Cabazitaxel Extends Lives of Men With No More Treatment Options
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Reviewed By Louise Chang, MD
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 years."
As many as 20,000 men in the U.S. could benefit from the drug each year, he says.
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 groups.
Cabazitaxel for Prostate Cancer: How It Works
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 weeks.
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 says.
Also, 6% 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 planned.
SOURCES: 2010 Genitourinary Cancers Symposium, San Francisco, March 5-7, 2010.
Oliver Sartor, MD, Piltz Professor for Cancer Research, Tulane Cancer Center, New Orleans.
Nicholas J. Vogelzang, MD, spokesman, American Society of Clinical Oncology; chair, developmental therapeutics committee, U.S. Oncology, Las Vegas.
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