title: Phase 2 study of stereotactic body radiotherapy and optional transarterial chemoembolization for solitary hepatocellular carcinoma not amenable to resection and radiofrequency ablation.
abstract: BACKGROUND
  Curative treatment options for patients with early stage hepatocellular carcinoma (HCC) include resection, liver transplantation, and percutaneous ablation therapy. However, even patients with solitary HCC are not always amenable to these treatments. The authors prospectively investigated the clinical outcomes of patients who received stereotactic body radiotherapy (SBRT) for solitary HCC.
  
  
  METHODS
  A phase 2 study involving SBRT and optional transarterial chemoembolization (TACE) was conducted in patients with Child-Pugh grade A or B and underlying, solitary HCC (greatest tumor dimension, ≤4 cm) who were unsuitable candidates for resection and radiofrequency ablation. The prescription dose was 35 to 40 grays in 5 fractions. The primary endpoint was 3-year local tumor control.
  
  
  RESULTS
  From 2007 to 2012, 101 patients were enrolled, and 90 were evaluable with a median follow-up of 41.7 months (range, 6.8-96.2 months). Thirty-two patients were treatment-naïve, 20 were treated for newly diagnosed intrahepatic failure, and 38 were treated for residual or recurrent HCC as salvage therapy. Thirty-two patients did not receive TACE, 48 received insufficient TACE, and 10 attained full lipiodol accumulation. The 3-year local control rate was 96.3%, the 3-year liver-related cause-specific survival rate was 72.5%, and the overall survival rate was 66.7%. Grade 3 laboratory abnormalities were observed in 6 patients, and 8 patients had Child-Pugh scores that worsened by 2 points.
  
  
  CONCLUSIONS
  SBRT achieved high local control and overall survival with feasible toxicities for patients with solitary HCC, despite rather stringent conditions. SBRT can be effective against solitary HCC in treatment-naive, intrahepatic failure, residual disease, and recurrent settings, taking advantage of its distinctive characteristics. Cancer 2016;122:2041-9. © 2016 American Cancer Society.
authors.affiliation: Radiation Oncology Center, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan.
authors.forename: Atsuya
authors.initials: A
authors.lastname: Takeda
authors.affiliation: Radiation Oncology Center, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Sanuki
authors.affiliation: Radiation Oncology Center, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Tsurugai
authors.affiliation: Hepato-Biliary-Pancreatic Center, Shonan Fujisawa Tokushukai Hospital, Fujisawa, Kanagawa, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Iwabuchi
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, St Marianna University School of Medicine, Kanagawa, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Matsunaga
authors.affiliation: Department of Gastroenterology and Hepatology, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Ebinuma
authors.affiliation: Department of Gastroenterology and Hepatology, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan.
authors.forename: Kento
authors.initials: K
authors.lastname: Imajo
authors.affiliation: Radiation Oncology Center, Ofuna Chuo Hospital, Kamakura, Kanagawa, Japan.
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Aoki
authors.affiliation: Department of Pharmacotherapeutics, Faculty of Pharmacy, Keio University, Tokyo, Japan.
authors.forename: Hidetsugu
authors.initials: H
authors.lastname: Saito
authors.affiliation: Department of Radiation Oncology, Tokai University, Kanagawa, Japan.
authors.forename: Etsuo
authors.initials: E
authors.lastname: Kunieda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000706:statistics & numerical data*; D003131:Combined Modality Therapy; D004998:Ethiodized Oil / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016634:Radiosurgery / Q000706:statistics & numerical data*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D004998:Ethiodized Oil
keywords: curative treatment; hepatocellular carcinoma (HCC); noninvasive treatment; stereotactic body radiotherapy (SBRT)