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Old 07-13-2010, 03:32 PM
Dross Dross is offline
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Default High-risk prostate cancer associated with significantly lower bone mineral content

Men with prostate cancer lose significantly less bone mineral content (BMC) as they age than men who are free of the disease, according to research in the July 2010 issue of British Journal of Urology International (BJUI). The findings are important because loss of BMC can play a key role in the development of fragile bones, fractures and osteoporosis.

American researchers studied 519 participants who joined the Baltimore Longitudinal Study at an average age of 56 between 1973 and 1984. The maximum follow-up was 35 years and the median was 22 years. Seventy-six men who took part in the study were later diagnosed with prostate cancer, with just under a quarter (24 per cent) falling into the high-risk category.

When they charted the individual BMCs of the study subjects over an extended period, the researchers could clearly see that the decline was much larger in healthy men than in men later diagnosed with prostate cancer, especially those with high-risk prostate cancer. This occurred despite the fact that the initial baseline readings were very similar for all three groups.

The researchers also adjusted the figures to take account of other factors that affect BMC, such as smoking status, body mass index, dietary calcium and vitamin D. However, this did not change the significant differences between the healthy men and those with prostate cancer.

"There are numerous possible mechanisms to explain the relationship between prostate cancer and BMC" says lead author Dr Stacy Loeb, from Johns Hopkins University, Maryland, USA.

"It is well known that prostate cancer frequently metastasizes (spreads) to bone. Although the biology underlying the association between BMC and this form of cancer requires additional research, our findings suggest that common growth factors might be involved in both bone maintenance and the progression of prostate cancer.

"We believe that this may be why the patients with the highest risk prostate cancer also demonstrated the least loss of BMC as they got older, when compared with patients with non high-risk prostate cancer and no prostate cancer."

The baseline demographics between the three groups of men were similar when it came to their body mass index and smoking history.

The authors believe that this is the first study to explore the relationship between longitudinal BMC measurement and the long-term risk of prostate cancer and, more specifically, life-threatening disease. They point out that the study sample was primarily white (96 per cent) and, due to racial differences in bone density, may not be generally applicable to other ethnic groups.

"We would like to see our theories tested further in larger populations of men at risk of developing life-threatening prostate cancer" concludes Dr Loeb. "If we can better understand the link between prostate cancer and bone, it may help us to find ways of preventing the spread of this disease to bone in the future."

Last edited by gdpawel : 07-08-2012 at 11:18 PM. Reason: post full article
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Old 07-08-2012, 11:19 PM
gdpawel gdpawel is offline
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Default FDA questions benefit of Xgeva (denosumab) in certain cases

The Food and Drug Administration questioned the clinical benefit of using Amgen’s bone drug Xgeva to prevent or delay the spread of prostate cancer to the bones.

Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancers have already spread to the bones.

The company is seeking approval for use of Xgeva to prevent the spread of prostate cancer in a group of men that has not responded to other therapies.

Xgeva will be reviewed Wednesday by the FDA’s oncologic drugs advisory committee, which is made up of non-FDA medical experts. The FDA today posted a review of Xgeva in preparation for the meeting.

Amgen conducted a study of Xgeva in 1432 men with prostate cancer that had not responded to previous therapies, but had not spread to the bones. Many types of cancer spread to the bones and cause tumors to grow, destroying the bone around the tumor, causing fractures and other problems.

Half of the men were treated with Xgeva while the other half received a placebo. The study examined the time until men developed bone metastases or died, whichever occurred first. The study showed Xgeva prolonged median bone metastatis-free survival by 4.2 months compared to men in the placebo group.

While the FDA said the study met its primary objective, the agency said it was unclear whether the results were “clinically meaningful” given that there was no difference in overall survival between the two patient groups. The agency said the risk-benefit ratio of Xgeva must also take into account the overall toxicity of the drug. One of the side-effects includes a risk of developing osteonecrosis of the jaw, or ONJ, a rare jaw-decay problem.

Michael Severino, Amgen’s vice president of research and development, said today that the company believes Xgeva does provide a clinically meaningful benefit because it delays the spread of cancer to the bone, which causes significant pain and other problems such as incontinence.

Xgeva is also sold under the brand name Prolia as an osteoporosis treatment but is administered at a lower dose and less often than used to treat cancer-related bone complications. Xgeva and Prolia’s combined sales in 2011 topped $550 million. The drugs target a protein called RANK Ligand, which helps regulate cells called osteoclasts that break down bone.

Source: Dow Jones Newswires

The Conundrum of Clinically Meaningful Benefit

[url]http://www.medscape.com/viewarticle/805546
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Last edited by gdpawel : 06-16-2013 at 11:09 AM. Reason: additional info
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