Reuters Health Information (2005-01-27): Thalidomide of little value for advanced hepatocellular carcinoma
Drug & Device Development
Thalidomide of little value for advanced hepatocellular carcinoma
Last Updated: 2005-01-27 12:42:14 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Though well tolerated by
most patients, thalidomide treatment of advanced hepatocellular
carcinoma (HCC) results in only modest responses, according to a report
in the January 1st issue of Cancer.
Animal studies have shown thalidomide to be effective in models of
angiogenesis, the authors explain, and clinical studies have shown it
to be potentially effective against a variety of cancers.
Dr. Albert Y. Lin from Santa Clara Valley Medical Center, San Jose,
California and colleagues investigated whether thalidomide could
improve outcomes in 27 patients with unresectable HCC, 31% of whom had
metastatic disease at the time of study entry.
With a median daily dose of thalidomide of 300 mg, the authors
report, the median time to disease progression was 42 days, and the
median survival was 123 days.
Only one patient (3.9%) experienced a partial response, the report
indicates, with his alpha-fetoprotein level falling from 34,630 ng/mL
to 18 ng/mL after 10 weeks of treatment and with radiographic imaging
showing more than 80% decrease in tumor bulk.
"These dramatic results suggest that although they are infrequent,
responses of HCC to thalidomide can occur and may be clinically
significant," the investigators write.
Patients commonly experienced fatigue, somnolence, and constipation
during therapy, the researchers note, but there were few severe adverse
events related to thalidomide treatment.
"The results of the current phase II study indicate that thalidomide
treatment in patients with unresectable HCC is relatively well
tolerated," the authors conclude. "However, the associated response
rate is modest."
"In the future," the researchers add, "combining thalidomide or the
more potent analogue CC5013 with other targeted agents, such as
epidermal growth factor receptor inhibitor, may produce better
"The study confirms the original findings of [others] who showed
that thalidomide lacks clinical activity in HCC and has relatively
increased toxic effects," writes Dr. Scott Wadler from Weill Medical
College, Cornell University School of Medicine, New York in a related
"At many institutions, thalidomide is routinely offered to patients
with HCC in lieu of enrollment into clinical trials," Dr. Wadler adds.
"The article by Lin and colleagues serves as an important course
correction for the academic oncologist."