March 3, 2010 -- A new drug shows promise for extending the lives of men
with advanced prostate
cancer who have run out of treatment options.
In a large study, men given the experimental drug, called cabazitaxel, lived
an average of just over 15 months, while those given standard chemotherapy
lived an average of nearly 13 months.
Living an extra two or three months might not sound like much, but all the
men had prostate cancer that had spread throughout the body
despite standard treatment, says study head Oliver Sartor, MD, a cancer
researcher at Tulane Cancer Center in New Orleans.
"These men really don't have other alternatives," Sartor tells
WebMD."They are only expected to live about a year.
Cabazitaxel more than doubled the number of men that lived for at least two
As many as 20,000 men in the U.S. could benefit from the drug each year, he
Men with earlier prostate cancer might benefit even more, says American
Society of Clinical Oncology (ASCO) spokesman Nicholas J. Vogelzang, MD, head
of developmental therapeutics at U.S. Oncology in Las Vegas.
"These are impressive results. Advances in cancer are almost always
incremental," he tells WebMD.
Vogelzang moderated a news briefing held in advance of the 2010
Genitourinary Cancers Symposium, sponsored by ASCO and two other major cancer
About 192,000 men were diagnosed with prostate cancer in 2009 and 27,360 men
died of the disease, according to Sartor.
Cabazitaxel is a chemically modified form of the chemotherapy drug Taxotere. That's the drug of last resort for the 15,000
to 20,000 men with advanced prostate cancer that continues to spread despite
treatment to reduce the production of the hormone testosterone that fuels
prostate cancer cell growth.
But Taxotere also eventually stops working because prostate cancer cells
pump the drug out before it can exert its effects, Sartor says.
The pump appears to be unable to recognize cabazitaxel, enabling the drug to
enter and effectively kill the prostate cancer cells, he says.
Cabazitaxel for Prostate Cancer: FDA Approval Sought
The new study, called TROPIC, involved 755 men whose prostate cancer
continued to spread despite treatment with Taxotere.
About half received cabazitaxel, which is given intravenously every three
Over the five-year course of the study, men given cabazitaxel were 30% less
likely to die than those not given the drug, Sartor says. Men given cabazitaxel
also remained cancer-free for a longer period of time.
The major side effect associated with cabazitaxel was fever accompanied by declines in white blood cell
counts; it affected 7.5% of men. "This needs to be carefully monitored," Sartor
Also, 1.9% of men who took the new drug experienced severe nausea and 5% suffered severe fatigue.
Based on the findings, Sanofi-Aventis, which makes cabazitaxel and funded
the study, plans to apply for FDA approval of the drug, Sartor says.
Studies testing the drug in men with earlier-stage prostate cancer are also