Rationale, Design, and Feasibility of a Prospective Multicenter Registry Study of Anthracycline-Induced Cardiotoxicity (AIC Registry).

Keiko Inoue,Hiroko Bando,Masaki Ieda,Shigeru Chiba,Hiroyuki Naito,Ikuo Sekine,Rumi Sasamura,Kazuko Tajiri,Yoko Nakazawa,Noriko Iida,Momoko Murata,Nobutaka Tasaka,Kenji Nagashio,Tomoko Ishizu,Siqi Li

doi:10.3390/jcm10071370

Abstract

As the number of cancer survivors increases, cardiac management in anthracycline-treated patients has become more important. We planned to conduct a prospective multicenter registry study for comprehensive echocardiographic and biomarker data collection and an evaluation of the current practice in terms of diagnosis and management of anthracycline-induced cardiotoxicity (AIC registry). To examine the feasibility of this registry study, we analyzed the 1-year follow-up data of 97 patients registered during the first year of this registry. The AIC registry was launched in July 2016. Data on echocardiographic parameters (e.g., two-and three-dimensional [(2- and 3-D) left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS)) and biomarkers (e.g., troponin T and brain natriuretic peptide) were collected before anthracycline treatment, every 3 months during the first year after starting anthracycline, and every 6 months during the second year. Eighty-three patients (86%) completed a 1-year follow-up. The measurable rates of 2D LVEF, 3D LVEF, and GLS on each visit were nearly optimal (100%, 86–93%, and 84–94%, respectively). During the 1-year follow-up, 5 patients (6.0%) developed cardiotoxicity (a reduction in LVEF ≥ 10 percentage points from baseline and <55%). The AIC registry study is feasible and will be the first study to collect sizable echocardiographic and biomarker data on cardiotoxicity in Japanese patients treated with anthracycline in a real-world setting.

Highlights

Anthracyclines are among the most commonly used chemotherapeutic agents for the treatment of hematologic malignancies and solid tumors [1]
It is well established that the risk of heart failure (HF) secondary to anthracyclines is associated with cumulative exposure [3]
The lifetime cumulative doxorubicin-equivalent exposure is limited to 400–450 mg/m2 in order to reduce the incidence of congestive HF to less than 5%

Summary

Introduction

Anthracyclines are among the most commonly used chemotherapeutic agents for the treatment of hematologic malignancies and solid tumors [1]. Their effectiveness is impaired by the development of cardiotoxicity, which negatively affects patients’ quality of life and prognosis [2]. It is well established that the risk of heart failure (HF) secondary to anthracyclines is associated with cumulative exposure [3]. The lifetime cumulative doxorubicin-equivalent exposure is limited to 400–450 mg/m2 in order to reduce the incidence of congestive HF to less than 5%. The incidence, time of onset, responsiveness to HF therapy, and prognosis of cardiotoxicity (symptomatic and asymptomatic LVEF decline) have not been fully elucidated

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