Representation of Patients With Cardiovascular Disease in Pivotal Cancer Clinical Trials
Heart failure (28%) was the most common exclusion criterion in clinical trials for FDA-approved anticancer therapies, followed by prior coronary disease and arrhythmias (27% and 23%, respectively). Over one-third of trials excluded patients with underlying cardiovascular disease (CVD), including more than 50% of breast cancer trials, despite the lack of evidence linking these therapies to increased CVD risk. Given the rising prevalence of CVD among cancer patients, the exclusion of such patients may skew clinical trial results, highlighting the need for more standardized and inclusive eligibility criteria to better reflect real-world populations.
Cardiovascular disease (CVD) is increasingly common among new cancer patients, with a reported prevalence near 30% at diagnosis. Cancer patients with concurrent CVD have poorer outcomes than those without CVD. Despite the high prevalence of CVD and its prognostic significance, there is limited evidence to guide the care of this increasing population. One possible explanation may be the exclusion of patients with CVD from clinical trials.
In the United States, pivotal clinical trials of anticancer drugs are reviewed by the US Food and Drug Administration (FDA) for adequate representation and safety before approval and release. However, whether patients with CVD are well represented in these important clinical trials is unknown.......
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