A new study has shown that clinical data taken from electronic health records (EHRs) of “real-world” patients with non-small cell lung cancer (NSCLC) and linked with comprehensive genomic profiling (CGP) results supported clinical, genomic, and therapeutic associations previously reported or observed in this patient group.1
In the study, Gaurav Singal, MD, of Foundation Medicine, and colleagues linked EHRs with CGP results for 28,998 patients from 275 oncology practices. They identified 4064 patients with NSCLC and conducted exploratory analyses for associations between tumor genomics and patients characteristic with clinical outcomes.
“The replication of clinicogenomic correlations previously identified through clinical trials, institutional studies, and academic sequencing efforts help establish the validity and applicability of this method,” the researchers wrote.
Of the patients, 21.4% had an alteration of EGFR, ALK, or ROS1. Among patients with driver mutations, an improved overall survival was observed among those treated with targeted therapies compared with those not treated with targeted therapy (median of 18.6 months vs. 11.4 months).
Tumor mutational burden was significantly higher among smokers compared with nonsmokers (P <.001) and significantly lower in patients with an alteration in EGFR (P <.001), RET (P =.004), ALK (P <.001), or ROS1 (P =.03).
Finally, in patients treated with anti-PD-1/PD-L1 therapies, a tumor mutational burden of 20 or more was associated with improved overall survival (P <.001).
In an accompanying editorial, Ethan Basch, MD, MSc, of University of North Carolina at Chapel Hill, and Deborah Schrag, MD, of the Dana-Farber Cancer Institute, Boston, Massachusetts, wrote that this study demonstrates “the ability to define a population of ‘real’ patients via deidentified linking of EHRs and genomic data,” suggesting the “potential for future real-world data-based clinical research to identify clinical trial ‘participants’ using similar methods.” 2
“The study by Singal and colleagues provides a glimpse at both the well-recognized power of data linkages to evaluate patterns of care and the unrealized potential to accelerate drug discovery,” they wrote. “Although no drug has yet been approved or received a new indication based on real-world evidence, the ultimate role of this information in drug development remains to be determined.” 2
Disclosure: The study by Singal and colleagues was sponsored by Flatiron Health.
Correction: The headline of this article was corrected on 4/23/19 to better reflect the study’s conclusions.
- Singal G, Miller PG, Agarwala V, et al. Association of patient characteristics and tumor genomics with clinical outcomes among patients with non-small cell lung cancer using a clinicogenomic database. JAMA. 2019;321(14):1391-1399.
- Basch E, Schrag D. The evolving uses of “real-world” data. JAMA. 2019:321(14):1359-1360.