title: Effect of selection of QTc formula on eligibility of cancer patients for phase I clinical trials.
abstract: 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.
authors.affiliation: Mayo Clinic Arizona, Scottsdale, AZ 85259, USA. borad.mitesh@mayo.edu
authors.forename: Mitesh J
authors.initials: MJ
authors.lastname: Borad
authors.forename: Arundhati D
authors.initials: AD
authors.lastname: Soman
authors.forename: Martin
authors.initials: M
authors.lastname: Benjamin
authors.forename: Daniel
authors.initials: D
authors.lastname: Casa
authors.forename: Waibhav D
authors.initials: WD
authors.lastname: Tembe
authors.forename: Barbara F
authors.initials: BF
authors.lastname: Piper
authors.forename: Ramesh
authors.initials: R
authors.lastname: Ramanathan
authors.forename: Raoul
authors.initials: R
authors.lastname: Tibes
authors.forename: Gayle
authors.initials: G
authors.lastname: Jameson
authors.forename: Karen
authors.initials: K
authors.lastname: Ansaldo
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Von Hoff
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017321:Clinical Trials, Phase I as Topic; D004562:Electrocardiography; D005260:Female; D006339:Heart Rate / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000503:physiopathology*; D018579:Patient Selection; D055815:Young Adult