Clinical

Octreotide of no benefit in advanced HCC

Last Updated: 2007-01-26 14:39:35 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Octreotide, a long-acting somatostatin analogue, does not improve outcome in patients with advanced hepatocellular carcinoma (HCC) compared to placebo, report clinicians from University Hospital Freiburg, Germany, in the January issue of Hepatology.

Previous non-randomized and non-placebo-controlled clinical trials have suggested a positive effect of octreotide in patients with HCC. "This was clinically very important," study investigator Dr. Hubert E. Blum told Reuters Health, "because the majority of patients become symptomatic at advanced stages of the tumor (and) best supportive care is the only option available to date."

To definitively demonstrate the efficacy of octreotide, the study team, led by Dr. Gerhild Becker, randomly assigned 119 untreated patients with histologically confirmed advanced HCC, and no indication for surgery or local treatment, to octreotide (Sandostatin LAR 30 mg IM) every 4 weeks or placebo.

There was no survival difference between the two groups, the team reports. After a mean follow up of 32 months, 54 patients in the octreotide arm and 52 in the placebo arm had died. Median survival time was 4.7 months with octreotide compared with 5.3 months with placebo. Six-month survival rates were 41% with octreotide and 42% with placebo.

There was no evidence of tumor regression in any patient.

"The results from our study should discourage physicians from further prescribing this drug rather than enrolling their patients in ongoing therapeutic trials or trials in preparation," Dr. Blum told Reuters Health.

"In this context," he said, "a major area of clinical research is 'targeted HCC therapy' with small molecule inhibitors of tyrosine kinases (gefitinib, erlotinib, sorafenib and others) or monoclonal antibodies against vascular endothelial growth factor or epidermal growth factor receptor (bevacizumab, cetuximab and others)."

Thalidomide and its derivatives also hold promise as effective therapeutic agents in HCC, Dr. Blum added, and several gene therapy strategies are being explored at the pre-clinical and clinical level.

"There is hope, therefore, that in the future novel therapeutic strategies will become available to effectively treat patients with HCC at advanced multifocal stages," Dr. Blum said.

Despite this research, the clinician added, "the implementation of available measures aimed at the primary prevention of the liver diseases underlying HCC development (e.g., prevention of hepatitis B or C virus infection as well as reduction of alcohol consumption) are of paramount importance."

Hepatology 2007;45:9-15.