In a retrospective cohort study reported in JAMA Oncology, O’Connor et al found that anti–programmed cell death protein 1 (PD-1) agents rapidly reached eligible patients after U.S. Food and Drug Administration (FDA) approval. The study also showed that real-world patients were significantly older than patients enrolled in pivotal clinical trials.
The study involved patients from the Flatiron Health Network from January 2011 through August 2016 who were eligible for anti–PD-1 treatment of melanoma, non–small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). The primary outcome of interest was the cumulative proportions of eligible patients receiving anti–PD-1 treatment and their age distributions.
The analysis identified 3,089 eligible patients with median ages of 66 to 67 years in the 3 disease cohorts. Overall, 1,742 patients (56.4%) were male and 2,066 (66.9%) were white. Among these, 2,123 eligible patients (68.7%) received anti–PD-1 treatment, including 439 patients with melanoma (79.1%), 1,417 with NSCLC (65.6%), and 267 with RCC (71.2%). Within 4 months after FDA approval, > 60% of eligible patients in each disease cohort had received anti–PD-1 agent treatment.
Within 9 months after FDA approval, the proportions of older vs younger patients receiving nivolumab (Opdivo) for melanoma, NSCLC, or RCC or pembrolizumab (Keytruda) for melanoma or NSCLC were similar in clinical practice. However, larger proportions of anti–PD-1–treated patients were older in real-world cohorts.
Thus, 60.6% (827 of 1,365) to 63.9% (46 of 72) were aged ≥ 65 years, and 27.7% (74 of 267) to 36.7% (105 of 286) were aged ≥ 75 years in the 3 disease real-world cohorts, compared with ranges of 31.7% (38 of 120) to 41.0% (223 of 544) aged ≥ 65 years, and 8.3% (34 of 410) to 11.7% (14 of 120) aged ≥ 75 years in pivotal clinical trials (pairwise P < .001 for all comparisons).
The investigators concluded, “Anti–PD-1 agents rapidly reached patients in clinical practice, and patients treated in clinical practice differed significantly from patients treated in pivotal clinical trials. Future actions are needed to ensure that rapid adoption occurs on the basis of representative trial evidence.”
The work was supported by a grant from the National Center for Advancing Translational Science of the National Institutes of Health.
Cary P. Gross, MD, of the Department of Internal Medicine, Yale University School of Medicine, is the corresponding author for the JAMA Oncology article.
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