التفاصيل البيبلوغرافية
| العنوان: |
Characterizing the Feasibility and Performance of Real-World Tumor Progression End Points and Their Association With Overall Survival in a Large Advanced Non–Small-Cell Lung Cancer Data Set. |
| المؤلفون: |
Griffith, Sandra D., Miksad, Rebecca A., Calkins, Geoff, You, Paul, Lipitz, Nicole G., Bourla, Ariel B., Williams, Erin, George, Daniel J., Schrag, Deborah, Khozin, Sean, Capra, William B., Taylor, Michael D., Abernethy, Amy P. |
| المصدر: |
JCO Clinical Cancer Informatics; 8/12/2019, Vol. 3, p1-13, 13p |
| مصطلحات موضوعية: |
NON-small-cell lung carcinoma, CANCER invasiveness, MEDICAL databases, ELECTRONIC health records, PROGRESSION-free survival |
| مستخلص: |
PURPOSE: Large, generalizable real-world data can enhance traditional clinical trial results. The current study evaluates reliability, clinical relevance, and large-scale feasibility for a previously documented method with which to characterize cancer progression outcomes in advanced non–small-cell lung cancer from electronic health record (EHR) data. METHODS: Patients who were diagnosed with advanced non–small-cell lung cancer between January 1, 2011, and February 28, 2018, with two or more EHR-documented visits and one or more systemic therapy line initiated were identified in Flatiron Health's longitudinal EHR-derived database. After institutional review board approval, we retrospectively characterized real-world progression (rwP) dates, with a random duplicate sample to ascertain interabstractor agreement. We calculated real-world progression-free survival, real-world time to progression, real-world time to next treatment, and overall survival (OS) using the Kaplan-Meier method (index date was the date of first-line therapy initiation), and correlations between OS and other end points were assessed at the patient level (Spearman's ρ). RESULTS: Of 30,276 eligible patients,16,606 (55%) had one or more rwP event. Of these patients, 11,366 (68%) had subsequent death, treatment discontinuation, or new treatment initiation. Correlation of real-world progression-free survival with OS was moderate to high (Spearman's ρ, 0.76; 95% CI, 0.75 to 0.77; evaluable patients, n = 20,020), and for real-world time to progression correlation with OS was lower (Spearman's ρ, 0.69; 95% CI, 0.68 to 0.70; evaluable patients, n = 11,902). Interabstractor agreement on rwP occurrence was 0.94 (duplicate sample, n = 1,065) and on rwP date 0.85 (95% CI, 0.81 to 0.89; evaluable patients n = 358 [patients with two independent event captures within 30 days]). Median rwP abstraction time from individual EHRs was 18.0 minutes (interquartile range, 9.7 to 34.4 minutes). CONCLUSION: We demonstrated that rwP-based end points correlate with OS, and that rwP curation from a large, contemporary EHR data set can be reliable, clinically relevant, and feasible on a large scale. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
