Efficacy and safety of anlotinib combined with PD-1/PD-L1 inhibitors as second-line and subsequent therapy in advanced small-cell lung cancer

Abstract

Objectives: Treatments for advanced small-cell lung cancer (SCLC) patients who are resistant to first-line chemotherapy are limited. Given that antiangiogenic agents and immune-checkpoint inhibitors (ICIs) can confer synergistic therapeutic benefits, combination therapy should be considered. We explored the efficacy and safety of combination therapy with anlotinib and programmed cell death protein 1 (PD-1)/programmed cell death-ligand 1 (PD-L1) inhibitors as second-line and subsequent therapy for advanced SCLC. Materials and Methods: We reviewed advanced SCLC patients at Shanghai Chest Hospital who had received anlotinib in combination with ICIs from November 2016 to November 2020 as second- and subsequent-line treatment. Patients with advanced SCLC who had received paclitaxel monotherapy as second-line treatment were included as the control group. Results: A total of 141 patients were included in the final analysis (40 in the combination therapy group and 101 in the paclitaxel monotherapy group). The median progression-free survival (PFS) times for the combination therapy and paclitaxel monotherapy groups were 3.40 and 2.83 months (p = 0.022), respectively, while the median overall survival (OS) times for the combination therapy and paclitaxel monotherapy groups were 8.20 and 5.87 months (p = 0.048), respectively. Hypertension and hepatic dysfunction were the most pronounced adverse events of combination therapy and two patients changed regimens due to severe fatigue and anorexia. Conclusion: The combination of anlotinib and PD-1/PD-L1 blockade has promising efficacy and safety as a second-line or subsequent therapy for SCLC.