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Journal of Clinical Oncology Report Positive

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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