The study is designed to determine if the addition of a radiopharmaceutical to bisphosphonates for patients with asymptomatic or stable symptomatic bone metastasis will delay the time to development of malignant skeletal related events (SREs), defined as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone. It is expected to involve approximately 350 patients.
“Bone pain palliation is critical for cancer patients afflicted with metastatic bone disease, yet radiopharmaceuticals remain underutilized in such settings,” said Michael Becker, president and CEO of Cytogen. “With more than a dozen company and government-sponsored clinical studies underway or in planning, we are demonstrating our commitment to optimize radiopharmaceutical therapy for pain palliation, increase its awareness among oncologists, and contribute effectively to patient palliation and quality-of-life improvements.”
Each year, more than 100,000 patients in the US develop bone metastases from spread of their primary cancer. Bone is the third most common site of metastatic disease after liver and lung, and spread to bone is associated with considerable morbidity. Furthermore, the incidence of bone metastasis is expected to increase over the next decade as patient survival improves due to advances in anticancer therapy.