PMID- 23021204
OWN - NLM
STAT- MEDLINE
DCOM- 20130805
LR  - 20220321
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 11
IP  - 1
DP  - 2013 Mar
TI  - Two-year survival follow-up of the randomized, double-blind, placebo-controlled 
      phase II study of radium-223 chloride in patients with castration-resistant 
      prostate cancer and bone metastases.
PG  - 20-6
LID - S1558-7673(12)00168-1 [pii]
LID - 10.1016/j.clgc.2012.07.002 [doi]
AB  - BACKGROUND: This phase II randomized, placebo-controlled study was conducted to 
      evaluate efficacy and safety of radium-223 in patients with castration-resistant 
      prostate cancer (CRPC) and painful bone metastases. Twelve- and 18-month survival 
      results were reported previously. Here we report 24-month overall survival (OS) 
      and safety data from the period 12 to 24 months after the first injection of 
      study medication. METHODS: Patients with CRPC and bone pain were randomized 1:1 
      to receive 4 injections of radium-223 (50 kBq/kg [n = 33]) or placebo (n = 31) 
      after external-beam radiotherapy; each injection was given every 4 weeks. 
      Endpoints for this report were 24-month OS, long-term safety, and 
      treatment-related adverse events (AEs) occurring in the 12- to 24-month period. 
      RESULTS: After 24 months, 10 (30%) patients were alive in the radium-223 group 
      compared with 4 patients (13%) in the placebo group. Patients who received at 
      least 1 dose of study medication had a median OS of 65 weeks in the radium-223 
      group vs. 46 weeks in the placebo group (log-rank P = .056). The hazard ratio 
      (HR) for OS, adjusted for baseline covariates, was 0.476 (95% confidence interval 
      [CI], 0.258-0.877; Cox regression P = .017). The most frequent cause of death for 
      both arms was disease progression. There were no reports of treatment-related AEs 
      or long-term hematologic toxicity during the 12- to 24-month follow-up. 
      CONCLUSION: Radium-223 had a highly favorable safety profile, with no evidence of 
      second malignancies at 24-month follow-up. The significant improvement in OS 
      observed in patients receiving radium-223 vs. placebo suggests that treatment of 
      bone disease with radium-223 has survival benefits.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Nilsson, Sten
AU  - Nilsson S
AD  - Karolinska University Hospital, Stockholm, Sweden. sten.nilsson@ki.se
FAU - Franzen, Lars
AU  - Franzen L
FAU - Parker, Christopher
AU  - Parker C
FAU - Tyrrell, Christopher
AU  - Tyrrell C
FAU - Blom, Rene
AU  - Blom R
FAU - Tennvall, Jan
AU  - Tennvall J
FAU - Lennernas, Bo
AU  - Lennernas B
FAU - Petersson, Ulf
AU  - Petersson U
FAU - Johannessen, Dag C
AU  - Johannessen DC
FAU - Sokal, Michael
AU  - Sokal M
FAU - Pigott, Katharine
AU  - Pigott K
FAU - O'Bryan-Tear, Charles Gillies
AU  - O'Bryan-Tear CG
FAU - Thuresson, Marcus
AU  - Thuresson M
FAU - Bolstad, Bjorg
AU  - Bolstad B
FAU - Bruland, Oyvind S
AU  - Bruland OS
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120926
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 0 (Radioisotopes)
RN  - 0 (Radiopharmaceuticals)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - RJ00KV3VTG (radium Ra 223 dichloride)
RN  - W90AYD6R3Q (Radium)
SB  - IM
MH  - Adenocarcinoma/mortality/*radiotherapy/secondary
MH  - Aged
MH  - Aged, 80 and over
MH  - Bone Neoplasms/mortality/*radiotherapy/secondary
MH  - Clinical Trials, Phase II as Topic
MH  - Combined Modality Therapy
MH  - Docetaxel
MH  - Double-Blind Method
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Management
MH  - *Palliative Care
MH  - Proportional Hazards Models
MH  - Prostatic Neoplasms/mortality/pathology/*radiotherapy
MH  - Radioisotopes/administration & dosage
MH  - Radiopharmaceuticals/*administration & dosage
MH  - Radium/*administration & dosage
MH  - Randomized Controlled Trials as Topic
MH  - Taxoids/therapeutic use
MH  - Treatment Outcome
EDAT- 2012/10/02 06:00
MHDA- 2013/08/06 06:00
CRDT- 2012/10/02 06:00
PHST- 2012/04/23 00:00 [received]
PHST- 2012/06/29 00:00 [revised]
PHST- 2012/07/13 00:00 [accepted]
PHST- 2012/10/02 06:00 [entrez]
PHST- 2012/10/02 06:00 [pubmed]
PHST- 2013/08/06 06:00 [medline]
AID - S1558-7673(12)00168-1 [pii]
AID - 10.1016/j.clgc.2012.07.002 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2013 Mar;11(1):20-6. doi: 10.1016/j.clgc.2012.07.002. 
      Epub 2012 Sep 26.