High-Dose proton beam radiotherapy of hepatocellular carcinoma: Preliminary results of a phase II trial

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Gastroenterology. 2004 Nov;127(5 Suppl 2):S189-93.

High-Dose proton beam radiotherapy of hepatocellular carcinoma: Preliminary

results of a phase II trial.

Bush DA, Hillebrand DJ, Slater JM, Slater JD.

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.

PMID: 15508084 [PubMed - in process]