Clinical Efficacy and Safety of Sintilimab Combined with Targeted Drug Therapy as Second-Line or Above Treatment for Advanced or Metastatic Gastric Cancer

Abstract As a monoclonal antibody of programmed cell death protein-1 (PD-1), sintilimab shows good therapeutic effect in combination with chemotherapy for the first-line treatment of advanced gastric cancer (GC). However, there is a lack of data on combined targeted drugs in the treatment of advanced or metastatic GC. The purpose of this study was to analyze the efficacy and safety of sintilimab combined with targeted drugs in the treatment of advanced or metastatic GC. This study retrospectively analyzed 30 patients with advanced or metastatic GC who received sintilimab in combination with targeted drugs as second-line or above treatment. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Of the 30 patients, no patients achieved complete response (CR), 2 patients (6.7%) achieved partial response (PR), 22 patients (73.3%) had stable disease (SD), 6 patients (20.0%) had progressive disease (PD). The ORR and DCR were 6.7% and 80.0%, respectively. The median PFS was 3.7months (95%CI:2.5-5.0), and the median OS was 13.6 months (95%CI:9.7 -17.6). Subgroup analysis showed that the location of the primary tumor location, liver metastasis, previous gastrectomy, and previous immunotherapy had no significant difference in PFS. Common adverse events (AEs) during treatment included anemia (53.3%), fatigue (50.0%), leukopenia (26.7%), hypothyroidism (26.7%), nausea and vomiting (23.3%), thrombocytopenia (20.0%), and neutropenia (20.0%), most of which were grade 1 and 2 AEs. There were no deaths due to AEs. The combination of sintilimab and targeted drugs has a good clinical therapeutic effect for patients with advanced or metastatic GC, and AEs are basically controllable, which can be used as a treatment option for patients with disease progression after previous treatment or patients who do not tolerate previous treatment methods.