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QTc prolongation assessment in the development of anticancer medication: clinical and methodological aspects
G. Curigliano, g. Spitaleri, f. de Braud, Cardinal d., c. Onion, m. Craig, Colombo n., a. Colombo, m. Locatelli, r. Goldhirsch
Cardiac safety Assessments are commonly used in the development of investigational drugs of Clinical Oncology. In the development of anticancer medication were always more consideration to the potential of a compound of causing adverse elettrocardiografici changes, especially QT interval prolongation, that can be associated with risk for and torsades de he exhibited sudden death. Regardless of overt clinical toxicity, potentially QTc evaluation might influence the decision-making at many levels during clinical studies, including the eligibility for therapy protocol, delivery of dose or suspension and analysis of the optimal dose for subsequent development. Given the potential for serious and irreversible morbidity from adverse cardiac events, it is understandable that cardiac safety results may have broad impact on the management of conduct and patient study. The risk management methodologies of QTc prolongation for cardiac medications were developed from experience primarily of drugs used to treat diseases not fatal in a chronic setting or Antihistamines such as antibiotics. Extrapolation of these approaches to medicines to treat cancer for a period of acute may not be appropriate. Some specific guidelines is available for managing the risk of cardiac safety in the development and use of oncology drugs. In this manuscript, clinical and methodological aspects related QTc prolongation assessment will be reviewed. Discussions about the limitations being that design and development of oncology drugs will be highlighted.Efforts are needed to refine strategies for risk management, avoiding unintended consequences that negatively affect access patient and clinical development of promising new cancer treatments. a thoughtful risk management plan generated by organized collaboration between oncologists, cardiologists and regulatory agencies in support of an essential development program for oncology agents with heart problems.
Volume: 3 article number: 130 DOI: 10.3332/ecancer may.2009.130 received: 22/11/2008 published: 12/01/2009
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