One-Year Postapproval Clinical Experience with Radium-223 Dichloride in Patients with Metastatic Castrate-Resistant Prostate Cancer.

OBJECTIVES: We report our 1-year postapproval clinical experience with Radium-223 dichloride for treatment of castrate-resistant prostate cancer with bone metastases.

METHODS: The clinical courses of the first 25 patients treated were reviewed retrospectively. Incidence of hematologic, gastrointestinal, and other adverse events were identified, including those events that led to cessation or delay in treatment. Alterations in bone pain and serum alkaline phosphatase and prostate-specific antigen (PSA) levels were evaluated.

RESULTS: Six patients received all 6 scheduled doses of Radium-223 dichloride, 2 completed 5 doses, 6 received 4 doses, 2 completed 3 doses, 6 patients had 2 doses, and 3 patients received one dose, for a total of 91 doses administered. Nine patients discontinued treatment after receiving at least one dose due to progressive disease, 5 required blood transfusions, 5 developed gastrointestinal symptoms, 4 reported worsening bone pain, and 1 developed dermatitis. Downward trends in serum alkaline phosphatase and PSA were seen in 11 and 5 patients, respectively.

CONCLUSIONS: About one-quarter of cohort completed the entire six-dose treatment. Advancing soft tissue disease was the primary reason for cessation of therapy. The adverse events were mild and manageable. A decline in serum alkaline phosphatase was more common than a decline in PSA.