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Jiang Yio 2021-05-10 19:01:16 -04:00
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= Bone-directed Therapy
Bisphosphonates or denosumab, a fully humanized anti-RANKL monoclonal antibody, may be approved by the FDA in two situations:
Men receiving long-course ADT in combination with RT for localized prostate cancer who are found to have baseline or treatmentinduced osteopenia or osteoporosis. In this case, the goal is to increase bone mineral density and prevent osteoporosis-related fractures.
Men with mCRPC and bone metastases. In this case, the goal is to prevent SREs. Use of bisphosphonates in mCSPC did not improve SREs or OS in the STAMPEDE trial.
Renal insufficiency, osteonecrosis of the jaw, and hypocalcemia are potential adverse effects of bisphosphonates. Patients with significant dental disease or who require dental procedures should not be treated with bisphosphonates until after dental clearance. Monthly or every 3-month dosing of zoledronic acid is indicated for bone metastases, whereas yearly infusions can be used for treatment of osteoporosis.
In a phase III trial, denosumab, a RANKL inhibitor, was superior to zoledronic acid for prevention of SREs. Hypocalcemia was more common in patients treated with denosumab, and osteonecrosis of the jaw occurred infrequently in both arms.