title: Chronic thalidomide and chemoembolization for hepatocellular carcinoma.
abstract: BACKGROUND
  Transcatheter arterial chemoembolization (TACE) has been used to curtail tumor vasculature and delay tumor progression in hepatocellular carcinoma (HCC). We conducted a phase I trial to evaluate the efficacy and toxicity of thalidomide when combined with TACE in patients with advanced HCC.
  
  
  METHODS
  Between June 2000 and November 2003, 56 patients with unresectable HCC and amenable to TACE were enrolled. The starting dose of thalidomide was 200 mg/day and was escalated every 2 weeks as tolerated to a maximum dose of 1,000 mg/day. Dose reductions and discontinuation were determined by toxicity. TACE was performed 4 weeks after initiation of thalidomide therapy and repeated as necessary.
  
  
  RESULTS
  Overall, 47 and 55 patients were evaluable for response and toxicity, respectively; the median dose of thalidomide given was 200 mg/day. Three patients (6.38%) patients achieved complete responses, whereas 10 (21.3%) had partial responses, for an overall response rate of 27.7%, and 27 (57.5%) had stable disease. Median progression-free survival was 7 months (95% confidence interval [CI]: 5-10 months), and median OS was 21 months (95% CI: 16-28 months) (Fig. 1). Fatigue and lethargy (49.1%), constipation (47.3%), and nausea (43.6%) were common. Grade 3-4 toxicities consisted mostly of increased aspartate aminotransferase (43.6%) and elevated alanine aminotransferase (38.2%) (Table 1).
  
  
  CONCLUSIONS
  Thalidomide and TACE were commonly associated with nonhematologic side effects, with fatigue and constipation being prominent. With a lack of clear therapeutic benefit, this combination is unlikely to be pursued for HCC.
authors.affiliation: New York University School of Medicine, New York, New York, USA; jennifer.wu@nyumc.org.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wu
authors.affiliation: Mount Sinai School of Medicine, New York, New York, USA;
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ng
authors.affiliation: Weill Cornell Medical Center, New York, New York, USA;
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Christos
authors.affiliation: New York University School of Medicine, New York, New York, USA;
authors.forename: Alec S
authors.initials: AS
authors.lastname: Goldenberg
authors.affiliation: Montefiore Medical Center, New York, New York, USA;
authors.forename: Joseph
authors.initials: J
authors.lastname: Sparano
authors.affiliation: Mount Sinai School of Medicine, New York, New York, USA;
authors.forename: Max W
authors.initials: MW
authors.lastname: Sung
authors.affiliation: Yale Cancer Center, New Haven, Connecticut, USA.
authors.forename: Howard S
authors.initials: HS
authors.lastname: Hochster
authors.affiliation: New York University School of Medicine, New York, New York, USA;
authors.forename: Franco M
authors.initials: FM
authors.lastname: Muggia
mesh_terms: D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide