Abstract
PURPOSE: The purpose of this study was to evaluate the efficacy and safety of PD-1 inhibitor combined with nab-paclitaxel plus gemcitabine (AG) chemotherapy versus AG chemotherapy in the first-line treatment of advanced pancreatic cancer. PATIENTS AND METHODS: This study included the application of AG treatment and PD-1 combined with AG treatment with advanced pancreatic ductal adenocarcinoma at the Affiliated Hospital of Qingdao University from September 2018 to July 2020. Clinical information and next-generation sequencing (NGS) reports of patients were collected to compare the effectiveness and adverse events of the two treatments and analyze the risk factors affecting the prognosis of patients. RESULTS: There was no difference in PFS between the AG group and the PD-1+AG group (4.9 months vs 5.0 months, P = 0.154), but the difference in OS was statistically significant (9.3 months vs 12.1 months, P < 0.001). Compared with the AG group, the PD-1+AG group reduced the risk of death about 20.0% (HR = 0.203, 95% CI, 0.090-0.459, P < 0.001). In terms of safety, the incidence of hypothyroidism and reactive skin capillary hyperplasia in PD-1 + AG group was higher than that in AG group (P < 0.050) in grade 1-2; grade 3-4 adverse reactions were mainly hematologic AEs and abnormal liver function. The incidence of grade 3-4 adverse reactions in the two groups was 38.7% (95% CI, 20.5-56.9%) and 35.3% (95% CI, 10.0-60.6%), respectively. In addition, PD-1+ AG regimen improved the OS of patients with KRAS and TP53 co-mutations (8.0months vs 10.2 months, P = 0.004). CONCLUSION: PD-1 inhibitors combined with AG chemotherapy have shown good efficacy and safety in the first-line treatment of patients with advanced pancreatic ductal adenocarcinoma. This regimen similarly improved OS in patients with KRAS and TP53 co-mutations.