Publications

Background ESR1 mutations (ESR1m) are known drivers of resistance to aromatase inhibitors. While ESR1m has been linked to worse survival outcomes, clonal complexity over time has not been well-evaluated in a real-world context. Here we characterized longitudinal dynamics of ESR1m, including rare point mutation emergence and polyclonality in hormone receptor- positive/HER2-negative metastatic breast cancer (HR+/HER2- … Continued

Abstract Introduction: Real-world data (RWD) offers a valuable tool for identifying novel prognostic factors in heterogeneous diseases. We leveraged the Tempus multimodal RWD database to analyze outcomes for patients with advanced epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma (PPC). Our primary objective was to apply machine learning (ML) models to identify and evaluate clinical … Continued

Background: Fam-trastuzumab deruxtecan-nxki (T-DXd) has shown clinical benefit in HER2-positive and HER2-low metastatic breast cancer (MBC), but resistance remains a barrier to durable response. To investigate resistance mechanisms, real-world data (RWD) from a large, clinically annotated cohort were analyzed to identify molecular correlates and potential therapeutic vulnerabilities. Methods: A retrospective analysis of RWD from 300 MBC patients … Continued

Background: Molecular surveillance adoption in hormone receptor-positive, HER2-negative metastatic breast cancer (HR+/HER2- mBC) has potential to inform critical treatment decisions in patients (pts) treated with aromatase inhibitor (AI) plus CDK4/6 inhibitor (CDK4/6i) therapy with detected ESR1 mutations (ESR1m). ESR1m patterns remain poorly characterized in real-world practice. We characterized ESR1m emergence and clinical impact in a … Continued

Abstract Purpose – Real-world data (RWD) from electronic health records (EHRs) and next-generation sequencing are increasingly used to study treatment effectiveness in molecularly refined patient populations. Incomplete mortality data in EHR can overestimate survival rates in RWD studies. While the National Death Index (NDI) is the gold standard for mortality data in the United States, … Continued

OBJECTIVES: Immune checkpoint blockade (ICB) represents an advance in cancer care, and has introduced novel toxicities, called immune-related AEs (irAEs). Accurate irAEs identification in real-world data (RWD) is vital for assessing the long-term safety profile ICB. A barrier to this identification is a lack of consensus in the definitions of AEs. Here, we apply three … Continued

OBJECTIVES: Integrating real-world data (RWD) sources can enable increasingly granular precision oncology studies. Comparisons between data sources typically report aggregate statistics from unlinked datasets, but this approach precludes analysis of patient-specific date agreements. In this study, we leverage deterministic patient linkages to benchmark claims oncology treatment data against abstracted electronic health records (EHR) in a … Continued

OBJECTIVES: The CARE Initiative seeks to advance understanding of when real-world data (RWD) can generate valid treatment effectiveness estimates by emulating randomized controlled trials (RCTs). We present findings from three oncology RCT emulations. METHODS: Following feasibility assessments of candidate RCTs in available U.S. data sources, we emulated the KEYNOTE-189 (metastatic NSCLC) trial of first-line pembrolizumab+chemotherapy … Continued

OBJECTIVES: Assessing the quality of Real-World Data (RWD) is crucial as we increasingly rely on RWD to support regulatory decisions and improve patient outcomes. This study aimed to develop a robust, context-specific framework to quantify RWD quality, particularly for oncology applications. The framework was designed to enable standardized comparisons across RWD sources and systematically evaluate … Continued

OBJECTIVES The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative seeks to advance understanding of when real-world data (RWD) can generate valid treatment effectiveness estimates by emulating oncology randomized controlled trials (RCTs) using RWD. Successful emulation requires fit-for-emulation data. We describe learnings from a structured feasibility assessment process to evaluate potential … Continued