Hematologic Safety of Radium-223 Dichloride: Baseline Prognostic Factors Associated With Myelosuppression in the ALSYMPCA Trial

Nicholas J Vogelzang, Robert E Coleman, Jeff M Michalski, Sten Nilsson, Joe M O'Sullivan, Christopher Parker, Anders Widmark, Marcus Thuresson, Lei Xu, Joseph Germino, Oliver Sartor

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Abstract

BACKGROUND: Myelosuppression is common in patients with progressive castration-resistant prostate cancer and bone metastases. Radium-223 prolongs overall survival in these patients but may cause myelosuppression; understanding risk factors will improve clinical decision making. We describe hematologic safety of radium-223 in ALSYMPCA and post hoc analyses identifying patients at increased risk for hematologic toxicity.

PATIENTS AND METHODS: Hematologic parameters and adverse events were analyzed. Multivariate analyses assessing baseline risk factors for hematologic toxicities were performed separately for radium-223 and placebo patients.

RESULTS: Nine hundred one patients received radium-223 (n = 600) or placebo (n = 301); 65% of radium-223 and 48% of placebo patients had the full 6 cycles. Grade 3/4 thrombocytopenia was more common in radium-223 versus placebo patients (6% vs. 2%). Logistic regression analyses identified significant baseline predictors for grade 2-4 hematologic toxicities related to radium-223 treatment: extent of disease (6-20 vs. < 6 bone metastases; odds ratio [OR] = 2.76; P = .022) and elevated prostate-specific antigen (OR = 1.65; P = .006) for anemia; prior docetaxel (OR = 2.16; P = .035), decreased hemoglobin (OR = 1.35; P = .008), and decreased platelets (OR = 1.44; P = .030) for thrombocytopenia. Neutropenia events were too few in placebo patients for a comparative analysis. There were no significant associations between hematologic toxicities and number of radium-223 injections received (4-6 vs. 1-3).

CONCLUSION: Radium-223 has a favorable safety profile with a low myelosuppression incidence. Understanding baseline factors associated with myelosuppression may assist clinicians in avoiding severe myelosuppression events with radium-223.

Original languageEnglish
Pages (from-to)42-52.e8
JournalClinical genitourinary cancer
Volume15
Issue number1
Early online date08 Aug 2016
DOIs
Publication statusPublished - Feb 2017

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    Vogelzang, N. J., Coleman, R. E., Michalski, J. M., Nilsson, S., O'Sullivan, J. M., Parker, C., Widmark, A., Thuresson, M., Xu, L., Germino, J., & Sartor, O. (2017). Hematologic Safety of Radium-223 Dichloride: Baseline Prognostic Factors Associated With Myelosuppression in the ALSYMPCA Trial. Clinical genitourinary cancer, 15(1), 42-52.e8. https://doi.org/10.1016/j.clgc.2016.07.027