Peter Hoskin1, Santhanam Sundar2, Krystyna Reczko2, Sharon Forsyth2, Natasha Mithal2, Bruce Sizer2, David Bloomfield2, Sunil Upadhyay2, Paula Wilson2, Amy Kirkwood2, Michael Stratford2, Mark Jitlal2, Allan Hackshaw2. 1. 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. 2. 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).
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.
RCT Entities:
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 cancerpatients 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: Donald L Patrick; Charles S Cleeland; Roger von Moos; Lesley Fallowfield; Rachel Wei; Katarina Öhrling; Yi Qian Journal: Support Care Cancer Date: 2014-12-23 Impact factor: 3.603
Authors: Malte Mohme; Sabine Riethdorf; Marc Dreimann; Stefan Werner; Cecile L Maire; Simon A Joosse; Frederic Bludau; Volkmar Mueller; Rui P L Neves; Nikolas H Stoecklein; Katrin Lamszus; Manfred Westphal; Klaus Pantel; Harriet Wikman; Sven O Eicker Journal: Sci Rep Date: 2017-08-03 Impact factor: 4.379
Authors: Richard Simcock; Toms Vengaloor Thomas; Christopher Estes; Andrea R Filippi; Matthew A Katz; Ian J Pereira; Hina Saeed Journal: Clin Transl Radiat Oncol Date: 2020-03-24