Early results show new prostate
cancer regimen promising
CHICAGO -- May 1, 2001 (Cancer Digest)
-- A new combination chemotherapy and steroid therapy appears
promising for men with advanced prostate cancer that no longer
responds to hormone therapy, say researchers following a small
multi-center study.
The study led by Dr. Diane Savarese, of the
University of Massachusetts Memorial Medical Center in Worcester,
Mass. was published in today's Journal of Clinical Oncology.
It showed that more than half of the men evaluated responded
to the treatment, which is better than other combinations currently
used for this advanced stage of cancer.
"This is the first multicenter trial
to show that the combination of docetaxel, estramustine and low-dose
hydrocortisone is an effective and tolerable regimen for hormone-refractory
prostate cancer," Savarese said in a prepared statement.
"The response rates are higher than those reported for other
estramustine combination regimens."
Hormone-refractory prostate cancer refers
to advanced disease in which the patient no longer responds to
conventional hormonal treatment with synthetic estrogen and antiandrogens.
Almost all men whose cancers are initially sensitive or responsive
to hormone therapy will eventually develop hormone resistance
and tumor growth.
Of the 24 men in the study with measurable
tumors, three had all signs of their tumors disappear and nine
had a 50 percent reduction or more in tumor size for at least
four weeks. Of the total of 46 men evaluated for any response
to the drug, as measured by tumor size or a blood test called
prostate specific antigen (PSA), 25 men (54%) responded to the
treatment.
Using the PSA test as a measure, 44 of the
men had high PSAs before starting the treatment, and 30 (68%)
had a 50 percent of greater decline in the PSA level in their
blood and 25 of them (57%) saw a 75 percent decline in the PSAs.
After an average (median) follow-up of 17
months, patients survived a median of 20 months from start of
the therapy.
Most of the men (56 percent) experienced a
short-lived moderate to severe loss of infection-fighting white
blood cells (neutropenia and granulocytopenia) lasting less than
a week. Severe loss of red blood cells (anemia) was uncommon.
Other side effects included infrequent nausea and vomiting, fluid
retention (edema), shortness of breath (dyspnea) and fatigue.
Overall, the findings suggest the regimen
is effective enough to warrant a larger trial comparing it to
the current standard therapy.
"Our findings support an enhanced role
for chemotherapy in the management of hormone-refractory prostate
cancer," the researchers wrote. "And the data suggest
that the docetaxel/estramustine combination may represent a new
treatment approach."
A large trial is under way to compare the
combination regimen of docetaxel and estramustine to the combination
of mitoxantrone and prednisone in the management of patients
with hormone-refractory prostate cancer, Savarese said.
The National Cancer Institute-funded study
was conducted by the research cooperative called, the Eastern
Oncology Cooperative, which is one of the largest cancer research
groups in the nation, involving 29 university medical centers,
over 185 community hospitals and 3,000 physicians.
SOURCE: Journal of Clinical Oncology,
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