Lung cancer (Amsterdam, Netherlands) · 2026
Efficacy and safety of immunotherapy in advanced pulmonary large-cell neuroendocrine carcinoma: A systematic review and meta-analysis.
Систематический обзорСтатьяМетаанализНазвание и аннотация: Перевод в очереди
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Tsukada Akinari, Tsurumaki Nozomu, Nishimura Naoki, Nokihara Hiroshi, Izumi Shinyu, Hojo Masayuki
Аннотация
BACKGROUND: Pulmonary large-cell neuroendocrine carcinoma (LCNEC) is a rare, aggressive malignancy with limited treatment options. Management often follows small-cell lung cancer regimens; however, the benefit of immune checkpoint inhibitors (ICI) remains uncertain due to the absence of randomized trials. This systematic review and meta-analysis evaluated the clinical impact of ICI-containing regimens in advanced LCNEC.
METHODS: A comprehensive literature search of PubMed, Web of Science, and the Cochrane Library was performed through December 31, 2025. Studies evaluating ICI-containing regimens in patients with advanced LCNEC were included. Outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and grade ≥ 3 adverse events. Random-effects models were applied. Risk of bias was assessed using ROBINS-I, and publication bias using funnel plots and Egger's test.
RESULTS: Twenty-two studies involving 3,537 patients were included. The pooled ORR for chemoimmunotherapy (Chemo + ICI) was 49% (95% confidence interval [CI]: 43-55). Compared with chemotherapy alone (Chemo alone), Chemo + ICI significantly improved ORR (odds ratio [OR] 2.52; 95% CI: 1.59-4.02). The pooled median PFS was 7.4 months (95% CI: 6.1-8.1), with a significant benefit versus Chemo alone (hazard ratio [HR] 0.51; 95% CI: 0.39-0.67). In the first-line setting, Chemo + ICI improved OS (HR 0.72; 95% CI: 0.58-0.89). The incidence of grade ≥ 3 adverse events did not differ significantly between groups (OR 1.02; 95% CI: 0.64-1.64). Sensitivity analyses supported these findings.
CONCLUSION: Chemo + ICI improves clinical outcomes in patients with advanced LCNEC without increasing severe toxicity. However, substantial heterogeneity across studies warrants confirmation in prospective trials.
METHODS: A comprehensive literature search of PubMed, Web of Science, and the Cochrane Library was performed through December 31, 2025. Studies evaluating ICI-containing regimens in patients with advanced LCNEC were included. Outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and grade ≥ 3 adverse events. Random-effects models were applied. Risk of bias was assessed using ROBINS-I, and publication bias using funnel plots and Egger's test.
RESULTS: Twenty-two studies involving 3,537 patients were included. The pooled ORR for chemoimmunotherapy (Chemo + ICI) was 49% (95% confidence interval [CI]: 43-55). Compared with chemotherapy alone (Chemo alone), Chemo + ICI significantly improved ORR (odds ratio [OR] 2.52; 95% CI: 1.59-4.02). The pooled median PFS was 7.4 months (95% CI: 6.1-8.1), with a significant benefit versus Chemo alone (hazard ratio [HR] 0.51; 95% CI: 0.39-0.67). In the first-line setting, Chemo + ICI improved OS (HR 0.72; 95% CI: 0.58-0.89). The incidence of grade ≥ 3 adverse events did not differ significantly between groups (OR 1.02; 95% CI: 0.64-1.64). Sensitivity analyses supported these findings.
CONCLUSION: Chemo + ICI improves clinical outcomes in patients with advanced LCNEC without increasing severe toxicity. However, substantial heterogeneity across studies warrants confirmation in prospective trials.