Reliability of Conclusions from Early Analyses of Real-World Data for Newly Approved Drugs in Advanced Gastric Cancer in the United States

Lisa M Hess,1 Michael Grabner,2 Liya Wang,2 Astra M Liepa,1 Xiaohong Ivy Li,3 Zhanglin Lin Cui,3 Lee Bowman,1 William R Schelman4 1Global Patient Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 2Life Sciences Research, HealthCore Inc., Wilmington, DE, USA; 3Global Statistics, Eli Lilly and Company, Indianapolis, IN, USA; 4Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USACorrespondence: Lisa M HessEli Lilly and Company, Indianapolis, IN 46285, USAEmail Hess_lisa_m@lilly.comBackground: As real-world data resources expand and improve, there will increasingly be opportunities to study the effectiveness of interventions. There is a need to ensure that study designs explore potential sources of bias and either acknowledge or mitigate them, in order to improve the accuracy of findings. The objective of this study was to understand newly approved drug utilization patterns in real-world clinical settings over time.Methods: This retrospective study included three sources of real-world data (claims, electronic health records, and recoded data from a quality care program) collected from patients diagnosed with gastric cancer who initiated therapy with either trastuzumab or ramucirumab. Linear regression was used to investigate trends in the use of these drugs for the care of patients with gastric cancer over time from Food and Drug Administration (FDA) approval.Results: Eligible patients (n=1700) had consistent demographic and clinical characteristics over time. After regulatory approval, trastuzumab was used in later lines of therapy and then shifted to earlier lines (p=0.002), while ramucirumab utilization remained consistent over time after FDA approval (p=0.49). Ramucirumab augmentation, defined as the addition of the drug after initiation of a line of therapy, decreased over time (p=0.03), and trastuzumab augmentation remained consistent over time (p=0.58).Conclusion: Since treatment effectiveness may change across lines of treatment, bias may arise if there are changes in the use of the drug (such as line migration) during the time period of analysis using real-world data.Keywords: gastric cancer, trastuzumab, ramucirumab, bias, real-world data