Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads: Results from the PRECISION V randomized trial

Thomas J. Vogl, Johannes Lammer, Riccardo Lencioni, Katerina Malagari, Anthony Watkinson, Frank Pilleul, Alban Denys, Clara Lee

Research output: Contribution to journalArticle

112 Citations (Scopus)

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). SUBJECTS AND 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). CONCLUSION. PRECISION TACE with DEB loaded with doxorubicin offers a safe therapy option for intermediate-stage HCC, even in patients with more advanced liver disease.

Original languageEnglish (US)
JournalAmerican Journal of Roentgenology
Volume197
Issue number4
DOIs
StatePublished - Oct 2011
Externally publishedYes

Fingerprint

Hepatocellular Carcinoma
Liver
Pharmaceutical Preparations
Stroke Volume
Doxorubicin
Aspartate Aminotransferases
Alanine Transaminase
Echocardiography
Cardiotoxicity
Liver Diseases
Therapeutics
Safety

Keywords

  • Doxorubicin
  • Drug-eluting bead embolization
  • Hepatocellular carcinoma (HCC)
  • Toxicity
  • Transarterial chemoembolization (TACE)

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads : Results from the PRECISION V randomized trial. / Vogl, Thomas J.; Lammer, Johannes; Lencioni, Riccardo; Malagari, Katerina; Watkinson, Anthony; Pilleul, Frank; Denys, Alban; Lee, Clara.

In: American Journal of Roentgenology, Vol. 197, No. 4, 10.2011.

Research output: Contribution to journalArticle

Vogl, Thomas J. ; Lammer, Johannes ; Lencioni, Riccardo ; Malagari, Katerina ; Watkinson, Anthony ; Pilleul, Frank ; Denys, Alban ; Lee, Clara. / Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads : Results from the PRECISION V randomized trial. In: American Journal of Roentgenology. 2011 ; Vol. 197, No. 4.
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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). SUBJECTS AND 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). CONCLUSION. PRECISION TACE with DEB loaded with doxorubicin offers a safe therapy option for intermediate-stage HCC, even in patients with more advanced liver disease.",
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T2 - Results from the PRECISION V randomized trial

AU - Vogl, Thomas J.

AU - Lammer, Johannes

AU - Lencioni, Riccardo

AU - Malagari, Katerina

AU - Watkinson, Anthony

AU - Pilleul, Frank

AU - Denys, Alban

AU - Lee, Clara

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N2 - 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). SUBJECTS AND 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). CONCLUSION. PRECISION TACE with DEB loaded with doxorubicin offers a safe therapy option for intermediate-stage HCC, even in patients with more advanced liver disease.

AB - 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). SUBJECTS AND 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). CONCLUSION. PRECISION TACE with DEB loaded with doxorubicin offers a safe therapy option for intermediate-stage HCC, even in patients with more advanced liver disease.

KW - Doxorubicin

KW - Drug-eluting bead embolization

KW - Hepatocellular carcinoma (HCC)

KW - Toxicity

KW - Transarterial chemoembolization (TACE)

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