eRADicAte: A Prospective Evaluation Combining Radium-223 Dichloride and Abiraterone Acetate Plus Prednisone in Patients With Castration-Resistant Prostate Cancer.

Autor: Shore ND; Carolina Urologic Research Center, Myrtle Beach, SC. Electronic address: nshore@gsuro.com., Tutrone RF; Chesapeake Urology Research Associates, Towson, MD., Mariados NF; Associated Medical Professionals of New York, Syracuse, NY., Nordquist LT; GU Research Network, Omaha, NE., Mehlhaff BA; Oregon Urology Institute, Springfield, OR., Steere KJ; Steere and Associates, LLC, St Paul, MN., Harrelson SS; Carolina Urologic Research Center, Myrtle Beach, SC.
Jazyk: angličtina
Zdroj: Clinical genitourinary cancer [Clin Genitourin Cancer] 2018 Apr; Vol. 16 (2), pp. 149-154. Date of Electronic Publication: 2017 Nov 07.
DOI: 10.1016/j.clgc.2017.10.022
Abstrakt: Background: Multiple castration-resistant prostate cancer (CRPC) therapies are approved by the United States Food and Drug Administration. Radium-223 dichloride (Ra-223) with abiraterone acetate plus prednisone have different mechanisms of action and distinct off-target side-effect profiles. We prospectively investigated their combined safety, tolerability, and patient-reported outcome measures.
Patients and Methods: eRADicAte, an investigator-initiated, phase II trial, studied 31 patients with metastatic CRPC, from 5 United States uro-oncology research sites. Patients completed 6 cycles of Ra-223 with concurrent abiraterone therapy. Quality of life and pain were assessed using the Functional Assessment of Cancer Therapy-Prostate and the Brief Pain Inventory-Short Form questionnaires and their subscales; we reported the number of subjects meeting standardized criteria for clinically meaningful improvements on each scale. Safety assessment included Eastern Cooperative Oncology Group performance status, laboratory changes, opioid use, radiographic responses, and adverse events (AEs).
Results: Twenty of 31 (65%) experienced positive clinically meaningful improvement changes on the Functional Assessment of Cancer Therapy-Prostate, and 25 (81%) of 31 on the Prostate Cancer Subscale. Eighteen (58%) of 31 demonstrated reduced pain intensity and 12 (39%) of 31 demonstrated reduction of pain interference in their lives. At baseline, subjects averaged 11.6 ± 2.8 bone lesions; at the end of treatment, subjects averaged 5.6 ± 2.4 bone lesions (P = .0002). The most frequent AEs were diarrhea (17%), nausea (17%), and fatigue (14%). There were 6 serious AEs; 1 led to study withdrawal.
Conclusions: Patients experienced clinically meaningful improvements in quality of life and pain, without unexpected adverse toxicities. Phase III combination trials of Ra-223 with novel oral hormonal agents are ongoing to further evaluate radiographic progression and overall survival benefit.
(Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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