title: Toxicity of irinotecan-eluting beads in the treatment of hepatic malignancies: results of a multi-institutional registry.
abstract: OBJECTIVE
  To evaluate the predictors of toxicity of drug-eluting beads loaded with irinotecan (DEBIRI) in the treatment of hepatic malignancies.
  
  
  METHODS
  A total of 330 patients were enrolled in a prospective, open-label, multicenter, multinational, single-arm study administering two types of drug-eluting beads (DEBIRI and drug-eluting beads loaded with doxorubicin). Complications were graded by Cancer Therapy Evaluation Program's Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All events requiring additional physician treatment or requiring extended hospital stay or readmission within 30 days were included.
  
  
  RESULTS
  A total of 109 patients received 187 DEBIRI treatments (range 1 to 5 per patient). The most common histology was metastatic colorectal cancer in 76% of patients, cholangiocarcinoma in 7% of patients, and other metastatic disease in 17% of patients. There were 35 patients (19%) with irinotecan treatments who sustained 158 treatment-related adverse events, with the median CTCAE event grade being CTCAE grade 2 (range 1 to 5). The most common adverse events were postembolic symptoms (42%). Multivariate analysis identified pretreatment and treatment-related risk factors as follows: lack of pretreatment with hepatic arterial lidocaine (p = 0.005), > or = 3 treatments (p = 0.05), achievement of complete stasis (p = 0.04), treatment with >100 mg DEBIRI in 1 treatment (p = 0.03), and bilirubin >2.0 microg/dl with >50% liver involvement (p = 0.05). These factors were predictive of adverse events and significantly greater hospital length of stay.
  
  
  CONCLUSIONS
  DEBIRI is safe when appropriate technique and treatment are used. Adverse events can be predicted based on pretreatment- and treatment-related factors, and their occurrence can become part of the informed consent process. Continued standardization of this treatment will lead to fewer adverse events and improved patient quality of life.
authors.affiliation: Department of Surgery, Division of Surgical Oncology, University of Louisville, Louisville, KY, USA. rcmart03@gwise.louisville.edu
authors.forename: R C G
authors.initials: RC
authors.lastname: Martin
authors.forename: J
authors.initials: J
authors.lastname: Howard
authors.forename: D
authors.initials: D
authors.lastname: Tomalty
authors.forename: K
authors.initials: K
authors.lastname: Robbins
authors.forename: R
authors.initials: R
authors.lastname: Padr
authors.forename: P M
authors.initials: PM
authors.lastname: Bosnjakovic
authors.forename: Cliff
authors.initials: C
authors.lastname: Tatum
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects* / Q000379:methods; D018281:Cholangiocarcinoma / Q000556:secondary*; D015179:Colorectal Neoplasms / Q000556:secondary*; D016001:Confidence Intervals; D004066:Digestive System Diseases / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004337:Drug Carriers / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000209:etiology; D006801:Humans; D006973:Hypertension / Q000209:etiology; D000077146:Irinotecan; D007902:Length of Stay; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D004337:Drug Carriers; D000077146:Irinotecan; D004317:Doxorubicin; D002166:Camptothecin