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Observations From Early Adoption of Radium 223 (Ra-223) in Heavily Pretreated Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
International Journal of Radiation Oncology*Biology*Physics, 1, 90, page S440
Radium 223 dichloride has demonstrated improved survival, decreased probability of skeletal related events, and a positive impact on quality of life assessments in patients with mCRPC. The ALSYMPCA trial did not include routine pain inventories or radiologic assessment. We conducted an IRB approved, retrospective review of our initial experience to analyze patient-reported pain outcomes and imaging response to therapy over a 6 month fractionated course of treatment.
Following FDA approval, from 7/14/13 to 1/29/14, 34 consecutive patients (median: age - 74 yrs (50 - 85 yrs), PSA - 93 (0.1 - 2948)), with symptomatic bone metastases from mCRPC without visceral disease have initiated a 6 infusion course of Ra 223 at 1.35 Ci/kg q 4 weeks. A median of 4 doses delivered. Pain (WHO scale, narcotic use), toxicity (CBC, CTCAE v4.0), and biochemical (PSA, alkaline phosphatase) assessments were made at least every 3 weeks during treatment. Imaging included Tc-99m bone scan.
The majority of patients had received multiple prior therapies for mCRPC (Sipuleucel-t 24%, Docetaxel 59%, Abiraterone 53%, Enzalutamide 53%, Cabezitaxel 26%). The median time since mCRPC is 2 years, with a baseline ECOG PS (0-1 - 59%, ≥ 2 - 41%) and baseline WHO pain scale (0-1 - 44%, 2-3 - 56%). Nine of twenty (45%) potential pts have completed therapy to date. Patient-reported pain responses were observed in 68%, with a median time to response of 3 weeks. Among pts with WHO 2-3, 53% reported a reduction in narcotic use, while 21% discontinued narcotics. Overall, 48% of patients achieved pain-free status during therapy; this was most pronounced among those with WHO score 1 (8 of 12 pts). Among responders, recurrent or new sites of pain during therapy were not uncommon (32%). Bone scans are available for 11 patients without clinical signs of progression (1 PR, 1 mixed, 5 stable, 4 progression). Three pts showed improvement at existing lesions, but with new sites of disease. Safety has been well established previously; we observed gr. 3 neutropenia (1) and thrombocytopenia (1). PSA response >25% was infrequent (12%). Alkaline phosphatase normalization was observed in 36% of pts.
We observed frequent pain responses among heavily pre-treated pts, consistent with phase I/II data that were mostly durable over the course of treatment. Bone scan responses at existing lesions were documented, though some in the context of apparent shifting metastatic disease; serial evaluation is necessary to exclude any influence of flare phenomenom.
Levine Cancer Institute, Carolinas Health System, Charlotte, NC
Author Disclosure: D.R. McHaffie: K. Advisory Board; Algeta. H.J. Sharp: None. J. Symanowski: None. A.J. Crimaldi: None. J. Mahoney: None. E.F. Burgess: None. R. Nazemzadeh: None. M.R. Haake: None.
© 2014 Published by Elsevier B.V.