title: Transarterial hepatic chemoembolization with 70-150 µm drug-eluting beads: assessment of clinical safety and liver toxicity profile.
abstract: OBJECTIVE
  To assess the incidence and severity of adverse events (AEs) in the form of clinical symptoms and liver/biliary injuries (LBI) in patients with hepatic malignancies treated with transarterial chemoembolization using 70-150 μm drug-eluting beads (DEBs).
  
  
  METHODS
  A single-institution retrospective analysis was performed in 37 patients (25 patients with hepatocellular carcinoma and 12 patients with metastatic disease) who underwent 43 sessions of segmental/subsegmental 70-150 μm DEB transarterial chemoembolization with doxorubicin (38 sessions) or irinotecan (5 sessions). Patient inclusion criteria included the presence of the following lesion features: small diameter (≤ 3 cm), hypovascular, or with areas of residual disease after other locoregional therapies. Mean tumor diameter was 3.4 cm. Mean imaging and clinical follow-up periods were 171 days and 373 days, respectively. Clinical, laboratory, and imaging data were used to identify and classify clinically symptomatic AEs per session and LBI per patient according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Predictors for the occurrence of LBI were evaluated by logistic regression analysis.
  
  
  RESULTS
  No grade 4 or 5 AEs were recorded. Clinically symptomatic AEs occurred in 29 (67.4%) sessions (grade 1-2, 28 sessions; grade 3, 1 session), all constituting postembolization syndrome. Asymptomatic LBI occurred in 11 (29.7%) patients (grade 1, 8 patients; grade 2, 3 patients). The mean time between 70-150 μm DEB transarterial chemoembolization session and appearance of LBI was 71 days (range, 21-223 d). No predictive factors for the development of LBI were identified.
  
  
  CONCLUSIONS
  Transarterial chemoembolization with 70-150 μm DEBs was considered safe in the present study population given the acceptably low incidence and severity of AEs.
authors.affiliation: Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722. Electronic address: bcodisio@mdanderson.org.
authors.forename: Bruno C
authors.initials: BC
authors.lastname: Odisio
authors.affiliation: Department of Diagnostic Radiology (A.A.), The University of Texas Medical School at Houston, Houston, Texas.
authors.forename: Aaron
authors.initials: A
authors.lastname: Ashton
authors.affiliation: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Yuanqing
authors.initials: Y
authors.lastname: Yan
authors.affiliation: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Wei
authors.initials: W
authors.lastname: Wei
authors.affiliation: Department of Gastrointestinal (GI), Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Kaseb
authors.affiliation: Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Wallace
authors.affiliation: Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Jean N
authors.initials: JN
authors.lastname: Vauthey
authors.affiliation: Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Gupta
authors.affiliation: Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX 77030-3722.
authors.forename: Alda L
authors.initials: AL
authors.lastname: Tam
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001649:Bile Duct Diseases / Q000175:diagnosis / Q000209:etiology; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006528:Carcinoma, Hepatocellular / Q000098:blood supply / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004337:Drug Carriers; D005260:Female; D006801:Humans; D007238:Infarction / Q000175:diagnosis / Q000209:etiology; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000098:blood supply / Q000556:secondary / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D061214:Patient Safety; D011169:Portal Vein; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013781:Texas; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden; D020246:Venous Thrombosis / Q000175:diagnosis / Q000209:etiology
chemical_list: D000970:Antineoplastic Agents; D004337:Drug Carriers; D000077146:Irinotecan; D004317:Doxorubicin; D002166:Camptothecin