The Efficacy and Safety of PD-1 Inhibitors Combined with Nab-Paclitaxel Plus Gemcitabine versus Nab-Paclitaxel Plus Gemcitabine in the First-Line Treatment of Advanced Pancreatic Cancer: A Retrospective Monocentric Study

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.

Automated summary

This study evaluated 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. The results showed that PD-1 inhibitor combined with AG chemotherapy significantly improved overall survival and had good efficacy in patients with KRAS and TP53 co-mutations.