Abstract
PurposeCardiovascular disease (CVD) is the leading cause of morbidity and mortality in cancer survivors, particularly after chest radiation therapy (RT). However, the extent to which CVD events are consistently reported in contemporary prospective trials is unknown. Methods and MaterialsFrom 10 high-impact RT, oncology, and medicine journals, we identified all latter phase trials from 2000 to 2019 enrolling patients with breast, lung, lymphoma, mesothelioma, or esophageal cancer wherein chest-RT was delivered. The primary outcome was the report of major adverse cardiac events (MACEs), defined as incident myocardial infarction, heart failure, coronary revascularization, arrhythmia, stroke, or CVD death across treatment arms. The secondary outcome was the report of any CVD event. Multivariable regression was used to identify factors associated with CVD reporting. Pooled annualized incidence rates of MACEs across RT trials were compared with contemporary population rates using relative risks (RRs). ResultsThe 108 trials that met criteria enrolled 59,070 patients (mean age, 58.0 ± 10.2 years; 46.0% female), with 273,587 person-years of available follow-up. During a median follow-up of 48 months, 468 MACEs were reported (including 96 heart failures, 75 acute coronary syndrome, 1 revascularization, 94 arrhythmias, 28 strokes, and 20 CVD deaths; 307 occurred in the intervention arms vs 144 in the control arms; RR, 1.96; P < .001). Altogether, 50.0% of trials did not report MACEs, and 37.0% did not report any CVD. The overall weighted-trial incidence was 376 events per 100,000 person-years compared with 1408 events per 100,000 person-years in similar nontrial patients (RR, 0.27; P < .001). There were no RT factors associated with CVD reporting. ConclusionIn contemporary chest RT–based clinical trials, reported CVD rates were lower than expected population rates.
Highlights
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality after thoracic radiation therapy (RT) and has emerged as a well-recognized limitation of cancer therapy efficacy.[1]
The majority of trials included concurrent immune, biologic, or hormone-based therapy (98.1%), and the median trial size was 100 to 499 participants, with breast and lung cancer accounting for most included trials (Table 1)
For each respective form of major adverse cardiac events (MACEs), more than 75% of trials did not report an occurrence, and the rate of nonreporting did not vary significantly between trials including versus excluding baseline CVD (Table 2)
Summary
Cardiovascular disease (CVD) is a leading cause of morbidity and mortality after thoracic radiation therapy (RT) and has emerged as a well-recognized limitation of cancer therapy efficacy.[1]. Multiple reports in non-small cell lung cancer (NSCLC) have demonstrated that a significant proportion of cardiac events occur within approximately 2 years of RT completion.[3,4] Studies in patients with Hodgkin lymphoma,[5,6,7,8] breast cancer,[9,10,11] and NSCLC3,12 treated with RT have reported increased rates of cardiac events that rise with increasing heart dose.[3,8,10,12] These detrimental effects are pronounced even in locally advanced NSCLC and esophageal cancer, in which survival is measured in years and not decades.[3,12,13,14,15] In practice, changes to radiation delivery, including prescription RT dose, fractionation, or target volumes, are typically based on findings from a single, or at most, several landmark studies. Whether CVD is consistently reported in contemporary thoracic RT trials is unknown
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