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Purpose <p>Growing evidence suggests that immunotherapy (IM) benefits non-small cell lung cancer (NSCLC) patients without identified genetic alterations. This meta-analysis evaluates the efficacy and safety of combining IM + CH compared to chemotherapy (CH) alone or with a placebo in NSCLC patients lacking EGFR/ALK mutations and without prior systemic treatment.</p> Method <p>We performed a comprehensive search in databases including PubMed, Scopus, Web of Science, Clinicaltrial.gov, and Cochrane Library. Statistical analysis was done using R 4.2.2, with heterogeneity assessed via the Cochrane Q test and I² statistic. Publication bias was checked using funnel plots and Egger’s regression test, with a p-value &lt; 0.05 indicating significant asymmetry. A random-effects model was used to account for potential variability between studies. Subgroup analyses were conducted based on PD-L1 expression levels (&lt; 1%, 1–49%, and ≥ 50%) to evaluate differential treatment effects. All statistical tests were two-sided, and a p-value &lt; 0.05 was considered statistically significant.</p> Result <p>This meta-analysis evaluates the impact of IM + CH compared to CH alone (or with placebo) on overall survival (OS) and progression-free survival (PFS) across different PD-L1 expression levels. The findings indicate a significant survival advantage for combination therapy in the total population, with pooled hazard ratios (HRs) consistently below 1. OS showed a 32–36% reduction in the risk of death (HR: 0.6789, 95% CI: 0.6160–0.7482, <i>p</i> &lt; 0.0001), while PFS demonstrated a 44% decrease in disease progression risk (HR: 0.5412, 95% CI: 0.4665–0.6280, <i>p</i> &lt; 0.0001). Subgroup analyses confirmed survival benefits across all PD-L1 expression levels, with OS improvements of 30% (PD-L1 &lt; 1%), 39% (PD-L1 1–49%), and 38% (PD-L1 ≥ 50%). Similarly, PFS benefits were observed in all subgroups, with the greatest effect in PD-L1 ≥ 50% (HR: 0.4113, 95% CI: 0.3325–0.5087, <i>p</i> &lt; 0.0001), indicating a 59% reduction in progression risk. The risk of any grade adverse events (AEs) was comparable between IM + CH and CH alone (RR 1.0070, 95% CI: 0.9987–1.0155, <i>p</i> = 0.0986), while IM + CH significantly increased the risk of severe (grade ≥ 3) AEs (RR 1.1507, 95% CI: 1.0835–1.2221, <i>p</i> &lt; 0.0001).</p> Conclusion <p>This meta-analysis provides strong evidence that IM combined with CH is a more effective treatment strategy than CH alone or with placebo for NSCLC patients without EGFR/ALK alterations, regardless of PD-L1 expression. The combination therapy consistently improved both OS and PFS across all patient subgroups, with greater benefits observed in those with higher PD-L1 expression. For any-grade AEs, the risk slightly increases with IM + CH, but the difference is not statistically significant. However, for grade ≥ 3 AEs, IM + CH significantly raises the risk compared to CH alone or with a placebo, highlighting the need for careful monitoring in clinical practice.</p>

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Systematic review and meta analysis of efficacy and safety of immunotherapy plus chemotherapy versus chemotherapy in non small cell lung cancer without EGFR or ALK alterations

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月10日

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  • Karim Abdelazim,
  • Mohamed T. Amralla,
  • Ali A. Aboismael,
  • Shrouk A. Ghaffar,
  • Ahmed I. Elbehiry,
  • Nahla H. Badr

摘要

Purpose

Growing evidence suggests that immunotherapy (IM) benefits non-small cell lung cancer (NSCLC) patients without identified genetic alterations. This meta-analysis evaluates the efficacy and safety of combining IM + CH compared to chemotherapy (CH) alone or with a placebo in NSCLC patients lacking EGFR/ALK mutations and without prior systemic treatment.

Method

We performed a comprehensive search in databases including PubMed, Scopus, Web of Science, Clinicaltrial.gov, and Cochrane Library. Statistical analysis was done using R 4.2.2, with heterogeneity assessed via the Cochrane Q test and I² statistic. Publication bias was checked using funnel plots and Egger’s regression test, with a p-value < 0.05 indicating significant asymmetry. A random-effects model was used to account for potential variability between studies. Subgroup analyses were conducted based on PD-L1 expression levels (< 1%, 1–49%, and ≥ 50%) to evaluate differential treatment effects. All statistical tests were two-sided, and a p-value < 0.05 was considered statistically significant.

Result

This meta-analysis evaluates the impact of IM + CH compared to CH alone (or with placebo) on overall survival (OS) and progression-free survival (PFS) across different PD-L1 expression levels. The findings indicate a significant survival advantage for combination therapy in the total population, with pooled hazard ratios (HRs) consistently below 1. OS showed a 32–36% reduction in the risk of death (HR: 0.6789, 95% CI: 0.6160–0.7482, p < 0.0001), while PFS demonstrated a 44% decrease in disease progression risk (HR: 0.5412, 95% CI: 0.4665–0.6280, p < 0.0001). Subgroup analyses confirmed survival benefits across all PD-L1 expression levels, with OS improvements of 30% (PD-L1 < 1%), 39% (PD-L1 1–49%), and 38% (PD-L1 ≥ 50%). Similarly, PFS benefits were observed in all subgroups, with the greatest effect in PD-L1 ≥ 50% (HR: 0.4113, 95% CI: 0.3325–0.5087, p < 0.0001), indicating a 59% reduction in progression risk. The risk of any grade adverse events (AEs) was comparable between IM + CH and CH alone (RR 1.0070, 95% CI: 0.9987–1.0155, p = 0.0986), while IM + CH significantly increased the risk of severe (grade ≥ 3) AEs (RR 1.1507, 95% CI: 1.0835–1.2221, p < 0.0001).

Conclusion

This meta-analysis provides strong evidence that IM combined with CH is a more effective treatment strategy than CH alone or with placebo for NSCLC patients without EGFR/ALK alterations, regardless of PD-L1 expression. The combination therapy consistently improved both OS and PFS across all patient subgroups, with greater benefits observed in those with higher PD-L1 expression. For any-grade AEs, the risk slightly increases with IM + CH, but the difference is not statistically significant. However, for grade ≥ 3 AEs, IM + CH significantly raises the risk compared to CH alone or with a placebo, highlighting the need for careful monitoring in clinical practice.