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Background <p>Durvalumab is a selective anti-PD-L1 monoclonal antibody and an emerging perioperative treatment for resectable non-small cell lung cancer (NSCLC). However, its survival benefit, Pathological response, and safety require comprehensive evaluation.</p> Methods <p>A systematic search of PubMed/MEDLINE, Cochrane Library, and Embase (2000–2026) was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Eligible studies evaluated perioperative durvalumab (neoadjuvant, adjuvant, or both) in patients with resectable NSCLC. Primary endpoints included overall survival (OS), event-free survival (EFS), disease-free survival (DFS), major Pathological response (mPR), and Pathological complete response (pCR). Safety outcomes included grade ≥ 3 adverse events (AEs), treatment-emergent AEs (TEAEs), and discontinuation rates. Pooled meta-analysis included overall hazard ratio (HR) and risk ratio (RR) with 95% confidence intervals (CIs) for the specified outcomes. Quality of the included studies was assessed using Cochrane RoB 2.0 and JBI Critical Appraisal Checklist.</p> Results <p>Fourteen studies were included. Durvalumab treatment showed a significant trend toward improvement of EFS in the perioperative studies (HR 0.69; 95% CI: 0.61–0.78; I<sup>2</sup> = 0%). The two-arm randomized trials demonstrated increased pCR (RR = 4.16; 95% CI: 3.20–5.41; I<sup>2</sup> = 0%) and improved mPR (RR = 1.23; 95% CI: 0.12–13.01; I<sup>2</sup> = 84%) using a random-effects model. Safety outcomes were comparable between groups, with no significant increase in grade ≥ 3 AEs or TEAEs. Subgroup analyses based on treatment timing and setting also supported the main findings of the study. Sensitivity analyses for survival endpoints and mPR addressed the heterogeneity concerns by excluding the studies that contributed most to the differences within the included studies.</p> Conclusions <p>Durvalumab-based perioperative treatment strategies are associated with favorable survival trends, a robust increase in pCR, and a strong improvement in perioperative mPR across early-stage NSCLC settings.</p>

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A systematic review and meta-analysis on survival, pathological response, and safety of durvalumab in early-stage non-small cell lung cancer

  • 期刊论文

  • 发表日期：

    2026年7月10日

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  • Muhammad Imran,
  • Aziz Naeem,
  • Najmus Saqib,
  • Asma Ehsan Abbasi,
  • Aneesa Sultan

摘要

Background

Durvalumab is a selective anti-PD-L1 monoclonal antibody and an emerging perioperative treatment for resectable non-small cell lung cancer (NSCLC). However, its survival benefit, Pathological response, and safety require comprehensive evaluation.

Methods

A systematic search of PubMed/MEDLINE, Cochrane Library, and Embase (2000–2026) was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Eligible studies evaluated perioperative durvalumab (neoadjuvant, adjuvant, or both) in patients with resectable NSCLC. Primary endpoints included overall survival (OS), event-free survival (EFS), disease-free survival (DFS), major Pathological response (mPR), and Pathological complete response (pCR). Safety outcomes included grade ≥ 3 adverse events (AEs), treatment-emergent AEs (TEAEs), and discontinuation rates. Pooled meta-analysis included overall hazard ratio (HR) and risk ratio (RR) with 95% confidence intervals (CIs) for the specified outcomes. Quality of the included studies was assessed using Cochrane RoB 2.0 and JBI Critical Appraisal Checklist.

Results

Fourteen studies were included. Durvalumab treatment showed a significant trend toward improvement of EFS in the perioperative studies (HR 0.69; 95% CI: 0.61–0.78; I2 = 0%). The two-arm randomized trials demonstrated increased pCR (RR = 4.16; 95% CI: 3.20–5.41; I2 = 0%) and improved mPR (RR = 1.23; 95% CI: 0.12–13.01; I2 = 84%) using a random-effects model. Safety outcomes were comparable between groups, with no significant increase in grade ≥ 3 AEs or TEAEs. Subgroup analyses based on treatment timing and setting also supported the main findings of the study. Sensitivity analyses for survival endpoints and mPR addressed the heterogeneity concerns by excluding the studies that contributed most to the differences within the included studies.

Conclusions

Durvalumab-based perioperative treatment strategies are associated with favorable survival trends, a robust increase in pCR, and a strong improvement in perioperative mPR across early-stage NSCLC settings.