Prolia Approved for Treatment of Bone Loss in Patients with Breast or Prostate Cancer

The U.S. Food and Drug Administration (FDA) has expanded the approval of Prolia® (denosumab) to include treatment of bone loss among breast cancer patients treated with aromatase inhibitor therapy and prostate cancer patients treated with androgen deprivation therapy for non-metastatic cancer. Treatment is intended to increase bone mass among patients at high risk of fracture.
Osteoporosis affects an estimated 10 million Americans over the age of 50. Each year, roughly 1.5 million Americans will experience an osteoporosis-related bone fracture.[1] These fractures commonly involve the wrist, hip, or spine, but can affect any part of the body.
Bone loss accelerates as we age (with particularly rapid loss in women after menopause), but can also be caused by certain types of cancer treatment. Hormonal therapies such as aromatase inhibitors for breast cancer and androgen-deprivation therapy for prostate cancer, for example, are known to cause bone loss. Bone loss from cancer treatment tends to be more rapid and severe than the bone loss that occurs naturally with aging.[2]
Prolia targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Prolia has been shown to reduce the risk of fractures in high-risk postmenopausal women with osteoporosis, and was approved for this purpose in 2010.
Studies have also now shown that Prolia is effective against cancer treatment-induced bone loss. In a study of men undergoing androgen-deprivation therapy for non-metastatic prostate cancer, those who received Prolia were 62% less likely to develop a new vertebral fracture than those who received a placebo.[3] Prolia has also been found to improve or maintain bone density among women undergoing aromatase inhibitor treatment for breast cancer.[4] The most common side effects of Prolia were joint and back pain.
Prolia is the first drug approved for cancer treatment-induced bone loss.
References:

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[1] U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General, 2004. [2] Body JJ. Prevention and treatment of side-effects of systemic treatment: bone loss. Annals of Oncology. 2010; 21(supplement 7):vii180-vii185.
[3] Smith MR, Egerdie B, Hernandez Toriz N et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. New England Journal of Medicine. Early online publication August 11, 2009.
[4] Ellis GK, Bone HG, Chlebowski R et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. Journal of Clinical Oncology. 2008;26:4875-4882.

Regular Use of Nonaspirin NSAIDs May Increase Kidney Cancer Risk

Long-term users of nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) may have an increased risk of developing renal cell (kidney) cancer. These findings were recently reported in the Archives of Internal Medicine.
Nonsteroidal anti-inflammatory drugs are used to reduce inflammation and pain; they include drugs such as aspirin and ibuprofen. Some studies have suggested that NSAIDs may reduce the risk of certain types of cancer, such as colorectal cancer, breast cancer, and prostate cancer. When it comes to kidney cancer, however, some data have shown that NSAIDs may increase rather than reduce risk.
To further investigate the link between NSAID use and kidney cancer, researchers tracked aspirin, nonaspirin NSAID, and acetaminophen (also a pain reliever) use among 77,525 women and 49,403 men participating in the Nurses’ Health Study and the Health Professionals Follow-Up Study. Data were collected beginning in1990 for the Nurses’ Health Study and in 1986 for the Health Professionals Follow-Up Study and again every two years through follow-up at 16 and 20 years, respectively.

• 333 cases of kidney cancer were diagnosed among participants in both studies combined.
• Regular use of nonaspirin NSAIDs appeared to increase risk of kidney cancer, with an increase in relative risk of 51%.
• Regular use of aspirin and acetaminophen did not appear to increase risk of kidney cancer.
• Longer use of nonaspirin NSAIDs was associated with increasing risk of kidney cancer: Use for less than four years was associated with a 19% decreased relative risk of developing kidney cancer, whereas use from four to 10 years was associated with a 36% increased relative risk and use for 10 years or more with an almost threefold increase in relative risk.

The researchers conclude that because regular use of nonaspirin NSAIDs may increase risk of developing kidney cancer, “Risks and benefits should be considered in deciding whether to use [pain relievers].” Regular nonaspirin NSAID users may want to be especially aware of the risks and benefits, given the increased risk associated with long-term use.
Reference: Cho E, Curhan G, Hankinson SE, et al. Prospective evaluation of analgesic use and risk of renal cell cancer. Archives of Internal Medicine. 2011;171(16):1487-1493. doi:10.1001/archinternmed.2011.356.