Xgeva Cancer Treatment for Bone Metastases

Xgeva (Denosumab) is an FDA approved cancer treatment to help prevent fractures and other cancer related bone problems in adults who have advanced cancer that has metastasized, meaning it has spread, to their bones.

When a patient’s cancer has spread to their bones, bone fractures may be painful and may often not heal properly. These fractures may often occur in the ribs, spine, pelvis and thigh bone. Fractures within bones that require a lot of weight bearing, such a s the spine or thigh, often require surgery.

Xgeva is a monoclonal antibody, which is a type of biological therapy, designed in the laboratory. It is basically a man made version of an immune system protein. These antibodies target and find specific cancer cells, while protecting healthy cells from damage. As a treatment, Xgeva seeks to prevent the cancer from destroying bone tissue.

How Xgeva Works
Referred to as targeted therapy, Xgeva targets a particular protein called RNK ligand (RANKL), which affects the activity of osteoclast cells; a bone cell that breaks down bone tissue, which is critical to the maintenance and repair of our bones, including regulating calcium levels.
There are different phases of a clinical trial to help determine the treatment drug dose, safety and its effectiveness.

RNKL normally signal the osteoclast cells to break down bone, but when Xgeva targets and binds to this protein, this action is blocked. Xgeva is called a RANKL inhibitor. By inhibiting the RNKL cells, the activity of the osteoclast cells slow down, allowing this treatment to help strengthen the bones, so that they don’t hurt, break or cause high levels of calcium in the blood.

For women who have been diagnosed with breast cancer that has spread to their bones, the osteoclast cells maybe be overactive, which can lead to both bone pain and bone destruction. By reducing the osteoclast activity, Xgeva can help reduce the pain, as well as the risk of bone problems. Besides breast cancer, Xgeva is also used for other types of solid cancers that have spread to the bones, such as lung, prostate, stomach, kidney cancer and lymphoma.

Solid cancers are abnormal cellular growths that form solid tumors that are not made up of fluid areas or cysts, such as with breast or lung cancer, as opposed to a cancer that affects the blood, such as leukemia, which is a liquid.

Developed by Amgen, Xgeva is given by an injection in the upper arm, upper thigh, or stomach once a month for as long as it is working or until a severe side effect occurs.

Common Side Effects

  • Fatigue or Weakness

  • Nausea, vomiting or loss of appetite

  • Diarrhea or constipation

  • Bone, joint or muscle pain that is sometimes severe

  • Headaches or back pain

Less Common, More Serious Side Effects

  • Shortness of breath

  • Low calcium levels in the blood

  • Allergic reaction

  • Atypical femoral fracture

  • Osteonecrosis of the jaw. This is damage to the jaw bone, as the treatment may cause bone loss to the jaw, which may include symptoms such as jaw pain or numbness, swollen gums, loose teeth, gum infection or delayed healing following dental work.

As with any type of cancer treatment, there will be certain side effects from this treatment. Your health care team will go over possible side effects, but be sure to alert them to any discomfort you may experience during your treatment.

Precautions to Prevent Side Effects
Because of osteonecrosis of the jaw, a dental exam should be performed prior to treatment. Also patients with pre-existing hypocalcemia (having an electrolyte imbalance) and/or vitamin D deficiency should be corrected prior to treatment.

Patients should be counseled regarding adequate intake of calcium and vitamin D during therapy

For daily calcium intake, it is recommended that women and men should consume the following amounts:
– Calcium: 1000 to 1200 mg/day
– Vitamin D: 800 to 1000 units/day

Other Considerations
Patients with renal impairment (CrCl <30 mL/minute) or patients on dialysis should use caution with this treatment.

This treatment is not approved for use for people with bone marrow cancer – multiple myeloma.

Pregnancy Precautions
Xgeva may cause fetal harm if administered to a pregnant woman. Women should also not become pregnant during their treatment with Xgeva.

Patients with advanced cancers that have spread to their bones may benefit from this treatment, which may play an important role in reducing the incidence of bone fractures and other complications of the bones.