title: Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial.
abstract: Symptomatic skeletal events (SSEs) commonly occur in patients with bone metastases, often leading to hospitalisations and decreased quality-of-life. In the ALSYMPCA trial, radium-223 significantly improved overall survival (hazard ratio 0.70, 95% confidence interval [CI] 0.58-0.83, P < 0.001) and prolonged time to first SSE (hazard ratio 0.66, 95% CI 0.52-0.83, P = 0.00037) and subsequent SSE (hazard ratio 0.65, 95% CI 0.51-0.83, P = 0.00039) versus placebo in patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases. Health care resource use (HCRU), including hospitalisation events and days, were prospectively collected in ALSYMPCA. We assessed health care resource use for the first 12 months post-randomisation. Significantly fewer radium-223 (218/589; 37.0%) versus placebo patients (133/292; 45.5%) had at least one hospitalisation event (P = 0.016). However, mean number of hospitalisation events per patient was similar (radium-223 0.69 versus placebo 0.79, P = 0.226), likely due to the significantly longer follow-up time for radium-223 (7.82 months versus 6.92 months for placebo; P < 0.001). There were significantly fewer hospitalisation days per patient for radium-223 (4.44 versus 6.68, respectively, P = 0.004). The reduction in hospitalisation days with radium-223 was observed both before first SSE (2.35 days versus 3.36 days, respectively) and after SSE (7.74 days versus 9.19 days, respectively). Our data suggest that this reduced hospital days along with the survival benefit and reduction in time to SSEs with radium-223 treatment may contribute to improvements in health-related quality-of-life in patients with castration-resistant prostate cancer with symptomatic bone metastases (ALSYMPCA ClinicalTrials.gov number, NCT00699751.).
authors.affiliation: The Royal Marsden Hospital, Downs Road, Sutton, Surrey, SM2 5PT, UK. Electronic address: chris.parker@rmh.nhs.uk.
authors.forename: Christopher
authors.initials: C
authors.lastname: Parker
authors.affiliation: Bayer HealthCare Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ 07981, USA.
authors.forename: Lin
authors.initials: L
authors.lastname: Zhan
authors.affiliation: Bayer HealthCare Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ 07981, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Cislo
authors.affiliation: Yale University, New Haven, CT 06520, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Reuning-Scherer
authors.affiliation: Comprehensive Cancer Center of Nevada, 3730 South Eastern Avenue, Las Vegas, NV 89169, USA.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Vogelzang
authors.affiliation: Karolinska University Hospital, SE-171 76, Stockholm, Sweden.
authors.forename: Sten
authors.initials: S
authors.lastname: Nilsson
authors.affiliation: Tulane Cancer Center, 150 South Liberty Street, New Orleans, LA 70112, USA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Sartor
authors.affiliation: Centre for Cancer Research and Cell Biology, Queen's University, Belfast, UK.
authors.forename: Joe M
authors.initials: JM
authors.lastname: O'Sullivan
authors.affiliation: Weston Park Hospital, Sheffield, UK.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Coleman
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary*; D004311:Double-Blind Method; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy*; D011868:Radioisotopes / Q000627:therapeutic use; D019275:Radiopharmaceuticals / Q000627:therapeutic use; D011883:Radium / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D011868:Radioisotopes; D019275:Radiopharmaceuticals; C581106:radium Ra 223 dichloride; D011883:Radium
keywords: Health care resource use; Hospitalisation; Metastatic castration-resistant prostate cancer (mCRPC); Radium-223; Symptomatic skeletal event