Effect of selection of QTc formula on eligibility of cancer patients for phase i clinical trials

Mitesh J. Borad, Arundhati D. Soman, Martin Benjamin, Daniel Casa, Waibhav D. Tembe, Barbara F. Piper, Ramesh Ramanathan, Raoul Tibes, Gayle Jameson, Karen Ansaldo, Daniel D. Von Hoff

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

Summary: A retrospective analysis of 130 patients was conducted in a Phase I oncology clinic to assess the effect of QTc formula selection on clinical trial eligibility. QTc values were calculated from screening electrocardiograms using 7 formulae (Bazett, Fridericia, Framingham, Hodges, Mayeda, Van de Water and Wohlfart). QTc values > 470 ms for females and > 450 ms for males were used to define prolongation. Concomitant medication potential for QTc prolongation was determined using a public database (AzCert). Ineligibility rates ranged from 3.1 % to 17.7 % (Framingham: 3.1 %, Van de Water: 3.1 %, Hodges: 3.1 %, Wohlfart: 3.1 %, Fridericia: 3.9 %, Bazett: 10.8 % and Mayeda: 17.7 %). A consistent ineligibility rate was achieved by using formulae-specific thresholds. Fifty one percent of patients were taking concomitant medications with QTc prolongation potential. The proportion of concomitant medications with the potential to prolong QTc was 11.57 % (96 of 830). Uniform criteria and guidelines for selection of QTc formulae need to be developed. Formulae-specific QTc thresholds also need to be specified.

Original languageEnglish (US)
Pages (from-to)1056-1065
Number of pages10
JournalInvestigational New Drugs
Volume31
Issue number4
DOIs
StatePublished - Aug 1 2013

Keywords

  • Phase I cancer clinical trial
  • QT
  • QTc

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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    Borad, M. J., Soman, A. D., Benjamin, M., Casa, D., Tembe, W. D., Piper, B. F., Ramanathan, R., Tibes, R., Jameson, G., Ansaldo, K., & Von Hoff, D. D. (2013). Effect of selection of QTc formula on eligibility of cancer patients for phase i clinical trials. Investigational New Drugs, 31(4), 1056-1065. https://doi.org/10.1007/s10637-012-9909-4