title: A Multicenter Randomized Trial of Ibandronate Compared With Single-Dose Radiotherapy for Localized Metastatic Bone Pain in Prostate Cancer.
abstract: BACKGROUND
  The radiotherapy or ibandronate (RIB) trial was a randomized multicenter nonblind two-arm trial to compare intravenous ibandronate given as a single infusion with single-dose radiotherapy for metastatic bone pain.
  
  
  METHODS
  Four hundred seventy prostate cancer patients with metastatic bone pain who were suitable for local radiotherapy were randomly assigned to radiotherapy (single dose, 8 Gy) or intravenous infusion of ibandronate (6mg) in a noninferiority trial. Pain was measured using the Brief Pain Inventory at baseline and four, eight, 12, 26, and 52 weeks. Pain response was assessed using World Health Organization (WHO) criteria and the Effective Analgesic Score (EAS); the maximum allowable difference was ±15%. Patients failing to respond at four weeks were offered retreatment with the alternative treatment. Quality of life (QoL) was assessed at baseline and four and 12 weeks. Because the trial was designed with a 5% one-sided test, we provide 90% confidence intervals (two-sided) for differences in pain response.
  
  
  RESULTS
  Overall, pain response was not statistically different at four or 12 weeks (WHO: -3.7%, 90% confidence interval [CI] = -12.4% to 5.0%; and 6.7%, 90% CI = -2.6 to 16.0%, respectively). Corresponding differences using the EAS were -7.5% and -3.5%. However, a more rapid initial response with radiotherapy was observed. There was no overall difference in toxicity, although each treatment had different side effects. QoL was similar at four and 12 weeks. Overall survival was similar between the two groups but was better among patients having retreatment than those who did not.
  
  
  CONCLUSIONS
  A single infusion of ibandronate had outcomes similar to a single dose of radiotherapy for metastatic prostate bone pain. Ibandronate could be considered when radiotherapy is not available.
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS). peterhoskin@nhs.net.
authors.forename: Peter
authors.initials: P
authors.lastname: Hoskin
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Santhanam
authors.initials: S
authors.lastname: Sundar
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Krystyna
authors.initials: K
authors.lastname: Reczko
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Sharon
authors.initials: S
authors.lastname: Forsyth
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Natasha
authors.initials: N
authors.lastname: Mithal
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Bruce
authors.initials: B
authors.lastname: Sizer
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: David
authors.initials: D
authors.lastname: Bloomfield
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Sunil
authors.initials: S
authors.lastname: Upadhyay
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Paula
authors.initials: P
authors.lastname: Wilson
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Amy
authors.initials: A
authors.lastname: Kirkwood
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Michael
authors.initials: M
authors.lastname: Stratford
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Mark
authors.initials: M
authors.lastname: Jitlal
authors.affiliation: Mount Vernon Cancer Center, Northwood, UK (PH); Nottingham University Hospitals NHS Trust, Nottingham, UK (SS); Cancer Research UK & UCL Cancer Trials Center, London, UK (KR, SF, AK MJ, AH); Kent & Canterbury Hospital, Canterbury, UK (NM); Essex County Hospital, Colchester, UK (BS); Royal Sussex County Hospital, Brighton, UK (DB); Scunthorpe General Hospital, Scunthorpe, UK (SU); Bristol Haematology & Oncology Center, Bristol, UK (PW); CRUK/MRC Oxford Institute for Radiation Oncology, Oxford, UK (MS).
authors.forename: Allan
authors.initials: A
authors.lastname: Hackshaw
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000150:complications / Q000517:prevention & control* / Q000556:secondary; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010166:Palliative Care / Q000379:methods; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000556:secondary; D011788:Quality of Life; D011879:Radiotherapy Dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid