Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone).

Amgen is studying denosumab in numerous tumor types across the spectrum of cancer induced bone disease.

Such were the findings recently reported by Amgen, Inc –maker of the bone loss drug denosumab.

In this study of more than 1,400 men, denosumab treatment produced statistically significantly greater increases in bone mineral density (BMD) at the lumbar spine (primary endpoint) and non-vertebral sites compared with placebo at multiple time points. These improvements in BMD were consistent with those seen in other denosumab studies evaluating BMD in women with breast cancer receiving aromatase inhibitor therapy, and in post-menopausal women with low bone mass.

During the 36-month evaluation period, men receiving denosumab experienced less than half the incidence of new vertebral fractures (a secondary endpoint) compared with those receiving placebo, a statistically significant finding. Furthermore, in the denosumab arm there were fewer non-vertebral fractures over the 36-month period.

Loss in bone mineral density and fractures are conditions induced by the hormone-blocking therapy that men with non-metastatic prostate cancer has to go through.

While this bone loss drug could be the answer to that problem…I’m pretty sure it has side-effects. Let’s wait and see what the FDA has to say. This is a Phase 3 clinical trial already, so that means it won’t be long until this gets approved for marketing and use in patients. We’ll see…

Post from: Blisstree

Amgen’s Bone Loss Drug and Prostate Cancer

Apparently, men who are undergoing anti-hormonal treatment or androgen-deprivation therapy as treatment for prostate cancer, experience hot flashes as well.

The only current therapeutic agents for this condition are androgen-originating hormones. However, some of which can actually fuel the growth of cancer. Men may be relieved of hot flashes but new cancer growth becomes an issue to worry about.

Now, according to North Central Cancer Treatment Group researchers (based at Mayo Clinic in Rochester, Minn.), low doses of the drug gabapentin can reduce hot flashes in this patient population of men.

…the drug gabapentin reduced the frequency and the intensity of hot flashes by up to 46 percent in men receiving androgen deprivation therapy.

The men who received gabapentin reported fewer side effects than those receiving a placebo tablet.

Gabapentin is being used to prevent epileptic seizures and to treat nerve pain caused by shingles.

According to the study’s lead investigator, Mayo Clinic oncologist Charles Loprinzi, M.D.:

“To my knowledge, this is the first nonhormonal treatment of hot flashes in men, where results from a placebo-controlled trial are positive enough to support that a nonhormonal medication can be used to help some of our patients.

Because gabapentin works on the central nervous system, its function may be similar to some antidepressants that are prescribed to reduce hot flashes in women entering menopause.

This [gabapentin] provides an immediate clinical option that has not been previously available for treatment of hot flash side effects, and it is a welcome one.”

The findings, presented at the recent annual meeting of the American Society of Clinical Oncology in Chicago, came from the 223-patient, placebo-controlled Phase III clinical trial on gabapentin.

Approved by the FDA to treat epileptic seizures in 1994 and pain from shingles in 2002, gabapentin is marketed by Pfizer under the trade name Neurontin®.

Find more details from the Mayo Clinic full report.

Post from: Blisstree

Pfizer’s Neurontin® (gabapentin): Can Reduce Hot Flashes in Men on Prostate Cancer Treatment

ADT works by blocking the level of circulating androgens (male hormones) – the ones that can fuel the growth of prostate cancers.

According to a research team from Dana-Farber Cancer Institute, Brigham and Women’s Hospital and other institutions, ADT may increase the risk of death from heart disease mortality in prostate cancer patients above age 65.

Such findings have been reported at the recent Prostate Cancer Symposium- sponsored by the American Society of Clinical Oncology, the American Society for Therapeutic Radiology and Oncology and the Society of Urologic Oncology – in Orlando, Florida.

According to the study’s lead author, Henry Tsai, MD, a resident physician at Dana-Farber, Brigham and Women’s and the Harvard Radiation Oncology Program:

“Androgen deprivation therapy is associated with elevated body mass index, increased body fat deposits and diabetes, all of which raise the risk of death from heart diseases.”

Findings of this study should help oncologist in weighing the benefits of ADT and the risk of heart disease before administering to elderly prostate cancer patients.

Find more details from the full report.

Post from: Blisstree

Androgen Deprivation Therapy in Prostate Cancer Increases Risk of Death from Heart Disease in Older Men

Prostate cancer patients treated with either radiation or surgery who use hormone therapy for longer than six months do not survive any longer than patients who use the treatment for a shorter amount of time.

Most high risk prostate cancer patients are currently being treated with two or more years of hormone therapy based on a decade-old study results.

The new findings, headed by Cliff Robinson, M.D., lead author of the study and a radiation oncologist at Cleveland Clinic in Cleveland, Ohio, suggest that treating current patients with shorter-term hormone therapy may not only be equally effective, but also improve their quality of life, because of a lesser degree of treatment side effects.

Androgen deprivation therapy is a hormone therapy used to treat prostate cancer by lowering the level of male hormones (androgens) to shrink or slow down the growth of prostate cancer.

The new study also found that patients receiving longer than six months of hormone therapy were twice as likely to die as patients who use the treatment for a shorter amount of time.

According to Dr. Robinson:

“The reasons why patients receiving longer term hormone therapy may do worse are unclear. A number of factors could complicate the issue, and this area needs further investigation before any conclusions can be drawn.”

Find more details from the ASTRO press release.

Post from: Blisstree

Prostate Cancer Patients on Longer Hormone Therapy Don’t Necessarily Live Longer, Study Finds