title: A randomised phase II/III trial of 3-weekly cisplatin-based sequential transarterial chemoembolisation vs embolisation alone for hepatocellular carcinoma.
abstract: BACKGROUND
  Transarterial chemoembolisation (TACE) has not been shown to be superior to bland embolisation (TAE) for treatment of hepatocellular carcinoma (HCC).
  
  
  METHODS
  We conducted a randomised phase II/III trial in patients with untreated HCC. Patients were randomised to TAE with polyvinyl alcohol (PVA) particles alone or sequential TACE (sTACE) in which cisplatin 50 mg was administered intrarterially 4-6 h before PVA embolisation. Treatment was repeated 3-weekly for up to three treatments. The primary endpoint was overall survival and secondary endpoints were progression-free survival, toxicity and response. Target sample sizes for phase II and III were 80 and 322.
  
  
  RESULTS
  The trial was terminated at phase II after 86 patients had been randomised. Patients were well matched for prognostic criteria. All three planned treatments were given to 57.1% (TAE) and 56.8% (TACE) patients. Grade 3/4 toxicity occurred in 63.5% and 83.7%, respectively (P=0.019). End-of-treatment RECIST response (CR+PR) was 13.2 and 32.6% (P=0.04) (mRECIST 47.3% and 67.4) and median overall survival and progression-free survival was 17.3 vs 16.3 (P=0.74) months and 7.2 vs 7.5 (P=0.59), respectively.
  
  
  CONCLUSIONS
  Transarterial chemoembolisation according this novel schedule is feasible and associated with a higher response rate than TAE alone. The survival benefit of TACE over TAE remains unproven.
authors: Department of Oncology, UCL Medical School, Royal Free Campus, London NW3 2QG, UK. t.meyer@ucl.ac.uk
authors: T
authors: T
authors: Meyer
authors: A
authors: A
authors: Kirkwood
authors: M
authors: M
authors: Roughton
authors: S
authors: S
authors: Beare
authors: E
authors: E
authors: Tsochatzis
authors: D
authors: D
authors: Yu
authors: N
authors: N
authors: Davies
authors: E
authors: E
authors: Williams
authors: S P
authors: SP
authors: Pereira
authors: D
authors: D
authors: Hochhauser
authors: A
authors: A
authors: Mayer
authors: R
authors: R
authors: Gillmore
authors: J
authors: J
authors: O'Beirne
authors: D
authors: D
authors: Patch
authors: A K
authors: AK
authors: Burroughs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000628:therapy*; D016461:Chemoembolization, Therapeutic; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004621:Embolization, Therapeutic; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011788:Quality of Life; D015996:Survival Rate; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin