Efficacy and safety of stereotactic body radiotherapy combined with immune checkpoint inhibitors for non-small cell lung cancer: a systematic review and reconstructed individual patient data meta-analysis.
- 1Department of Thoracic Surgery and Institute of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, China.
- 2The First Clinical Medical College, Lanzhou University, Lanzhou, China.
Abstract
Stereotactic body radiotherapy (SBRT) may augment antitumor immunity when combined with immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC), but clinical studies span markedly different disease stages and treatment intents and have produced inconsistent comparative results. We aimed to synthesize the evidence and evaluate efficacy and safety, separating pairwise outcomes from descriptive single-arm outcomes. PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov were searched from inception through August 2026. Pairwise outcomes were synthesized as risk ratios (RRs) or reconstructed survival hazard ratios (HRs) and 95% confidence interval (CI). Single-arm outcomes of SBRT plus ICI were summarized as pooled proportions. Published Kaplan-Meier curves were digitized and reconstructed as individual patient data (IPD). Disease-stage and treatment-setting analyses were prespecified as descriptive because they were based on unadjusted between-study comparisons. Twenty-one studies enrolling 1,096 participants were included. Five comparative studies contributed to at least one pairwise outcome. SBRT plus ICI was not associated with statistically significant improvements in overall survival (OS) (HR 0.81, 95% CI: 0.52-1.25), progression-free survival (PFS) (HR 0.76, 95% CI: 0.53-1.10), or objective response rate (ORR) (RR 1.72, 95% CI: 0.85-3.51). Disease control rate (DCR) favored SBRT plus ICI (RR 1.20, 95% CI: 1.03-1.39), but significance was lost when either of two influential studies was omitted. Pairwise risks of any-grade and grade ≥3 adverse events (AEs) did not differ significantly. In descriptive single-arm analyses, median OS was 36.4 months (95% CI: 29.8-50.9) and median PFS was 14.6 months (95% CI: 11.6-17.2); pooled ORR was 49.4% (95% CI: 38.0-60.8%), DCR was 80.6% (95% CI: 70.9-87.7%), any-grade AE incidence was 74.2% (95% CI: 50.3-89.1%), and grade ≥3 AE incidence was 27.1% (95% CI: 17.1-40.2%). The comparative pairwise meta-analysis does not demonstrate an OS, PFS, or ORR benefit from adding SBRT to ICI-based treatment. Although the primary DCR estimate was statistically significant, its sensitivity to individual studies and the low certainty of evidence preclude a firm efficacy conclusion. Setting-specific randomized trials with standardized radiation, outcome, and toxicity definitions are needed.
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BibTeX
@article{ji2026efficacy,
title = {{Efficacy and safety of stereotactic body radiotherapy combined with immune checkpoint inhibitors for non-small cell lung cancer: a systematic review and reconstructed individual patient data meta-analysis.}},
author = {Pengfei Ji and Zhihui Zhao and Xinpu Tang and Zhangyi Dai and Xingqi Mi and Yikai Xing and Yafei Xie and Wei Liao and Xiaolong Zhang and Qiang Pu},
journal = {Translational lung cancer research},
year = {2026},
month = sep,
doi = {10.21037/tlcr-2026-0491},
url = {https://europepmc.org/article/MED/42999638},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Efficacy and safety of stereotactic body radiotherapy combined with immune checkpoint inhibitors for non-small cell lung cancer: a systematic review and reconstructed individual patient data meta-analysis.
AU - Pengfei Ji
AU - Zhihui Zhao
AU - Xinpu Tang
AU - Zhangyi Dai
AU - Xingqi Mi
AU - Yikai Xing
AU - Yafei Xie
AU - Wei Liao
AU - Xiaolong Zhang
AU - Qiang Pu
PY - 2026
DA - 2026/09/28
JO - Translational lung cancer research
DO - 10.21037/tlcr-2026-0491
UR - https://europepmc.org/article/MED/42999638
AB - Stereotactic body radiotherapy (SBRT) may augment antitumor immunity when combined with immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC), but clinical studies span markedly different disease stages and treatment intents and have produced inconsistent comparative results. We aimed to synthesize the evidence and evaluate efficacy and safety, separating pairwise outcomes from descriptive single-arm outcomes. PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov were searched from inception through August 2026. Pairwise outcomes were synthesized as risk ratios (RRs) or reconstructed survival hazard ratios (HRs) and 95% confidence interval (CI). Single-arm outcomes of SBRT plus ICI were summarized as pooled proportions. Published Kaplan-Meier curves were digitized and reconstructed as individual patient data (IPD). Disease-stage and treatment-setting analyses were prespecified as descriptive because they were based on unadjusted between-study comparisons. Twenty-one studies enrolling 1,096 participants were included. Five comparative studies contributed to at least one pairwise outcome. SBRT plus ICI was not associated with statistically significant improvements in overall survival (OS) (HR 0.81, 95% CI: 0.52-1.25), progression-free survival (PFS) (HR 0.76, 95% CI: 0.53-1.10), or objective response rate (ORR) (RR 1.72, 95% CI: 0.85-3.51). Disease control rate (DCR) favored SBRT plus ICI (RR 1.20, 95% CI: 1.03-1.39), but significance was lost when either of two influential studies was omitted. Pairwise risks of any-grade and grade ≥3 adverse events (AEs) did not differ significantly. In descriptive single-arm analyses, median OS was 36.4 months (95% CI: 29.8-50.9) and median PFS was 14.6 months (95% CI: 11.6-17.2); pooled ORR was 49.4% (95% CI: 38.0-60.8%), DCR was 80.6% (95% CI: 70.9-87.7%), any-grade AE incidence was 74.2% (95% CI: 50.3-89.1%), and grade ≥3 AE incidence was 27.1% (95% CI: 17.1-40.2%). The comparative pairwise meta-analysis does not demonstrate an OS, PFS, or ORR benefit from adding SBRT to ICI-based treatment. Although the primary DCR estimate was statistically significant, its sensitivity to individual studies and the low certainty of evidence preclude a firm efficacy conclusion. Setting-specific randomized trials with standardized radiation, outcome, and toxicity definitions are needed.
SN - 2218-6751
SN - 2226-4477
ER -