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.

Autor:	McKelvey BA; Friends of Cancer Research, Washington, DC., Garrett-Mayer E; American Society of Clinical Oncology, Alexandria, VA., Rivera DR; Oncology Center of Excellence, US FDA, Silver Spring, MD., Alabaster A; ConcertAI, Cambridge, MA., Andrews HS; Friends of Cancer Research, Washington, DC., Bond EG; Guardian Research Network, Spartanburg, SC., Brown TD; Syapse, San Francisco, CA., Bruno A; Syneos Health, Morrisville, NC., Damato L; Flatiron Health, New York, NY., Espirito JL; Ontada, Boston, MA., Fernandes LL; COTA, Inc, New York, NY., Hansen E; COTA, Inc, New York, NY., Kluetz P; Oncology Center of Excellence, US FDA, Silver Spring, MD., Ma X; Flatiron Health, New York, NY., McCracken A; Guardian Research Network, Spartanburg, SC., Mishra-Kalyani PS; US FDA, Silver Spring, MD., Natanzon Y; ConcertAI, Cambridge, MA., Potter D; IQVIA, Durham, NC., Robert NJ; Ontada, Boston, MA., Schwartz L; Memorial Sloan Kettering Cancer Center, New York, NY., Schwind R; Tempus AI, Inc, Chicago, IL., Sweetnam C; Syapse, San Francisco, CA., Wagner J; IQVIA, Durham, NC., Stewart MD; Friends of Cancer Research, Washington, DC., Allen JD; Friends of Cancer Research, Washington, DC.
Jazyk:	angličtina
Zdroj:	JCO clinical cancer informatics [JCO Clin Cancer Inform] 2024 Aug; Vol. 8, pp. e2400091.
DOI:	10.1200/CCI.24.00091
Abstrakt:	Purpose: Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can be challenging. Friends of Cancer Research formed a collaboration to assess available data attributes related to rw-response across RWD sources to inform methods for capturing, defining, and evaluating rw-response. Materials and Methods: This retrospective noninterventional (observational) study included seven electronic health record data companies (data providers) providing summary-level deidentified data from 200 patients diagnosed with metastatic non-small cell lung cancer (mNSCLC) and treated with first-line platinum doublet chemotherapy following a common protocol. Data providers reviewed the availability and frequency of data components to assess rw-response (ie, images, radiology imaging reports, and clinician response assessments). A common protocol was used to assess and report rw-response end points, including rw-response rate (rwRR), rw-duration of response (rwDOR), and the association of rw-response with rw-overall survival (rwOS), rw-time to treatment discontinuation (rwTTD), and rw-time to next treatment (rwTTNT). Results: The availability and timing of clinician assessments was relatively consistent across data sets in contrast to images and image reports. Real-world response was analyzed using clinician response assessments (median proportion of patients evaluable, 77.5%), which had the highest consistency in the timing of assessments. Relative consistency was observed across data sets for rwRR (median 46.5%), as well as the median and directionality of rwOS, rwTTD, and rwTTNT. There was variability in rwDOR across data sets. Conclusion: This collaborative effort demonstrated the feasibility of aligning disparate data sources to evaluate rw-response end points using clinician-documented responses in patients with mNSCLC. Heterogeneity exists in the availability of data components to assess response and related rw-end points, and further work is needed to inform drug effectiveness evaluation within RWD sources.
Databáze:	MEDLINE
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