title: Feasibility and efficacy of high-dose three-dimensional-conformal radiotherapy in cirrhotic patients with small-size hepatocellular carcinoma non-eligible for curative therapies--mature results of the French Phase II RTF-1 trial.
abstract: OBJECTIVE
  Hepatocellular carcinoma (HCC) is a poor prognosis tumor, and only 20% of patients will benefit from curative therapies (surgery, liver transplantation, percutaneous ablation). Although conventional radiotherapy has been traditionally regarded as inefficient and toxic for cirrhotic patients, three-dimensional conformal radiotherapy (3DCRT) has provided promising preliminary data for the treatment of HCC.
  
  
  METHODS
  Prospective phase II trial including Child-Pugh A/B cirrhotic patients with small-size HCC (1 nodule < or =5 cm, or 2 nodules < or =3 cm) nonsuitable for curative treatments, to assess tolerance and efficacy of high-dose (66 Gy, 2 Gy/fraction) 3DCRT.
  
  
  RESULTS
  Twenty-seven patients were enrolled. Among the 25 assessable patients, tumor response was observed for 23 patients (92%), with complete response for 20 patients (80%), and partial response for 3 patients (12%). Stable disease was observed in 2 patients (8%). Grade 4 toxicities occurred in 2 of 11 (22%) Child-Pugh B patients only. Child-Pugh A patients tolerated treatment well, and 3/16 (19%) developed asymptomatic Grade 3 toxicities.
  
  
  CONCLUSIONS
  High-dose 3DCRT is a noninvasive, well-tolerated modality that is highly suitable for the treatment of small HCCs in cirrhotic patients, with promising results. However, additional trials are needed to optimize this technique and formally compare it with the usual curative approaches.
authors.affiliation: Department of Radiation Oncology, Centre Hospitalier Lyon-Sud, Lyon, France. francoise.mornex@chu-lyon.fr
authors.forename: Françoise
authors.initials: F
authors.lastname: Mornex
authors.forename: Nicolas
authors.initials: N
authors.lastname: Girard
authors.forename: Christophe
authors.initials: C
authors.lastname: Beziat
authors.forename: Abdul
authors.initials: A
authors.lastname: Kubas
authors.forename: Mustapha
authors.initials: M
authors.lastname: Khodri
authors.forename: Christian
authors.initials: C
authors.lastname: Trepo
authors.forename: Philippe
authors.initials: P
authors.lastname: Merle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000532:radiotherapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000209:etiology* / Q000532:radiotherapy*; D008113:Liver Neoplasms / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries / Q000209:etiology; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods*; D018570:Risk Assessment