Immune checkpoint inhibitors (ICIs) combined with chemotherapy have become standard first-line treatments for advanced esophageal cancer. However, effective therapeutic strategies are limited after failure of immunotherapy. The combination of ICIs and anti-angiogenic agents may produce synergistic effects. Anlotinib, a multi-targeted anti-angiogenic agent, has been approved with good tolerance and efficacy in advanced ESCC. Therefore, we aimed to retrospectively analyze the efficacy and safety of anlotinib plus PD-1 inhibitors in advanced ESCC previously treated with ICIs in the real world (NCT 04984096).
We retrospectively analyzed the effects of anlotinib plus PD-1 inhibitors with unresectable locally advanced or recurrent/metastatic ESCC and must have received anti–PD-1 or anti–PD-L1 therapy previously. Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1. Baseline characteristics and adverse events (AEs) were recorded throughout the entire study.
Between July 2020 to March 2022, 29 eligible patients were included in the final analysis. At data cutoff (July 3, 2022), the ORR was 31.0 % and the DCR was 86.2%, including 9 patients with partial response (PR), 16 patients with stable disease (SD) and 4 patients with progression disease (PD). 8 (27.6%) of 29 patients had received first-line treatment, 20 patients (69.0%) had received second-line treatment and 1 (3%) patient received three lines system chemotherapy. The median PFS was 5.33 months (95% CI 4.28-6.38) and the median OS was 10.38 months (95% CI 6.26-14.48). Any treatment-related adverse events (TRAEs) occurred in all patients, anemia and lymphopenia were the most two common TRAEs, only 2 patients (6.9%) with grade 3-4 TRAEs of lymphocytopenia. All AEs could be relieved after symptomatic treatment. No treatment-related deaths occurred.
Anlotinib plus PD-1 inhibitors showed encouraging anti-tumor activity and manageable safety in advanced ESCC previously treated with ICIs, providing a feasible and well-tolerated treatment option for this patient population. The data further need to be validated in prospective study.
NCT 04984096.
Shanghai Chest Hospital.
Has not received any funding.
All authors have declared no conflicts of interest.