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).
J Natl Cancer Inst. 2015 Aug 4;107(10). doi: 10.1093/jnci/djv197. Print 2015 Oct.
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.
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.
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.
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.
放疗或伊班膦酸盐（RIB）试验是一项随机、多中心、非盲、双臂试验，旨在比较单剂量静脉内伊班膦酸盐单次输注与转移性骨痛的单次剂量放疗。
470 例患有转移性骨痛且适合局部放疗的前列腺癌患者被随机分配至放疗（单次剂量 8Gy）或静脉内伊班膦酸盐（6mg）输注组，进行非劣效性试验。在基线和第 4、8、12、26 和 52 周时使用简明疼痛量表（Brief Pain Inventory）测量疼痛。根据世界卫生组织（WHO）标准和有效镇痛评分（EAS）评估疼痛缓解情况；最大允许差异为±15%。在第 4 周时未缓解的患者可选择改用其他治疗方法。在基线和第 4 周和 12 周时评估生活质量（QoL）。由于试验设计为单侧 5%检验，我们提供了疼痛反应差异的 90%置信区间（双侧）。
总体而言，在第 4 周或第 12 周时，疼痛缓解在统计学上没有差异（WHO：-3.7%，90%置信区间[CI] = -12.4%至 5.0%；和 6.7%，90%CI = -2.6 至 16.0%）。EAS 对应的差异分别为-7.5%和-3.5%。然而，放疗有更快的初始反应。虽然两种治疗方法都有不同的副作用，但毒性没有总体差异。在第 4 周和第 12 周时 QoL 相似。两组的总生存情况相似，但接受再治疗的患者比未接受再治疗的患者更好。
对于转移性前列腺骨痛，伊班膦酸盐单次输注的结果与单次剂量放疗相似。当放疗不可用时，可以考虑伊班膦酸盐。
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