Isis Gayed, Vivian Salama, Lydia Dawood, Steven Canfield, David Wan, Chunyan Cai, Usha Joseph, Robert Amato

Radium-223 dichloride (Ra-223 Xofigo) has recently been approved as an addition to the host of available therapies in the USA as a treatment option for metastatic castrate-resistant prostate cancer (mCRPC) with bone metastases. This study describes our initial experience in patients treated with Ra-223 dichloride. It attempts to optimize patients' selection for the best outcome from Ra-223 dichloride therapy. Consecutive patients who were referred for treatment with Ra-223 dichloride were prospectively followed. Patients' demographics, functional status per the Eastern Cooperative Oncology Group (ECOG) performance score, pain level per the numeric rating score (NRS), prostate-specific antigen (PSA), creatinine, and hematological values were compared at baseline and at the end of therapy. Patients also had a bone scan before starting therapy and at the end of therapy. Patients were divided into the favorable response (FR) group if their pain and/or functional status improved and the unfavorable response (UR) group if they did not improve, deteriorated, or deceased. Bone scan findings before and after Ra-223 dichloride therapy were compared in both the FR and UR groups. Twenty patients were treated with Ra-223 dichloride. Twelve patients had innumerable bone metastases, three patients had super scans, and three patients had two to seven bone lesions. Two patients were lost to follow-up after the first injection. There were eight patients in the FR group and 10 patients in the UR group. Patients with UR had mean ECOG and NRS pain scores of 1.3 and 5.0 versus 0.8 and 4.4 in the FR group. The mean PSA and creatinine levels in the UR group were 445.2 ng/mL and 1.2 mg/dL versus 22.7 ng/mL and 1.1 mg/dL in the FR group. The mean hemoglobin, platelets, and absolute neutrophil values were 11.2 g/dL, 314.9 K/cmm, and 7.3 K/cmm in the UR group versus 11.6 g/dL, 207.0 K/cmm, and 6.2 K/cmm in the FR group. Seven of the eight patients with FR had a bone scan at the end of therapy showing improvement in five patients, a mixed response in one patient, and progression in another patient. Five patients in the UR group completed five or six injections and had bone scans showing flare of bone metastases in three patients, progression in one patient, and improvement in the fifth patient. Three patients in the UR group died after the first or second injections. Two of these patients had baseline super scans and the third one had widespread bone metastases. mCRPC patients with lower PSA levels at baseline and fewer bone lesions are more likely to respond favorably to Ra-223 dichloride therapy.