124468-142

1.5-year post-treatment follow-up of radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) and bone metastases from the phase 3 ALSYMPCA study.

Subcategory: 
Category: 
Genitourinary Cancer
Session Type and Session Title: 
General Poster Session A: Prostate Cancer
Oral Abstract Session A: Prostate Cancer (eQ&A)
Abstract Number: 
09
Citation: 
J Clin Oncol 32, 2014 (suppl 4; abstr 9)
Author(s): 
Sten Nilsson, Nicholas J. Vogelzang, A. Oliver Sartor, David Bottomley, Robert E. Coleman, Irene Skjorestad, Mona Wahba, Chris Parker; Karolinska University Hospital, Stockholm, Sweden; Comprehensive Cancer Centers of Nevada, Las Vegas, NV; Tulane Cancer Center, New Orleans, LA; St. James Hospital, Leeds, United Kingdom; Weston Park Hospital, Sheffield, United Kingdom; Algeta ASA, Oslo, Norway; Bayer HealthCare, Whippany, NJ; The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: Ra-223 is a first-in-class alpha-emitting pharmaceutical recently Food and Drug Administration approved for treatment (tx) of patients (pts) with CRPC and symptomatic bone metastases (mets). In ALSYMPCA, Ra-223 significantly improved overall survival by 3.6 months versus placebo (pbo) (HR = 0.70; 95% CI, 0.58-0.83; P < 0.001) and was well tolerated. Reported here are long-term safety data ~1.5 years after the last pt’s final injection (inj) from the entire ALSYMPCA safety population. Methods: Eligible pts had progressive CRPC with ≥ 2 symptomatic bone mets and no known visceral mets, were receiving best standard of care, and had received docetaxel or were unfit for or declined docetaxel. Pts were randomized 2:1 to 6 inj of Ra-223 (50 kBq/kg IV; q 4 wk) or matching pbo. Only adverse events (AEs) considered tx related by the investigator were reported during follow-up. Long-term safety data were assessed by specific diseases, including acute myelogenous leukemia, myelodysplastic syndrome, aplastic anemia, primary bone cancer, or primary cancer in other organs. Results: ALSYMPCA safety population included 901 pts (Ra-223, n = 600; pbo, n = 301). Overall, 25 (4%) Ra-223 and 8 (3%) pbo pts had ≥ 1 tx-related AE (Table). During follow-up, primary cancer in other organs was reported in 5 pts (Ra-223, n = 2; pbo, n = 3). Conclusions: Ra-223 is an effective and well-tolerated tx for CRPC with symptomatic bone mets. No major safety issues were identified within ~1.5 years after tx in the ALSYMPCA safety population. Clinical trial information: NCT00699751.

Post-treatment follow-up AE, n (%) Ra-223
n = 600
Placebo
n = 301
All
grades
Grades 3/4 All
grades
Grades 3/4
Hematologic AEs
Anemia 11 (2) 5 (1) 5 (2) 1 (<1)
Aplastic anemia 1 (<1) 1 (<1) 0 0
Leukopenia 2 (<1) 2 (<1) 0 0
Neutropenia 2 (<1) 2 (<1) 0 0
Thrombocytopenia 4 (1) 0 0 0
Nonhematologic AEs
Cardiopulmonary failure 0 0 1(<1)* 0
Nausea 0 0 1 (<1) 0
Fatigue 0 0 1 (<1) 0
General physical health deterioration 1 (<1) 0 0 0
Multiorgan failure 1 (<1)* 0 0 0
Pneumonia 1 (<1)* 0 0 0
Weight decrease 1 (<1) 0 0 0
Anorexia 1 (<1) 0 0 0
Musculoskeletal pain 1 (<1) 0 0 0
Pathologic fracture 2 (<1) 1 (<1) 0 0
Dizziness 1 (<1) 0 0 0

* Grade 5.