In:
Clinical Pharmacology & Therapeutics, Wiley, Vol. 111, No. 2 ( 2022-02), p. 444-454
Abstract:
In prior work, Friends of Cancer Research convened multiple data partners to establish standardized definitions for oncology real‐world end points derived from electronic health records (EHRs) and claims data. Here, we assessed the performance of real‐world overall survival (rwOS) from data sets sourced from EHRs by evaluating the ability of the end point to reflect expected differences from a previous randomized controlled trial across five data sources, after applying inclusion/exclusion criteria. The KEYNOTE‐189 clinical trial protocol of platinum doublet chemotherapy (chemotherapy) vs. programmed cell death protein 1 (PD‐1) in combination with platinum doublet chemotherapy (PD‐1 combination) in first‐line nonsquamous metastatic non‐small cell lung cancer guided retrospective cohort selection. The Kaplan‐Meier product limit estimator was used to calculate 12‐month rwOS with 95% confidence intervals (CIs) in each data source. Cox proportional hazards models estimated hazard ratios (HRs) and associated 95% CIs, controlled for prognostic factors. Once the inclusion/exclusion criteria were applied, the five resulting data sets included 155 to 1,501 patients in the chemotherapy cohort and 36 to 405 patients in the PD‐1 combination cohort. Twelve‐month rwOS ranged from 45% to 58% in the chemotherapy cohort and 44% to 68% in the PD‐1 combination cohort. The adjusted HR for death ranged from 0.80 (95% CI: 0.69, 0.93) to 1.15 (95% CI: 0.71, 1.85), controlling for age, gender, performance status, and smoking status. This study yielded insights regarding data capture, including ability of real‐world data to precisely identify patient populations and the impact of criteria on end points. Sensitivity analyses could elucidate data set–specific factors that drive results.
Type of Medium:
Online Resource
ISSN:
0009-9236
,
1532-6535
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2040184-X
SSG:
15,3
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