Observation study is difference with randomized controlled trial and reflects the real world data in clinical practice with larger sample size, wider inclusion criteria, various interventions and long-term follow-up. We analyzed the real world data achieve real world evidence, which was applied to analyze discuses, patients, treatment patterns, resource utilization and outcome. The aim of this study was to evaluate the efficacy and safety of apatinib in real world, and provide a decision reference for Clinical practice.
This was a prospective, multicenter, non-intervention registered study. The patients (pts), were ≥18 years old, with histologically confirmed advanced gastric cancer (GC) or adenocarcinoma of esophagogastric junction (AEG), two or more lines of prior chemotherapy. All the pts were orally given apatinib at an initial dose of 500 mg until disease progression or death. Dose adjustment was allowed.
The 230 pts, included 164 males and 66 female were eligible, the average age of pts was 62 years old, stage IV was the mainly clinical stage, the main ECOG performance status was 1, 54.78% pts were given apatinib 500 mg qd. 63.91% pts were received chemotherapy along with apatinib. In the 230 pts, there were 125 received efficacy evaluation. 8 pts achieved partial response (PR), 64 had stable disease (SD), and 53 had progressive disease (PD). The objective response rate (ORR) was 6.4% and the disease control rate (DCR) was 57.6%. The middle progression free survival (mPFS) and middle overall survival (mOS) were 3.3 months and 6.3 months, respectively. Compared with the non chemotherapy, chemotherapy achieved a longer mPFS (3.8months VS 2.9 months) and mOS (8.3months VS 5.0 months). 211 pts were included for safety analysis. The incidence of adverse events (AEs) was 91.2%, The grade 3 and 4 was 62.3%. The incidence of serious adverse events (SAE) was 17.2%. Main AEs were hypertension, Hand-foot syndrome, proteinuria and fatigue. Pts received chemotherapy achieved a better tolerance.
The real world data show that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer.
Clinical trial identification
Legal entity responsible for the study
Jiang Su Cancer Hospital
All authors have declared no conflicts of interest.