Τίτλος:
Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads: Results from the PRECISION V randomized trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © American Roentgen Ray Society.
Συγγραφείς:
Vogl, T.J.
Lammer, J.
Lencioni, R.
Malagari, K.
Watkinson, A.
Pilleul, F.
Denys, A.
Lee, C.
Περιοδικό:
AJR. AMERICAN JOURNAL OF ROENTGENOLOGY
Λέξεις-κλειδιά:
alanine aminotransferase; alpha fetoprotein; aspartate aminotransferase; bilirubin; doxorubicin; gelatin sponge; iodinated poppyseed oil; iohexol; iomeprol; iomerol; iopamidol; microsphere; polyvinyl alcohol; unclassified drug, abdominal pain; aged; alanine aminotransferase blood level; article; aspartate aminotransferase blood level; bilirubin blood level; cancer staging; cardiotoxicity; chemoembolization; controlled study; drug delivery system; drug dosage form comparison; drug efficacy; drug eluting bead; drug fever; drug induced disease; drug safety; drug withdrawal; echocardiography; fatigue; female; gastrointestinal toxicity; heart left ventricle ejection fraction; hepatobiliary disease; hepatobiliary system; human; infection; infestation; laboratory test; liver cell carcinoma; liver toxicity; major clinical study; male; nausea; nuclear magnetic resonance imaging; outcome assessment; particle size; postembolization syndrome; priority journal; prospective study; protein blood level; randomized controlled trial; risk benefit analysis; side effect; single blind procedure; upper abdominal pain; vomiting, Aged; Antimetabolites, Antineoplastic; Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Chi-Square Distribution; Doxorubicin; Drug-Induced Liver Injury; Echocardiography; Female; Gastrointestinal Diseases; Heart Diseases; Humans; Liver Function Tests; Liver Neoplasms; Magnetic Resonance Imaging; Male; Microspheres; Prognosis; Prospective Studies; Single-Blind Method; Survival Rate; Treatment Outcome
