title: A prospective phase 2 multicenter study for the efficacy of radiation therapy following incomplete transarterial chemoembolization in unresectable hepatocellular carcinoma.
abstract: OBJECTIVE
  The purpose of this study was to investigate the efficacy and toxicity of radiation therapy (RT) following incomplete transarterial chemoembolization (TACE) in unresectable hepatocellular carcinoma (HCC).
  
  
  METHODS
  The study was designed as a prospective phase 2 multicenter trial. Patients with unresectable HCC, who had viable tumor after TACE of no more than 3 courses, were eligible. Three-dimensional conformal RT (3D-CRT) was added for HCC treatment with incomplete uptake of iodized oil, and the interval from TACE to RT was 4 to 6 weeks. The primary endpoint of this study was the tumor response after RT following incomplete TACE in unresectable HCC. Secondary endpoints were patterns of failure, progression-free survival (PFS), time to tumor progression (TTP), overall survival (OS) rates at 2 years, and treatment-associated toxicity. Survival was calculated from the start of RT.
  
  
  RESULTS
  Between August 2008 and December 2010, 31 patients were enrolled. RT was delivered at a median dose of 54 Gy (range, 46-59.4 Gy) at 1.8 to 2 Gy per fraction. A best objective in-field response rate was achieved in 83.9% of patients, with complete response (CR) in 22.6% of patients and partial response in 61.3% of patients within 12 weeks post-RT. A best objective overall response rate was achieved in 64.5% of patients with CR in 19.4% of patients and PR in 45.1% of patients. The 2-year in-field PFS, PFS, TTP, and OS rates were 45.2%, 29.0%, 36.6%, and 61.3%, respectively. The Barcelona Clinic liver cancer stage was a significant independent prognostic factor for PFS (P=.023). Classic radiation-induced liver disease was not observed. There were no treatment-related deaths or hepatic failure.
  
  
  CONCLUSIONS
  Early 3D-CRT following incomplete TACE is a safe and practical treatment option for patients with unresectable HCC.
authors.affiliation: Department of Radiation Oncology, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Chihwan
authors.initials: C
authors.lastname: Choi
authors.affiliation: Department of Radiation Oncology, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Woong Sub
authors.initials: WS
authors.lastname: Koom
authors.affiliation: Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: Tae Hyun
authors.initials: TH
authors.lastname: Kim
authors.affiliation: Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Yoon
authors.affiliation: Department of Radiation Oncology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea.
authors.forename: Jin Hee
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Radiation Oncology, Dong-A University Hospital, Dong-A University School of Medicine, Busan, Republic of Korea.
authors.forename: Hyung-Sik
authors.initials: HS
authors.lastname: Lee
authors.affiliation: Department of Radiation Oncology, Chonnam National University Hospital, Gwang-Ju, Republic of Korea.
authors.forename: Taek-Keun
authors.initials: TK
authors.lastname: Nam
authors.affiliation: Department of Radiation Oncology, Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: jsseong@yuhs.ac.
authors.forename: Jinsil
authors.initials: J
authors.lastname: Seong
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007459:Iodized Oil / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods*; D018401:Sample Size; D017211:Treatment Failure
chemical_list: D000970:Antineoplastic Agents; D007459:Iodized Oil; D004317:Doxorubicin; D002945:Cisplatin