Feasibility and Tolerance of Apatinib plus PD-1 Inhibitors for Previously Treated Advanced Gastric Cancer: A Real-World Exploratory Study.

Background: Apatinib is established to be the standard of care as third-line therapy for patients with previously treated advanced gastric cancer (GC). Programmed cell death protein 1 (PD-1) blockades also exhibited promising efficacy and safety for patients with treatment-refractory advanced GC. Objective: This study was to explore the feasibility and tolerance of apatinib plus PD-1 inhibitors for patients with previously treated advanced GC. Methods: This study was performed as a real-world study; patients with advanced GC who were treated with previous systemic chemotherapy were screened retrospectively. Eligible patients were administered with apatinib combined with PD-1 blockade treatment. Efficacy of the patients was assessed with the change of target lesion using radiological evidence according to RECIST 1.1 criteria, and follow-up was carried out regularly. A safety profile was collected and documented during the combination treatment. Univariate analysis based on baseline characteristic subgroup was implemented in univariate analysis to identify the potential factor that might contribute to progression-free survival (PFS). Results: Between August 2018 and October 2021, a total of 39 patients with advanced GC or gastroesophageal junction adenocarcinoma participated in this study consecutively and all the patients were available for efficacy and safety assessment. The best overall response during apatinib plus PD-1 blockade administration exhibited that PR was observed in 8 patients, SD was noted in 19 patients, and PD was found in 12 patients, which yielded an ORR of 20.5% (95% CI: 9.3%-36.5%), and DCR was 69.2% (95% CI: 52.4%-83.0%). Furthermore, the relatively enough follow-up had resulted in the mature PFS and overall survival (OS) data, suggesting that the median PFS of the 39 patients with advanced GC was 3.9 months (95% CI: 2.74-5.06). Additionally, the median OS of the 39 patients with advanced GC was 7.8 months (95% CI: 4.82-10.78). Furthermore, the most common adverse reactions of the 39 patients who received apatinib plus PD-1 blockades treatment were fatigue (61.5%), nausea and vomiting (56.4%), diarrhea (48.7%), hypertension (46.2%), hand-foot syndrome (38.5%), and rash (28.2%). Furthermore, performance status was independently associated with PFS of apatinib plus PD-1 inhibitor combination administration in baseline characteristic subgroup analysis. Conclusion: Apatinib plus PD-1 inhibitors exhibited promising effectiveness and acceptable tolerance for previously treated advanced GC preliminarily. And this conclusion should be confirmed in clinical trials in the future.