CHICAGO (AP) — An experimental treatment added four months to the lives
of men with advanced prostate cancer in a study that tested an entirely new
approach to fighting the disease, doctors reported Tuesday.
Dendreon Corp.'s Provenge vaccine trains the immune system to fight tumors. It's
called a "vaccine" even though it treats disease rather than prevents it.
Doctors have been trying to develop such a therapy for decades, and this is the
first to meet a preset goal for improving survival in late-stage testing.
"There have been a lot of false starts, but this is a real start," said Dr. Paul
Schellhammer, a urologist at Eastern Virginia Medical School in Norfolk, Va.,
who led the study. Results were reported Tuesday at an American Urological
Association conference in Chicago.
Seattle-based Dendreon paid for the study, and Schellhammer owns stock in the
company. Dendreon shares fell sharply, and then trading was halted leading up to
the release of the data. Shares fell $9.74, or 45.2 percent, to $11.81. The
reason was not immediately clear.
Four months may not sound like a lot, but it is longer than the three months
afforded by Taxotere, the only chemotherapy approved for men in this situation.
Doctors hope for even greater benefit if they give the drug earlier in the
course of the disease. Dendreon would give no cost estimate for Provenge, but
other such biotech drugs cost several thousand dollars a month.
It remains to be seen if side effects will keep Provenge from winning federal
Food and Drug Administration approval. Two years ago, the FDA went against its
advisers and delayed a decision, asking for more proof of safety and
effectiveness.
The new study involved 521 men whose cancer had spread and wasn't responding to
standard hormone treatments. Two-thirds were given Provenge, a treatment that is
customized for each patient.
Doctors collect special blood cells from each patient that help the immune
system recognize cancer as a threat. They are mixed with a protein found on most
prostate cancer cells and another substance to rev up the immune system. The
resulting "vaccine" is given back to the patient as three infusions two weeks
apart.
The other one-third of men in the study had a dummy infusion.
Median survival was 26 months in men given Provenge and 22 months in the others.
Three-year survival rates were 32 percent for the Provenge group and 23 percent
for the others — a 38 percent improvement.
Strokes and other brain-related problems were no more common with Provenge — a
worry raised by earlier studies. However, four men given Provenge suffered lung
clots, though none were fatal. High blood pressure was twice as common with
Provenge. Overall, the rate of serious side effects was the same in each group.
Improving survival "is the gold standard" for any treatment, and Provenge
appears to do that, said Dr. Ira Sharlip, a urologist from the University of
California in San Francisco and a spokesman for the urological association.
Dr. Otis Brawley, the American Cancer Society's chief medical officer, said the
FDA had been right to ask for more study. But even if the drug had only extended
survival by 10 days, "I would vote for approval," he said.
One patient said it did not hurt his. Thomas Robbins, 74, of Forest City, N.C.,
was diagnosed in 2002 with prostate cancer that was growing despite hormone
treatment.
"They wanted to give me chemo," but he feared its side effects and enrolled in
the Provenge study instead. He learned afterward that he had been one of those
given the vaccine.
"Did it help me? I can't 100 percent guarantee, but I think it did," he said.
Advocacy groups cheered the results. Scott Riccio, founder of Accelerate
Progress, called them "compelling."
"For the first time, we have real clinical validation that cancer can be fought
by stimulating the body's immune system," he said in a statement. "Hundreds of
thousands of men fighting prostate cancer will now have real hope that a safe
and effective new option will be available to them in their fight for life."
Thomas Farrington, a prostate cancer survivor and founder of the Prostate Health
Education Network, said: "Prostate cancer patients finally have hope for a
better life. We are in desperate need of groundbreaking new treatments like
Provenge."
Prostate cancer is the most common non-skin cancer in American men. An estimated
186,000 new cases and 28,660 deaths from it occurred last year.
Source : The Associated Press