American Society of Clinical Oncology Annual Meeting, Tempus-authored — Background: Friends of Cancer Research convened 9 data partners to identify data elements and common definitions for real world (rw) endpoints to evaluate populations typically excluded from clinical trials. Here we report on rwOS by frontline treatment and comorbidities.
Methods: A retrospective observational analysis of patients with aNSCLC initiating frontline platinum doublet chemotherapy (chemo) or PD-(L)1-based immuno-oncologic (IO) therapy (monotherapy or chemo combination) between 1 Jan 2011 to 31 Mar 2018 was conducted using administrative claims, EHR, and cancer registry RWD. We evaluated rwOS from frontline therapy initiation using Kaplan-Meier methods, stratified by ECOG status, brain metastases (ICD), history of chronic kidney or liver disease (CKD/ CLD, ICD), and evidence of kidney or liver dysfunction (KD/ LD, lab-based).
Results: A total of 33,649 patients were included (N 972-17,454) with 10 to 26% of patients receiving IO as frontline therapy. There was a broad range of comorbidity prevalence across datasets and patients with evidence of comorbidity had comparatively shorter 12-month OS (Table).
Conclusions: RWD analyses can generate expanded evidence on patient outcomes for populations routinely excluded from clinical trials and may help inform decision making where sparse data exist on appropriate treatment approaches. Additional understanding of data missingness, sensitivity of definitions, and covariate adjustment are needed to make direct comparisons across regimens and data sources.
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Authors: Donna R. R Rivera, Laura Lasiter, Jennifer Christian, Lindsey Enewold, Janet L. Espirito, Eric Hansen, Henry J. Henk, Lawrence H. Kushi, Daniel Lane, Yanina Natanzon, Ruth Pe Benito, Erik Rasmussen, Nicholas J. Robert, Mark Stewart, Connor Sweetnam, Olga Tymejczyk, Emily Valice, Joseph Wagner, Alia Zander, and Jeff Allen.