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COMPLEMENTARY PROSTATE-CANCER THERAPY GETS MAINSTREAM EXPOSURE
The nation’s leading oncology journal has raced
into print with a report on an OTC herbal supplement that
appears to lower PSA levels in men with advanced prostate cancer.
In a phase-2 study, the combination of extracts from eight
Chinese herbs, known as PC-SPES, lowered PSA levels an average
of 80% among all 32 androgen-dependent patients taking the
supplement, Dr. Eric Small of UC San Francisco and colleagues
reported in the Nov. 1 Journal of Clinical Oncology.
Though results of the study were presented in preliminary form
at the ASCO meeting in New Orleans in May, they were given rapid-
publication status by JCO. The journal didn’t comment explicitly
on the speed of publication nor did it offer comment on the
study, which was sponsored by CaP Cure.
Dr. Small said he presumed the decision to accelerate
publication was made "because PC-SPES use is on the upswing
dramatically, and it is important to disseminate information
about what this agent can and cannot achieve, and just as
important, to know about its side-effect profile."
Twenty-six of the men (81.3%) had undetectable PSA levels
following treatment, the team said. After an average follow-up
of 64 weeks, none had disease progression.
Nine of 11 patients, who hadn’t had a radical prostatectomy or
previous radiotherapy, had an average decrease in prostate size
of 22% (range 0% to 48%). Additionally, two patients with a
positive bone scan improved following the herbal treatment, as
did a patient with a bladder mass.
The agent also seemed effective for patients with hormone-
independent disease. Nineteen of 35 patients had PSA levels that
fell more than 50% (average 54%, range 0% to 99%). Eight of the
patients were refractory to ketoconazole. Among 25 patients with
a positive bone scan, two had improvement and seven achieved
stable disease.
Many of the reported side effects were similar to those seen
with androgen deprivation and estrogen therapy-loss of libido
and potency, hot flashes, and breast tenderness and enlargement.
Additionally, three patients had allergic reactions to the
supplement, 48 had leg cramps (69%), 27 had diarrhea (39%), and
10 reported nausea (14%).
Five patients had grade 4 toxicities-pulmonary embolisms in
three and hypertriglyceridemia and acute renal failure. The
researchers recommend that patients with a history of
cardiovascular disease be wary of the supplement.
The retail cost of PC-SPES through the manufacturer, Botanic
Lab, is $108 per bottle of 60 capsules. At nine capsules per
day, which was the dose in Dr. Small’s study, the cost for a
month of therapy is $453.
Dr. Mary Ann Richardson, director of the NIH’s National Center
for Complementary and Alternative Medicine, said that the
publication of this study in a mainstream journal is an important
step for complementary and alternative medicine as well as for
men with prostate cancer.
She was pleased that this study portrayed PC-SPES as another
option for prostate-cancer patients, many of whom had exhausted
all others, rather than a treatment in competition with
conventional medicine.
Meanwhile, Dr. Small said that he and a group at Boston’s
Dana-Farber Cancer Institute have embarked on a 100-patient
crossover study of PC-SPES vs. DES in androgen-independent
disease. Patients whose disease progresses switch to the other
therapy.
Thanks to Ruthie Nussbaum and Oncology Week
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