Efficacy and safety of anlotinib combined with immune checkpoint inhibitors in the treatment of extensive-stage small cell lung cancer: a meta-analysis based on real-world data

Abstract Objective This research intended to ascertain the clinical efficacy and safety of anlotinib plus immune checkpoint inhibitors (ICIs) in patients suffering from extensive-stage small cell lung cancer (ES-SCLC). Methods Academic databases, encompassing PubMed, Embase, and the Cochrane Library, were retrieved to aggregate pertinent research, published up to March 5, 2025. The primary outcome measures covered progression-free survival (PFS), median PFS (mPFS), overall survival (OS), disease control rate (DCR), and objective response rate (ORR). Additionally, secondary outcome measures comprised partial response (PR), complete response (CR), stable disease (SD), and progressive disease (PD). Results Data pooled from 18 distinct studies, including 1,698 individuals, were synthesized and analyzed. The results revealed a statistically meaningful increase in PFS and OS for patients who received anlotinib combined with ICIs, as opposed to those receiving chemotherapy alone. Furthermore, with regard to improving ORR and DCR, anlotinib plus ICIs was significantly more efficacious than anlotinib monotherapy and chemotherapy monotherapy (P < 0.05). In comparison to chemotherapy monotherapy, anlotinib plus ICIs exhibited a notably elevated risk of thrombocytopenia (OR: 1.7, 95% CI: 1.19–2.43, P = 0.0034). However, when compared with anlotinib monotherapy, anlotinib plus ICIs did not elevate the incidence of severe adverse events (≥ grade 3). Subgroup analysis results indicated that the Eastern Cooperative Oncology Group (ECOG) performance status (PS) served as an independent predictor influencing both PFS and OS outcomes in individuals with SCLC. In contrast, neither brain metastases nor liver metastases emerged as independent prognostic factors influencing PFS and OS. Conclusion This investigation indicates that anlotinib plus ICIs can extend PFS, elevate ORR and DCR, and prolong OS in individuals with SCLC. This meta-analysis offers new insights into the treatment paradigm for SCLC, indicating that anlotinib plus ICIs can substantially ameliorate clinical outcomes in such patients.