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Update on Denosumab for Prevention of SREs

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Back in April I reviewed the use of Aredia, Zometa, and denosumab for the prevention of skeletal-related events (SREs), in patients with cancer with bony metastases. SREs, defined as pain or fracture in a bone from cancer involvement, can result in the need for radiation, surgery, or other intervention, and consequently is damaging to the quality of life of patients with advanced cancer.

At that time, denosumab had been studied primarily in the treatment of osteoporosis, although a number of trials were ongoing in cancer patients. The only published large randomized trial in cancer patients at that time compared denosumab to placebo in women with surgically-resected breast cancer who were receiving endocrine therapy. Denosumab or placebo was administered every 6 months, with the outcomes of measuring an increase in bone density. Denosumab was shown to be better than placebo at increasing bone density. Measurement of SREs was not the goal of this trial.

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Overview of Bone Metastases and Bisphosphonate Treatment

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A query was recently raised about the use of denosumab for the treatment of bony metastases from lung cancer. We’ll cover what is known about that newer agent for bone metastases, but first let’s set the stage with a general discussion of the topic and the management options we’ve generally pursued over the past few years.

To put things into context, when a cancer spreads to bones, the chief concerns are that the tumors can cause pain, as well as a risk of fracture in those bones. Depending on the location of the bones involved, fractures can have consequences beyond just the pain. For example, a break in a hip bone may require surgery in order to help a patient maintain the ability to walk, etc.

With lung cancer, for large bone metastases that are already symptomatic or at risk of breaking, generally the first treatment of choice is radiation to that area. This can help to relieve pain, and to strengthen the bone and decrease the risk of the bone breaking. If a bone in a weight-bearing area (the upper arms and legs in particular) has broken or is at too high of a risk for breaking, surgery may be required to stabilize that region.

Chemotherapy can also help to decrease the symptoms from bone metastases by treating the cancer cells directly, while at the same time treating cancer cells wherever else they may be located in the body.

Questions have been raised however about what to do with cancers that have spread to many different bone locations, or who have small bone metastases that do not require radiation. These patients may be at risk for pain or fracture in the future, but not necessarily immediately. Is there anything that can be done to decrease that risk of developing pain? Can the risk of fracture (which by the nature of a risk, may or may not happen), be reduced or delayed?

Such an event (pain or bone fracture) in the medical literature is termed a skeletal-related event, or SRE for short.

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