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

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. 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. 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. The combination of anlotinib and PD-1/PD-L1 blockade has promising efficacy and safety as a second-line or subsequent therapy for SCLC.