QTc prolongation induced by targeted biotherapies used in clinical practice and under investigation: a comprehensive review

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

In anticancer drug development, there has been increasing consideration for the potential of a compound to cause adverse electrocardiographic changes, especially QT interval prolongation, which can be associated with risk of torsades de pointes and sudden death. Irrespective of overt clinical toxicities, QTc assessment can influence decision making during the conduct of clinical studies, including eligibility for protocol therapy, dose delivery or discontinuation, and analyses of optimal dose for subsequent development. Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect patient access and clinical development of promising new cancer treatments. In this comprehensive review, we will analyze potential effects on QTc prolongations of targeted agents approved by regulatory agencies and under investigation. A thoughtful risk management plan was generated by an organized collaboration between oncologists, cardiologists, and regulatory agencies to support a development program essential for oncology agents with cardiac safety concerns.

Original languageEnglish
Pages (from-to)27-43
Number of pages17
JournalTargeted Oncology
Volume10
Issue number1
DOIs
Publication statusPublished - 2015

Fingerprint

Biological Therapy
Risk Management
Torsades de Pointes
Sudden Death
Decision Making
Safety
Therapeutics
Pharmaceutical Preparations
Neoplasms
Cardiologists
Oncologists
Clinical Studies

Keywords

  • Cancer treatment
  • Cardiotoxicity
  • QT<inf>c</inf> prolongation
  • Torsade de pointes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Pharmacology (medical)
  • Medicine(all)

Cite this

@article{acede3f8fcb04176b68e15c4387b42eb,
title = "QTc prolongation induced by targeted biotherapies used in clinical practice and under investigation: a comprehensive review",
abstract = "In anticancer drug development, there has been increasing consideration for the potential of a compound to cause adverse electrocardiographic changes, especially QT interval prolongation, which can be associated with risk of torsades de pointes and sudden death. Irrespective of overt clinical toxicities, QTc assessment can influence decision making during the conduct of clinical studies, including eligibility for protocol therapy, dose delivery or discontinuation, and analyses of optimal dose for subsequent development. Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect patient access and clinical development of promising new cancer treatments. In this comprehensive review, we will analyze potential effects on QTc prolongations of targeted agents approved by regulatory agencies and under investigation. A thoughtful risk management plan was generated by an organized collaboration between oncologists, cardiologists, and regulatory agencies to support a development program essential for oncology agents with cardiac safety concerns.",
keywords = "Cancer treatment, Cardiotoxicity, QT<inf>c</inf> prolongation, Torsade de pointes",
author = "Marzia Locatelli and Carmen Criscitiello and Angela Esposito and Ida Minchella and Aron Goldhirsch and Carlo Cipolla and Giuseppe Curigliano",
year = "2015",
doi = "10.1007/s11523-014-0325-x",
language = "English",
volume = "10",
pages = "27--43",
journal = "Targeted Oncology",
issn = "1776-2596",
publisher = "Springer Paris",
number = "1",

}

TY - JOUR

T1 - QTc prolongation induced by targeted biotherapies used in clinical practice and under investigation

T2 - a comprehensive review

AU - Locatelli, Marzia

AU - Criscitiello, Carmen

AU - Esposito, Angela

AU - Minchella, Ida

AU - Goldhirsch, Aron

AU - Cipolla, Carlo

AU - Curigliano, Giuseppe

PY - 2015

Y1 - 2015

N2 - In anticancer drug development, there has been increasing consideration for the potential of a compound to cause adverse electrocardiographic changes, especially QT interval prolongation, which can be associated with risk of torsades de pointes and sudden death. Irrespective of overt clinical toxicities, QTc assessment can influence decision making during the conduct of clinical studies, including eligibility for protocol therapy, dose delivery or discontinuation, and analyses of optimal dose for subsequent development. Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect patient access and clinical development of promising new cancer treatments. In this comprehensive review, we will analyze potential effects on QTc prolongations of targeted agents approved by regulatory agencies and under investigation. A thoughtful risk management plan was generated by an organized collaboration between oncologists, cardiologists, and regulatory agencies to support a development program essential for oncology agents with cardiac safety concerns.

AB - In anticancer drug development, there has been increasing consideration for the potential of a compound to cause adverse electrocardiographic changes, especially QT interval prolongation, which can be associated with risk of torsades de pointes and sudden death. Irrespective of overt clinical toxicities, QTc assessment can influence decision making during the conduct of clinical studies, including eligibility for protocol therapy, dose delivery or discontinuation, and analyses of optimal dose for subsequent development. Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect patient access and clinical development of promising new cancer treatments. In this comprehensive review, we will analyze potential effects on QTc prolongations of targeted agents approved by regulatory agencies and under investigation. A thoughtful risk management plan was generated by an organized collaboration between oncologists, cardiologists, and regulatory agencies to support a development program essential for oncology agents with cardiac safety concerns.

KW - Cancer treatment

KW - Cardiotoxicity

KW - QT<inf>c</inf> prolongation

KW - Torsade de pointes

UR - http://www.scopus.com/inward/record.url?scp=84930272408&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84930272408&partnerID=8YFLogxK

U2 - 10.1007/s11523-014-0325-x

DO - 10.1007/s11523-014-0325-x

M3 - Article

C2 - 24970120

AN - SCOPUS:84930272408

VL - 10

SP - 27

EP - 43

JO - Targeted Oncology

JF - Targeted Oncology

SN - 1776-2596

IS - 1

ER -