Real-World Outcomes of Patients With NSCLC Treated With PD-1 Inhibitors After Approval


Certain subgroups of patients with non-small cell lung cancer (NSCLC) are underrepresented in clinical trials for newly approved programmed cell death protein 1 (PD-1) inhibitors and are needed to inform real-world treatment decisions, according to a study published in The Oncologist (online January 9, 2018; doi:10.1634/theoncologist.2017-0353).

Real-world usage patterns of PD-1 inhibitors following US Food and Drug Administration (FDA) approval are lacking and are needed to inform future studies.

Amy P Abernethy, MD, PhD, Flatiron Health (New York, NY), and colleagues conducted a multicenter analysis to determine real-world outcomes of the use of PD-1 inhibitors nivolumab and pembrolizumab during the 12 months following FDA approval in patients with metastatic NSCLC. Researchers used electronic health record data that were collected during routine care of patients treated in community cancer care clinics in the Flatiron Health network. A total of 1344 patients were selected who had at least two documented visits to the clinics from 2011 through 2016.

The primary outcome of the study was demographic and treatment characteristics of the cohort.

Researchers noted that the median age at PD-1 inhibitor initiation was 69 years (range, 61-75 years), and patients were 56% male, 88% smokers, and 65% with non-squamous histology. Additionally, 64% of patients were diagnosed having stage IV disease.

Among the total patient population, 8% (n = 112) were tested for PD-1 expression. Fifty percent received nivolumab or pembrolizumab as a second-line therapy, with a substantial proportion of third- and later-line use beginning to decline in the late months of 2015.


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Dr Abernethy and colleagues concluded that during the year following US regulatory approval of PD-1 inhibitors for the treatment of NSCLC, real-world patients were older at treatment initiation and were more likely to have a smoking history than clinical trial cohorts. “Studies of outcomes in underrepresented subgroups are needed to inform real-world treatment decisions,” they wrote.

Furthermore, they wrote that, “Evidence gathered in conventional clinical trials used to assess safety and efficacy of new therapies is not necessarily generalizable to real-world patients receiving these drugs following regulatory approval.”—Zachary Bessette