PDF(Pubmed)
Abstract：
UNASSIGNED: The Radiotherapy IBandronate (RIB) trial compared single dose radiotherapy and a single infusion of ibandronate in 470 bisphosphonate naïve patients with metastatic bone pain from prostate cancer randomised into a non-inferiority two arm study. Results for the primary endpoint of pain score response at 4 weeks showed that the ibandronate arm was non-inferior to single dose radiotherapy.
UNASSIGNED: In addition to pain assessments including analgesic use made at baseline, 4, 8, 12, 26 and 52 weeks, urine was collected at baseline, 4 and 12 weeks. It was subsequently analysed for urinary N-telopeptide (NTx) and cystatin C. Linear regression models were used to compare the continuous outcome measures for urinary markers within treatment arms and baseline measurements were included as covariates. Interaction terms were fitted to allow for cross-treatment group comparisons.
UNASSIGNED: The primary endpoint of the RIB trial was worst pain response at 4 weeks and there was no treatment difference seen. Urine samples and paired pain scores at 4 weeks were available for 273 patients (radiotherapy 168; ibandronate 159)The baseline samples measured for the RIB trial had an average concentration of 193 nM BCE/mM creatinine (range of 7.3-1871) compared to the quoted normal range of 33 nM BCE/mM creatinine (3 to 63). In contrast the average value of Cystatin C was 66 ng/ml (ranges ND - 1120 ng/ml) compared to the quoted normal range of 62.9 ng/ml (ranges 12.6-188 ng/ml). A statistically significant reduction in NTx concentrations between baseline and 4 weeks was seen in the ibandronate arm but not in the radiotherapy arm. No correlation between pain response and urinary marker concentration was seen in either the ibandronate or radiotherapy cohort at any time point.
UNASSIGNED: NTx was significantly raised compared to the normal range consistent with a role as a biomarker for bone metastases from prostate cancer. A significant reduction in NTx 4 weeks after ibandronate is consistent with its action in osteoclast inhibition which was not seen after radiotherapy implying a different mode of action for radiation. There was no correlation between bone biomarker levels and pain response.
UNASSIGNED: In addition to pain assessments including analgesic use made at baseline, 4, 8, 12, 26 and 52 weeks, urine was collected at baseline, 4 and 12 weeks. It was subsequently analysed for urinary N-telopeptide (NTx) and cystatin C. Linear regression models were used to compare the continuous outcome measures for urinary markers within treatment arms and baseline measurements were included as covariates. Interaction terms were fitted to allow for cross-treatment group comparisons.
UNASSIGNED: The primary endpoint of the RIB trial was worst pain response at 4 weeks and there was no treatment difference seen. Urine samples and paired pain scores at 4 weeks were available for 273 patients (radiotherapy 168; ibandronate 159)The baseline samples measured for the RIB trial had an average concentration of 193 nM BCE/mM creatinine (range of 7.3-1871) compared to the quoted normal range of 33 nM BCE/mM creatinine (3 to 63). In contrast the average value of Cystatin C was 66 ng/ml (ranges ND - 1120 ng/ml) compared to the quoted normal range of 62.9 ng/ml (ranges 12.6-188 ng/ml). A statistically significant reduction in NTx concentrations between baseline and 4 weeks was seen in the ibandronate arm but not in the radiotherapy arm. No correlation between pain response and urinary marker concentration was seen in either the ibandronate or radiotherapy cohort at any time point.
UNASSIGNED: NTx was significantly raised compared to the normal range consistent with a role as a biomarker for bone metastases from prostate cancer. A significant reduction in NTx 4 weeks after ibandronate is consistent with its action in osteoclast inhibition which was not seen after radiotherapy implying a different mode of action for radiation. There was no correlation between bone biomarker levels and pain response.
摘要：
■放疗IBandronate（RIB）试验比较了单剂量放疗和单次输注伊班膦酸钠在470名二膦酸盐初治前列腺癌转移性骨痛患者中随机分为非劣效性两组研究。4周时疼痛评分反应的主要终点结果显示，伊班膦酸钠臂不劣于单剂量放疗。
■除了疼痛评估，包括在基线时使用镇痛药，4、8、12、26和52周，在基线时收集尿液，4和12周。随后分析尿N-端肽(NTx)和胱抑素C。使用线性回归模型比较治疗组内尿标志物的连续结果测量值,并包括基线测量值作为协变量。拟合相互作用项以允许交叉治疗组比较。
■RIB试验的主要终点是4周时疼痛反应最差，没有观察到治疗差异。273名患者可获得4周时的尿样和配对疼痛评分（放疗168；伊班膦酸钠159）。与引用的33nMBCE/mM肌酐的正常范围（3至63）相比，RIB试验测得的基线样品的平均浓度为193nMBCE/mM肌酐（7.3-1871）。相比之下,胱抑素C的平均值为66ng/ml(范围ND-1120ng/ml),而引用的正常范围为62.9ng/ml(范围12.6-188ng/ml)。在基线和4周之间NTx浓度的统计学显着降低见于伊班膦酸钠臂而不是放疗臂。在任何时间点，在伊班膦酸钠或放疗队列中均未发现疼痛反应与尿标志物浓度之间存在相关性。
■与正常范围相比，NTx显着升高，这与作为前列腺癌骨转移的生物标志物的作用一致。伊班膦酸盐后4周NTx的显着降低与其在破骨细胞抑制中的作用一致，这在放疗后未见，这暗示了辐射的不同作用方式。骨生物标志物水平与疼痛反应之间没有相关性。
■除了疼痛评估，包括在基线时使用镇痛药，4、8、12、26和52周，在基线时收集尿液，4和12周。随后分析尿N-端肽(NTx)和胱抑素C。使用线性回归模型比较治疗组内尿标志物的连续结果测量值,并包括基线测量值作为协变量。拟合相互作用项以允许交叉治疗组比较。
■RIB试验的主要终点是4周时疼痛反应最差，没有观察到治疗差异。273名患者可获得4周时的尿样和配对疼痛评分（放疗168；伊班膦酸钠159）。与引用的33nMBCE/mM肌酐的正常范围（3至63）相比，RIB试验测得的基线样品的平均浓度为193nMBCE/mM肌酐（7.3-1871）。相比之下,胱抑素C的平均值为66ng/ml(范围ND-1120ng/ml),而引用的正常范围为62.9ng/ml(范围12.6-188ng/ml)。在基线和4周之间NTx浓度的统计学显着降低见于伊班膦酸钠臂而不是放疗臂。在任何时间点，在伊班膦酸钠或放疗队列中均未发现疼痛反应与尿标志物浓度之间存在相关性。
■与正常范围相比，NTx显着升高，这与作为前列腺癌骨转移的生物标志物的作用一致。伊班膦酸盐后4周NTx的显着降低与其在破骨细胞抑制中的作用一致，这在放疗后未见，这暗示了辐射的不同作用方式。骨生物标志物水平与疼痛反应之间没有相关性。
