CHICAGO, IL USA (UroToday.com) - Presented by Nicholas Vogelzang, MD at the American Society of Clinical Oncology (ASCO) Annual Meeting - May 31 - June 4, 2013 - McCormick Place - Chicago, IL USA
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ABSTRACT:
Efficacy and safety of radium-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patients with bone metastases who did or did not receive prior docetaxel (D) in the phase III ALSYMPCA trial
Nicholas J. Vogelzang, Svein Inge Helle, Dag Clement Johannessen, Joe M. O’Sullivan, Jose E. Garcia-Vargas, C. Gillies O’Bryan-Tear, Minghua Shan, Chris Parker
Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Haukeland University Hospital, Bergen, Norway; Ullevål University Hospital, Oslo, Norway; Centre for Cancer Research and Cell Biology, Queen’s University, Belfast, Ireland; Bayer HealthCare Pharmaceuticals, Montville, NJ; Algeta ASA, Oslo, Norway; The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom
Background: Ra-223, a first-in-class a-emitter, significantly improved median overall survival (OS) by 3.6 mo vs placebo (Pbo) in CRPC patients (pts) with bone metastases (mets) receiving best standard of care (BSoC) in the ALSYMPCA study (HR = 0.695; 95% CI, 0.581-0.832; p = 0.00007), and had a highly favorable safety profile in the updated ALSYMPCA analysis (Parker et al. ASCO 2012). This predefined subgroup analysis assessed efficacy and safety of Ra-223 in pts who did or did not receive prior D (pD).
Methods: Eligible pts had progressive, symptomatic CRPC with ≥ 2 bone mets; had no known visceral mets; were receiving BSoC; and had received pD, or were unfit for or declined D (npD). Pts were randomized 2:1 to 6 injections of Ra-223 (50 kBq/kg IV) q4wk or matching Pbo and stratified by prior D use, baseline alkaline phosphatase level, and current bisphosphonate use. Survival data were compared using a log-rank test.
Results: 395/921 (43%) randomized pts had npD (Ra-223, n = 262; Pbo, n = 133); 526/921 (57%) received pD (Ra-223, n = 352; Pbo, n = 174). Median ages were 74 y (npD) and 69 y (pD). In pts with npD, median OS was 16.1 mo in the Ra-223 group vs 11.5 mo in the Pbo group (HR = 0.745; 95% CI, 0.562-0.987; p = 0.039). In pts with pD, median OS was 14.4 mo vs 11.3 mo in the Ra-223 and Pbo groups, respectively (HR 5 0.710; 95% CI, 0.565-0.891; p = 0.003). Overall, there was a low incidence of myelosuppression. Incidences of neutropenia and thrombocytopenia were higher in pts with pD vs pts with npD.
Conclusions: Ra-223 significantly prolonged OS and had a highly favorable safety profile in CRPC pts with bone mets, regardless of whether they had pD or npD. pD pts had a slightly increased rate of grade 3 and 4 bone marrow suppression with Ra-223. Clinical trial information: NCT00699751.
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Nicholas Vogelzang, MD was trained in GU oncology, and particularly testis cancer, at the University of Minnesota from 1978-1982. He was appointed as the first full-time genitourinary medical oncology investigator at the University of Chicago and was Director of GU Oncology from 1982 to 1999. He was also the founding chair of the Prostate/GU committee of the CALGB from 1992-99. In 1999 he became the Fred C. Buffett Professor of Medicine and Chair in Genitourinary Oncology as well as Director of the University of Chicago Cancer Research Center (UCCRC). Upon moving to become the Director of the Nevada Cancer Institute (2004-2009) he set up the first phase GU program in the state of Nevada recruiting Drs. Oscar Goodman and Wolf Samlowski. In 2009, he (and later Drs Goodman and Samlowski) joined the Comprehensive Cancer Centers of NV (a US Oncology Affiliate). He is now co-chair of GU Oncology for US Oncology, chairs the Developmental Therapeutics Comm and sits on the Research Executive Committee.
He remains involved in SWOG as the vice chair of the GU Committee, in translational research (most recently on circulating tumor cells) and performs and leads Phase I, II and III trials for both US Oncology and pharma. Although primarily focused on prostate and kidney cancer clinical trials, he has authored numerous publications in bladder cancer. He currently is the PI of the US Oncology Research network for a randomized phase 2 trial of gemcitabine/cisplatin +/- eribulin.
