- Anti-programmed cell death 1 (PD-1) protein agents were rapidly adopted in clinical practice after the US Food and Drug Administration (FDA) approval.
- Patients treated in clinical practice were significantly older vs those in pivotal clinical trials.
Why this matters
- The finding indicates that clinical practice can change promptly and substantially when novel cancer therapies are approved and launched.
- Gaps in knowledge of clinicians in terms of patient characteristics in clinical trials are concerning; liberal use of approved therapy without assessing patient characteristics can pose health risks.
- Study of 15,856 patients who received systemic treatment for stage III-IV melanoma, stage I-II melanoma with locoregional or distant recurrence, stage IV NSCLC, stage IV RCC, or stage I-III RCC with metastatic progression between 2011 and 2016.
- Funding: National Center for Advancing Translational Science, a component of the National Institutes of Health.
- 3089 patients were eligible for anti-PD-1 treatment.
- Overall 68.7% of eligible patients received anti-PD-1 treatment (melanoma, 79.1%; NSCLC, 65.6%; RCC, 71.2%).
- At least 60% of eligible patients in each cancer group received anti-PD-1 treatment within 4 months after FDA approval.
- No difference was observed in proportions of older and younger patients who received anti-PD-1 treatment within 9 months after approval.
- 60.6%-63.9% of patients across all cancer groups were aged >65 years in clinical practice vs 31.7%-41.0% in pivotal clinical trials (all P<.001>
- Mostly community-based practices, findings may not generalize to more advanced treatment centers.