Abstract
BackgroundBrain metastases (BMs) indicate poor outcomes and are commonly excluded in immunotherapy clinical trials in advanced lung cancer; moreover, the effect of BM status on immunotherapy efficacy is inconsistent and inconclusive. Therefore, we conducted a meta-analysis to assess the influence of BM status on immunotherapy efficacy in advanced lung cancer.MethodsElectronic databases and all major conference proceedings were searched without language restrictions according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We extracted randomized clinical trials on lung cancer immunotherapy that had available overall survival (OS) and/or progression-free survival (PFS) data based on the BM status. All analyses were performed using random effects models.ResultsFourteen randomized clinical trials with 9,089 patients were identified. Immunotherapy conferred a survival advantage to BM patients [OS-hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58–0.90; P = 0.004; and PFS-HR, 0.68; 95% CI, 0.52–0.87, P = 0.003]. Non-BM patients could also derive a survival benefit from immunotherapy (OS-HR, 0.76; 95% CI, 0.71–0.80; P <0.001; and PFS-HR, 0.68; 95% CI, 0.56–0.82, P <0.001). The pooled ratios of OS-HRs and PFS-HRs reported in BM patients versus non-BM patients were 0.96 (95% CI, 0.78–1.18; P = 0.72) and 0.97 (95% CI, 0.79–1.20; P = 0.78), respectively, indicating no statistically significant difference between them. Subsequent sensitivity analyses did not alter the results. Subgroup analyses according to tumor type, line of therapy, immunotherapy type, study design, and representation of BM patients reconfirmed these findings.ConclusionWe demonstrated that BM status did not significantly influence the immunotherapy efficacy in lung cancer, suggesting that both BM and non-BM patients could obtain comparable benefits.Systematic Review Registration https://www.crd.york.ac.uk/prospero/, identifier (CRD42020207446).
Highlights
Brain metastases (BMs) are common and potentially devastating complications in advanced lung cancer, leading to a decreased quality of life and extremely poor prognosis [1, 2]
Immunotherapy conferred a survival advantage to BM patients [overall survival (OS)-hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58–0.90; P = 0.004; and progression-free survival (PFS)-HR, 0.68; 95% CI, 0.52–0.87, P = 0.003]
The pooled ratios of OS-HRs and PFS-HRs reported in BM patients versus non-BM patients were 0.96 and 0.97, respectively, indicating no statistically significant difference between them
Summary
Brain metastases (BMs) are common (approximately 20–40% of cases) and potentially devastating complications in advanced lung cancer, leading to a decreased quality of life and extremely poor prognosis [1, 2]. Many literatures focus on immunotherapy in lung cancer, whether the efficacy of lung cancer immunotherapy differs based on the BM status remains unclear, mainly because of limited data in this area, on the BM patients. BMs may negatively affect outcomes in patients treated with immunotherapy, and these patients are typically excluded in clinical trials, partly due to poor drug transport across the blood– brain barrier, the risk of brain pseudo-progression, and the use of high-dose corticosteroids [9,10,11]. Given the poor prognosis of BM patients and potential negative effect on outcomes, there is a clear need to evaluate whether immunotherapy has comparable efficacy between BM and non-BM patients. Brain metastases (BMs) indicate poor outcomes and are commonly excluded in immunotherapy clinical trials in advanced lung cancer; the effect of BM status on immunotherapy efficacy is inconsistent and inconclusive. We conducted a meta-analysis to assess the influence of BM status on immunotherapy efficacy in advanced lung cancer
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