TUESDAY, Jan. 31 (HealthDay News) -- Two new drugs, taken alone
or potentially together, may boost survival for men with advanced
prostate cancer, studies suggest.
The results were so promising that both trials were stopped
early to make sure all participants could benefit from the
Men enrolled in both studies had what's known as "metastatic
castration-resistant prostate cancers" -- tumors that had continued
to grow and spread despite standard treatment aimed at lowering
testosterone levels. (The male hormone testosterone is thought to
feed prostate cancer).
The data were presented in San Francisco on Tuesday as part of
the Genitourinary Cancers Symposium, sponsored in part by the
American Society of Clinical Oncology (ASCO).
According to ASCO, more than 241,000 men in the United States
will be diagnosed with prostate cancer in 2012, and 28,000 men will
die from the disease.
Prostate cancer often spreads to the bone, but one of the new
drugs, called radium-223 chloride (Ra-223), improved survival and
delayed cancer-related bone problems in men with advanced,
spreading tumors, the researchers said. The first in a new class of
prostate cancer medications, Ra-223 delivers bursts of radiation to
the bone, targeting the tumor.
The study included 922 men with advanced prostate cancer that
had spread to the bone. The men were randomly selected to receive
either Ra-223 plus best supportive care or a placebo along with
similar care. Supportive care was aimed at alleviating the symptoms
of the cancer, including pain.
The new drug seemed to help, boosting survival to an average of
14 months compared with just over 11 months for those on the
placebo. Additionally, the average time to the first bone-break,
fracture or need for radiation or surgery was significantly delayed
among men treated with the new drug compared to their counterparts
who received placebo -- from 8.4 months without Ra-223 to 13.6
months with it. The treatment also appeared safe, the research team
"The U.S. Food and Drug Administration said it will fast track [this drug], and I don't think additional data will be required," study lead author Dr. Oliver Sartor, professor of cancer research at the Tulane University School of Medicine in New Orleans, said at a meeting press briefing. He said the hope is that this drug will be available to patients in 2012. Ra-223 is being developed by Algeta ASA and Bayer Healthcare. The study was funded by Algeta ASA.
In a second trial, another experimental medicine, called
MDV3100, appeared to boost survival by close to five months among
men with advanced prostate cancer. This drug works by preventing
male sex hormones (such as testosterone) from binding to receptors
on cancer cells (the tumor needs these hormones to survive and
In the study, close to 1,200 men received either MDV3100 or an
inactive placebo. Median overall survival was 18.4 months for men
treated with the experimental drug compared with 13.6 months for
those receiving placebo.
The new drug also reduced the risk of death by 37 percent
compared to placebo, the researchers said.
Side effects included fatigue, diarrhea and hot flushes, and
were generally considered mild, lead author Dr. Howard Scher, chief
of the genitourinary oncology service and chair of Urologic
Oncology at Memorial Sloan-Kettering Cancer Center in New York
City, said at the press briefing. This drug is being developed by
Medivation and Astellas Pharma. The study was funded by
"This is very impressive and unprecedented," added Dr. Nicholas Vogelzang, chair and medical director of the developmental therapeutics committee of U.S. Oncology, a research network specializing in cancer clinical trials. He moderated the press conference announcing the new study results. "This is going to change the way we take care of patients who we see in the office," he said.
The real gold may be in combining the two therapies, the experts
theorized. "These drugs are going to be used in sequence and we
would expect the survival to be fairly dramatically pushed
forward," according to Scher. "There will be a major bump up in the
overall survival of this group of patients in the next two to three
Vogelzang agreed: "The synergistic benefit will have to be
demonstrated, but it is very plausible that combining and
sequencing these agents may add even more value than what we see
here." He was a co-investigator on the Ra-223 study.
Findings presented at medical meetings are typically considered
preliminary until they have been published in a peer-reviewed
There's much more on prostate cancer at the
American Cancer Society.
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