Abstract
New drugs come not only with benefits but also with unexpected toxicities which need to be promptly recognized and managed. Starting from a scholar case of acute heart failure with preserved ejection fraction following the administration of trabectedin (ET-743, Yondelis®) in a patient with a metastatic solitary fibrous tumor, we performed a systematic review of the literature encompassing the results of previous cardiac safety analysis published ten years ago, a review of clinical trials published during the last 10 years as well as single-case descriptions related to trabectedin cardiotoxicity. The estimated incidence of cardiac toxicity was 3,4% among patients receiving trabectedin, with recent data suggesting a higher rate of heart failure than previously recognized. Previous or concomitant anthracyclines exposure may represent a risk factor. Assaying for NT-pro-BNP may be useful for the early detection of individuals with trabectedin-induced heart failure.
Highlights
Trabectedin is a synthetically produced tetrahydroisoquinoline alkaloid originally derived from the Caribbean marine tunicate, Ecteinascidia turbinata [1]
In a retrospective pooled analysis by Le Cesne [9] gathering 1,132 patients with solid tumors treated in phase II clinical trials with Tbt as single agent, cardiac adverse effects (CAE) of any grade occurred in twenty patients, of which three were grade 3 or 4 - one grade 3 atrial fibrillation (AF) and two heart failures (HF)
We report here a case of acute heart failure following Tbt administration in a heavily pretreated man with a solitary fibrous tumor (SFT)
Summary
Trabectedin (code ATC L01CX01, known as ecteinascidin 743 or ET-743 – Yondelis ®) is a synthetically produced tetrahydroisoquinoline alkaloid originally derived from the Caribbean marine tunicate, Ecteinascidia turbinata [1]. The approved summary of product characteristics mentions the need to monitor left ventricular ejection fraction (LVEF) before initiation and after treatment with Tbt, and recommend that an absolute decrease of LVEF ≥15%, or ≥5% if less than the lower limit of normal, should prompt drug discontinuation. These toxicities are believed to be present only in patients with ovarian cancer receiving previous or concomitant anthracyclines [7].
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