title: The prognostic significance of left ventricular ejection fraction in patients with advanced cancer treated in phase I clinical trials.
abstract: BACKGROUND
  New targeted agents may cause acute cardiac events. The purpose of our study was to investigate the incidence and the prognostic significance of left ventricular ejection fraction (LVEF) in phase I trials.
  
  
  METHODS
  Between October 2008 and September 2011, the records of 1166 consecutive patients with advanced cancer treated in the Phase I Clinic who underwent echocardiography were retrospectively reviewed.
  
  
  RESULTS
  Most of the patients were White (78%), and the most common tumor types were colorectal cancer and melanoma. Of 1166 patients, 177 (15.2%) patients had an LVEF of <50%. No difference in overall survival (OS) between patients with LVEF ≥ 50% and patients with LVEF < 50% was seen (median OS 7.4 versus 7.0 months, P = 0.84). Patients with LVEF ≤ 35% had shorter survival compared with those with LVEF between 35% and 50% (median 4.2 versus 8.0 months; P = 0.005). In multivariate analysis of patients with LVEF < 50%, independent factors predicting longer survival were LVEF > 35%, ≤2 prior systemic therapies, ≤2 metastatic sites, and normal lactate dehydrogenase and albumin levels.
  
  
  CONCLUSIONS
  Echocardiography would improve patient selection for enrollment in phase I clinical trials. These data suggest that it is safe to treat patients with LVEF between 35% and 50%.
authors.affiliation: Department of Investigational Cancer Therapeutics.
authors.forename: R
authors.initials: R
authors.lastname: Said
authors.forename: J
authors.initials: J
authors.lastname: Banchs
authors.forename: J
authors.initials: J
authors.lastname: Wheler
authors.forename: K R
authors.initials: KR
authors.lastname: Hess
authors.forename: G
authors.initials: G
authors.lastname: Falchook
authors.forename: S
authors.initials: S
authors.lastname: Fu
authors.forename: A
authors.initials: A
authors.lastname: Naing
authors.forename: D
authors.initials: D
authors.lastname: Hong
authors.forename: S
authors.initials: S
authors.lastname: Piha-Paul
authors.forename: Y
authors.initials: Y
authors.lastname: Ye
authors.forename: E
authors.initials: E
authors.lastname: Yeh
authors.forename: R A
authors.initials: RA
authors.lastname: Wolff
authors.forename: A M
authors.initials: AM
authors.lastname: Tsimberidou
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D018579:Patient Selection; D011379:Prognosis; D012189:Retrospective Studies; D013318:Stroke Volume
keywords: biomarker; cardiac dysfunction; malignancy and phase I trial