OBJECTIVE: To review and evaluate the clinical trial efficacy and safety of radium 223 (223Ra) along with its place in therapy in men with castration-resistant prostate cancer (CRPC).
DATA SOURCES: A literature search in PubMed/MEDLINE (up to October 2014) was performed using various combinations of the terms radium, hormone-refractory prostate cancer, and castration-resistant prostate cancer. The New Drug Application Medical, Pharmacology, and Clinical Pharmacology and Biopharmaceutics Reviews for radium 223Ra dichloride were also utilized. The bibliographies of articles were reviewed to identify additional references.
STUDY SELECTION AND DATA EXTRACTION: Phase 1, 2, and 3 studies that assessed the safety and/or efficacy of 223Ra in patients with CRPC were reviewed. Peer-reviewed articles with clinically relevant information were reviewed for background information.
DATA SYNTHESIS: In May 2013, the Food and Drug Administration approved intravenous use of 223Ra for the treatment of patients with CRPC, symptomatic bone metastases, and no known visceral metastatic disease. In a phase 3 study comparing 223Ra and the best standard of care (SOC) versus the best SOC plus placebo, 223Ra was shown to increase survival. The most commonly seen adverse drug reactions and hematological laboratory abnormalities with 223Ra include nausea, diarrhea, vomiting, peripheral edema, anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.
CONCLUSIONS: 223Ra is a first-in-class α-particle-emitting radioactive agent that is first-line therapy, providing an extra option for men suffering from CRPC with symptomatic bone metastases and no known visceral metastases. 223Ra has also been shown to be relatively well tolerated when up to 6 injections are given. Further studies are needed to evaluate whether 223Ra is safe and effective for more than 6 doses and if it can be used concomitantly with chemotherapy.
Written by:
McGann S, Horton ER. Are you the author?
MCPHS University, Boston, MA, USA; Genzyme, A Sanofi Company, Cambridge, MA, USA.
Reference: Ann Pharmacother. 2015 Jan 8. pii: 1060028014565444.
doi: 10.1177/1060028014565444
PubMed Abstract
PMID: 25573268