HOBOKEN, NJ -- January 3, 2007 -- Long-acting octreotide does not improve outcomes for patients with liver cancer compared to a placebo, according to the results of a new double blind study published in the January 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD).
Liver cancer, also known as hepatocellular carcinoma (HCC) is a common malignancy worldwide, but there are very few treatment options. While liver transplant or resection can potentially cure it, most patients are inoperable by the time they are diagnosed. More minimally invasive treatments are needed and previous studies have suggested that short-acting octreotide could improve survival for patients with HCC. Unfortunately, the twice-daily administration of the drug was associated with many side effects.
Researchers, led by Gerhild Becker, M.D. of University Hospital Freiburg in Germany aimed to examine the effects of the newly introduced long-acting octreotide on 119 patients with HCC. They conducted a multicenter, randomized, controlled, double-blind study in hopes of determining if long-acting octreotide improved survival for the cancer patients.
They enrolled 119 patients with hepatocellular carcinoma from seven hospitals in Germany and Switzerland. All patients had histologically confirmed HCC and no indication for surgery or any local treatment. Sixty of the patients received a monthly injection of 30 mg of octreotide. The other 59 received a placebo. The two groups had similar baseline characteristics, and neither the patients nor those administering the injections knew who was getting the drug and who was getting the placebo. The patients had routine follow-up exams at months 1, 3, 6, and thereafter every 6 months for at least a year. Median follow-up time was over 30 months.
At the time of final analysis, 54 patients in the octreotide group had died after a median 4.7 months. Fifty-two patients in the control group had died after a median 5.3 months. Tumor regression did not occur in any patient. The six month survival rates were 41 percent for patients in the octreotide group and 42 percent for patients in the control group.
The placebo group reported 169 side effects, compared to 161 reported by the octreotide group. In the latter cohort, the most common reported side effect was diarrhea, a known side effect of octreotide. The researchers found no significance in quality of life assessment between the two groups.
"This is the first randomized-controlled trial that analyzed the effect of long-acting octreotide on HCC growth and patient survival," the authors report. "We observed no survival improvement in HCC patients treated with octreotide in contrast to placebo treated patients."
Placebo effects are observed whenever the patient and the clinician perceive a treatment as effective. "They are often much greater than the widely accepted figure of 30 percent and can lead to erroneous claims of efficacy," the authors write. "Ideally an intervention, especially a drug trial, should be placebo controlled as in the placebo controlled double blind design of our study."
Published by John Wiley & Sons, Inc., the journal is available online via Wiley InterScience.
REFERENCE:
"Long-Acting Octreotide Versus Placebo for Treatment of Advanced HCC: A Randomized Controlled Double-Blind Study," Gerhild Becker, Hans-Peter Allgaier, Manfred Olschewski, Andreas Zähringer, Hubert Blum, Hepatology; January 2007 (DOI: 10.1002/hep.21468).
SOURCE: John Wiley & Sons, Inc.
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