BACKGROUND: Cardiovascular disease (CVD) has become an increasingly common limitation to effective anticancer

Abstract

BACKGROUND: Cardiovascular disease (CVD) has become an 

increasingly common limitation to effective anticancer 

therapy. Yet, whether CVD events were consistently 

reported in pivotal trials supporting contemporary 

anticancer drugs is unknown.

OBJECTIVES: The authors sought to evaluate the 

incidence, consistency, and nature of CVD event 

reporting in cancer drug trials.

METHODS: From the Drugs@FDA, clinicaltrials.gov, 

MEDLINE, and publicly available U.S. Food and Drug 

Administration (FDA) drug reviews, all reported CVD 

events across latter-phase (II and III) trials 

supporting FDA approval of anticancer drugs from 1998 

to 2018 were evaluated. The primary outcome was the 

report of major adverse cardiovascular events (MACE), 

defined as incident myocardial infarction, stroke, 

heart failure, coronary revascularization, atrial 

fibrillation, or CVD death, irrespective of treatment 

arm. The secondary outcome was report of any CVD event. 

Pooled reported annualized incidence rates of MACE in 

those without baseline CVD were compared with reported 

large contemporary population rates using relative 

risks. Population risk differences for MACE were 

estimated. Differences in drug efficacy using pooled 

binary endpoint hazard ratios on the basis of the 

presence or absence of reported CVD were also assessed.

RESULTS: Overall, there were 189 trials, evaluating 123 

drugs, enrolling 97,365 participants (58.5 ± 5 years, 

46.0% female, 72.5% on biologic, targeted, or immune-

based therapies) with 148,138 person-years of follow-

up. Over a median follow-up of 30 months, 1,148 

incidents of MACE (375 heart failure, 253 myocardial 

infarction, 180 strokes, 65 atrial fibrillation, 29 

revascularizations, and 246 CVD deaths; 792 in the 

intervention vs. 356 in the control arm; p < 0.01)< 

0.01),

CONCLUSIONS: Among pivotal clinical trials linked to 

contemporary FDA-approved cancer drugs, reported CVD 

event rates trail expected population rates.

PMID: 32057377 [PubMed - in process]

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pubmed: ctoall&ca or conall

Optimal management of coronary artery disease in cancer 

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