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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.
Oral Abstract Session A: Prostate Cancer (eQ&A)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
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
n = 301
|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|
|General physical health deterioration||1 (<1)||0||0||0|
|Multiorgan failure||1 (<1)*||0||0||0|
|Weight decrease||1 (<1)||0||0||0|
|Musculoskeletal pain||1 (<1)||0||0||0|
|Pathologic fracture||2 (<1)||1 (<1)||0||0|
* Grade 5.
Abstracts by Sten Nilsson:
Analysis of overall survival by number of radium-223 injections received in an international expanded access program (iEAP).Meeting: 2016 ASCO Annual Meeting | Abstract No: 5082
Validation of a 3-gene signature and development of an authentic cohort database to improve overall survival prediction and clinical treatment decision for patients with newly diagnosed prostate cancer.Meeting: 2016 ASCO Annual Meeting | Abstract No: 5047
3-year safety follow-up of radium-223 dichloride (Ra-223) in patients (Pts) with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases (Mets) from ALSYMPCA.Meeting: 2015 Genitourinary Cancers Symposium | Abstract No: 195