title: High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial.
abstract: This phase II trial was undertaken to determine the efficacy and toxicity of proton beam radiotherapy for patients with locally unresectable hepatocellular carcinoma. Cirrhotic patients were eligible if they had a Child-Pugh score of 10 or less. Eligible patients included those with T 1 -T 3 hepatocellular carcinoma; selected T 4 patients also were eligible. Patients with lymph node or distant metastases were ineligible. Daily proton beam radiotherapy was directed to the liver tumor with an additional 1-2 cm margin. The total dose was 63 cobalt Gray equivalents, administered in 15 divided fractions over 3 weeks. Thirty-four patients have completed treatment and have been followed up for a minimum of 6 months, with a median follow-up period of 20 months. The mean age was 65 years, and average tumor size was 5.7 cm. Posttreatment toxicity included a small but significant decline in albumin levels and increased total bilirubin; 3 experienced duodenal or colonic bleeding when bowel was immediately adjacent to the treated tumor. Two-year actuarial data showed a 75% local tumor control rate and an overall survival rate of 55%. Of patients with an elevated pretreatment alpha-fetoprotein, 85% were found to have declining alpha-fetoprotein levels from a pretreatment mean of 1405 to 35 at 6 months after treatment. Six patients underwent liver transplantation between 6 and 16 months after completion of radiotherapy with 2 showing no evidence of residual carcinoma within the explanted liver. Overall the majority of patients responded to treatment, and the therapy was well tolerated.
authors.affiliation: Department of Radiation Medicine, Loma Linda University Medical Center, 11234 Anderson Street, Loma Linda, California 92354, USA. dbush@dominion.llumc.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Bush
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Hillebrand
authors.forename: James M
authors.initials: JM
authors.lastname: Slater
authors.forename: Jerry D
authors.initials: JD
authors.lastname: Slater
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001663:Bilirubin / Q000097:blood; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000532:radiotherapy*; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D061766:Proton Therapy; D011832:Radiation Injuries; D012709:Serum Albumin
chemical_list: D012709:Serum Albumin; D001663:Bilirubin