cancer (NSCLC). Among these approaches, anlotinib combined with ICIs has demonstrated encouraging clinical efficacy. However, the prognostic factors associated with treatment response and clinical outcomes remain incompletely understood. This systematic review aimed to synthesize the available evidence regarding prognostic factor categories, study characteristics, and methodological approaches used to investigate factors associated with the efficacy of anlotinib plus ICIs in patients with NSCLC.</p> Methods <p>A systematic search was conducted across major databases, including PubMed/MEDLINE, Embase, Web of Science, Scopus, CENTRAL, CNKI, and Wanfang, as well as clinical trial registries, from inception to March 31, 2026. Studies evaluating prognostic factors associated with clinical outcomes in NSCLC patients treated with anlotinib combined with ICIs were included. Risk of bias was assessed using the Quality in Prognosis Studies (QUIPS) tool for observational studies and the Risk of Bias 2 (RoB 2) tool for randomized trials. Owing to substantial heterogeneity and incomplete reporting, meta-analysis was not feasible; therefore, a qualitative synthesis with structured evidence mapping was performed.</p> Results <p>A total of 1,832 records were identified, of which 12 studies met the inclusion criteria. Most included studies were retrospective and conducted in Asian populations. Several categories of prognostic factors were identified, including clinical characteristics (e.g., performance status, metastatic burden, and prior lines of therapy), treatment-related variables, and exploratory biomarkers such as PD-L1 expression and blood-based indices. However, many studies did not provide complete effect estimates for individual factors (e.g., HRs or ORs with 95% confidence intervals), limiting quantitative comparisons and preventing assessment of the consistency and magnitude of reported associations. Patients with better baseline clinical status and lower tumor burden generally experienced improved progression-free survival and overall survival. Nevertheless, substantial heterogeneity across studies limited direct comparisons.</p> Conclusion <p>Current evidence suggests that a variety of clinical and biomarker-related variables have been investigated as potential prognostic factors in NSCLC patients receiving anlotinib plus ICIs. However, incomplete reporting and considerable heterogeneity preclude definitive conclusions regarding their prognostic value. Well-designed prospective studies are needed to validate these findings and improve patient selection strategies.</p>

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Prognostic and exploratory predictor factors associated with outcomes of anlotinib plus immune checkpoint inhibitors in advanced non-small cell lung cancer: a systematic review with evidence mapping

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月31日

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  • Deyong Zhang,
  • Mingjun Hu,
  • Zhiqiang Cai

摘要

Background

The combination of anti-angiogenic agents with immune checkpoint inhibitors (ICIs) has emerged as a promising therapeutic strategy for advanced non-small cell lung cancer (NSCLC). Among these approaches, anlotinib combined with ICIs has demonstrated encouraging clinical efficacy. However, the prognostic factors associated with treatment response and clinical outcomes remain incompletely understood. This systematic review aimed to synthesize the available evidence regarding prognostic factor categories, study characteristics, and methodological approaches used to investigate factors associated with the efficacy of anlotinib plus ICIs in patients with NSCLC.

Methods

A systematic search was conducted across major databases, including PubMed/MEDLINE, Embase, Web of Science, Scopus, CENTRAL, CNKI, and Wanfang, as well as clinical trial registries, from inception to March 31, 2026. Studies evaluating prognostic factors associated with clinical outcomes in NSCLC patients treated with anlotinib combined with ICIs were included. Risk of bias was assessed using the Quality in Prognosis Studies (QUIPS) tool for observational studies and the Risk of Bias 2 (RoB 2) tool for randomized trials. Owing to substantial heterogeneity and incomplete reporting, meta-analysis was not feasible; therefore, a qualitative synthesis with structured evidence mapping was performed.

Results

A total of 1,832 records were identified, of which 12 studies met the inclusion criteria. Most included studies were retrospective and conducted in Asian populations. Several categories of prognostic factors were identified, including clinical characteristics (e.g., performance status, metastatic burden, and prior lines of therapy), treatment-related variables, and exploratory biomarkers such as PD-L1 expression and blood-based indices. However, many studies did not provide complete effect estimates for individual factors (e.g., HRs or ORs with 95% confidence intervals), limiting quantitative comparisons and preventing assessment of the consistency and magnitude of reported associations. Patients with better baseline clinical status and lower tumor burden generally experienced improved progression-free survival and overall survival. Nevertheless, substantial heterogeneity across studies limited direct comparisons.

Conclusion

Current evidence suggests that a variety of clinical and biomarker-related variables have been investigated as potential prognostic factors in NSCLC patients receiving anlotinib plus ICIs. However, incomplete reporting and considerable heterogeneity preclude definitive conclusions regarding their prognostic value. Well-designed prospective studies are needed to validate these findings and improve patient selection strategies.