title: Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads: results from the PRECISION V randomized trial.
abstract: OBJECTIVE
  The purpose of our study was to evaluate hepatic, gastrointestinal, and cardiac toxicity after PRECISION transarterial chemoembolization (TACE) with drug-eluting beads (DEB) versus conventional TACE with doxorubicin in the treatment of intermediate-stage hepatocellular carcinoma (HCC).
  
  
  METHODS
  Two hundred twelve patients (185 men and 27 women; mean age, 67 years) were randomized to TACE with DEB or conventional TACE. The majority of patients (67% in both groups) presented in a more advanced stage. Safety was measured by rate of adverse events (Southwest Oncology Group criteria) and changes in laboratory parameters. Cardiotoxicity was assessed with left ventricular ejection fraction (LVEF) mainly on MRI or echocardiography.
  
  
  RESULTS
  The mean maximum postchemoembolization alanine transaminase increase in the DEB group was 50% less than in the conventional TACE group (p < 0.001) and 41% less in respect to aspartate transaminase (p < 0.001). End-of-study values returned to approximately baseline levels but with greater variability in conventional TACE patients. Treatment-emergent adverse events in the hepatobiliary system organ class occurred in 16.1% of DEB group patients compared with 25% of conventional TACE patients. There were fewer liver toxicity events in the DEB group. There was a small but statistically significant difference in mean change from baseline in LVEF between the two groups of 4 percentage points for the conventional TACE group (95% CI, 0.71-7.3; p = 0.018).
  
  
  CONCLUSIONS
  PRECISION TACE with DEB loaded with doxorubicin offers a safe therapy option for intermediate-stage HCC, even in patients with more advanced liver disease.
authors.affiliation: Department of Diagnostic and Interventional Radiology, Johann Wolfgang Goethe University Hospital, Theodor Stern Kai 7, D-60590 Frankfurt am Main, Germany. t.vogl@em.uni-frankfurt.de
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Vogl
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Riccardo
authors.initials: R
authors.lastname: Lencioni
authors.forename: Katerina
authors.initials: K
authors.lastname: Malagari
authors.forename: Anthony
authors.initials: A
authors.lastname: Watkinson
authors.forename: Frank
authors.initials: F
authors.lastname: Pilleul
authors.forename: Alban
authors.initials: A
authors.lastname: Denys
authors.forename: Clara
authors.initials: C
authors.lastname: Lee
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis / Q000209:etiology*; D016461:Chemoembolization, Therapeutic / Q000379:methods; D016009:Chi-Square Distribution; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects*; D004452:Echocardiography; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000175:diagnosis; D006331:Heart Diseases / Q000139:chemically induced* / Q000175:diagnosis; D006801:Humans; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D008863:Microspheres; D011379:Prognosis; D011446:Prospective Studies; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004317:Doxorubicin