Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non-Small Cell Lung Cancer Treated With Chemotherapy
- Brittany A McKelvey 1, Elizabeth Garrett-Mayer 2, Donna R Rivera 3, Amy Alabaster 4, Hillary S Andrews 1, Elizabeth G Bond 5, Thomas D Brown 6, Amanda Bruno 7, Lauren Damato 8, Janet L Espirito 9, Laura L Fernandes 10, Eric Hansen 10, Paul Kluetz 3, Xinran Ma 8, Andrea McCracken 5, Pallavi S Mishra-Kalyani 11, Yanina Natanzon 4, Danielle Potter 12, Nicholas J Robert 9, Lawrence Schwartz 13, Regina Schwind 14, Connor Sweetnam 6, Joseph Wagner 12, Mark D Stewart 1, Jeff D Allen 1
- 1Friends of Cancer Research, Washington, DC.
- 2American Society of Clinical Oncology, Alexandria, VA.
- 3Oncology Center of Excellence, US FDA, Silver Spring, MD.
- 4ConcertAI, Cambridge, MA.
- 5Guardian Research Network, Spartanburg, SC.
- 6Syapse, San Francisco, CA.
- 7Syneos Health, Morrisville, NC.
- 8Flatiron Health, New York, NY.
- 9Ontada, Boston, MA.
- 10COTA, Inc, New York, NY.
- 11US FDA, Silver Spring, MD.
- 12IQVIA, Durham, NC.
- 13Memorial Sloan Kettering Cancer Center, New York, NY.
- 14Tempus AI, Inc, Chicago, IL.
- 0Friends of Cancer Research, Washington, DC.
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View abstract on PubMed
Summary
This summary is machine-generated.Real-world data (RWD) can assess drug response in metastatic non-small cell lung cancer (mNSCLC). Clinician assessments showed consistency, enabling evaluation of real-world response rates and survival outcomes.
Area Of Science
- Oncology
- Real-World Evidence
- Health Informatics
Background
- Real-world data (RWD) offers insights into drug effectiveness but presents challenges in assessing treatment response.
- Evaluating real-world (rw) response requires standardized methods for capturing and analyzing diverse data attributes.
Purpose Of The Study
- To assess available data attributes for capturing, defining, and evaluating real-world response to treatment from RWD sources.
- To inform methods for consistent assessment of drug effectiveness using real-world data.
Main Methods
- Retrospective observational study using deidentified RWD from seven electronic health record data providers.
- Included 200 patients with metastatic non-small cell lung cancer (mNSCLC) treated with first-line platinum doublet chemotherapy.
- Evaluated availability of data components (images, reports, clinician assessments) and analyzed real-world response endpoints (rwRR, rwDOR, rwOS, rwTTD, rwTTNT).
Main Results
- Clinician assessments were more consistently available and timed than images or image reports across datasets.
- Real-world response rate (rwRR) showed relative consistency (median 46.5%) using clinician assessments.
- Median and directionality of rwOS, rwTTD, and rwTTNT were relatively consistent, but rwDOR varied across datasets.
Conclusions
- Feasible to align disparate RWD sources for evaluating real-world response endpoints using clinician-documented responses in mNSCLC.
- Heterogeneity in data component availability necessitates further work to standardize drug effectiveness evaluation in RWD.
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