Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies.
Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies.
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DOI：
10.1038/sj.bjc.6601663
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发表时间：
2004-03-22
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
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尽管静脉注射（i.v.）双膦酸盐是转移性骨病的标准治疗方法，但由于输注相关不良事件（ae）、肾毒性风险增加以及常规医院就诊的不便，对许多患者来说，它们并不理想。口服双膦酸盐治疗的使用受到疗效和胃肠道（GI）副作用的限制。临床仍然需要一种口服双膦酸盐，它能提供与静脉注射双膦酸盐同等的疗效，良好的耐受性和给药方便。口服依班膦酸盐是一种高效的第三代氨基二膦酸盐，已经在乳腺癌骨转移患者的III期临床试验中进行了评估。在两项合并的III期研究中，乳腺癌和骨转移患者被随机分组，每天一次口服伊班膦酸盐50mg （n=287）或安慰剂（n=277），持续96周。主要终点是骨骼发病率（SMPR），定义为12周内出现新的骨骼并发症的次数。多变量泊松回归分析用于评估研究期间各治疗组骨骼相关事件的相对风险。与安慰剂相比，口服伊班膦酸酯50 mg显著降低了平均SMPR （0.95 vs 1.18， P=0.004）。需要放疗的平均事件数（0.73 vs 0.98， P<0.001）和需要手术的事件数（0.47 vs 0.53， P=0.037）显著减少。泊松回归分析证实，与安慰剂相比，口服伊班膦酸盐显著降低了骨骼事件的风险（风险比0.62,95% CI=0.48, 0.79； P=0.0001）。与安慰剂组相比，口服伊班膦酸酯50 mg组轻度治疗相关上消化道不良事件的发生率略高，但很少有严重药物相关不良事件的报道。口服伊班膦酸盐50mg是一种有效、耐受性良好且方便的治疗方法，可预防转移性骨病的骨骼并发症。
Although intravenous (i.v.) bisphosphonates are the standard of care for metastatic bone disease, they are less than ideal for many patients due to infusion-related adverse events (AEs), an increased risk of renal toxicity and the inconvenience of regular hospital visits. The use of oral bisphosphonate therapy is limited by concerns over efficacy and gastrointestinal (GI) side effects. There remains a clinical need for an oral bisphosphonate that offers equivalent efficacy to i.v. bisphosphonates, good tolerability and dosing convenience. Oral ibandronate, a highly potent, third-generation aminobisphosphonate, has been evaluated in phase III clinical trials of patients with bone metastases from breast cancer. In two pooled phase III studies, patients with breast cancer and bone metastases were randomised to receive oral ibandronate 50 mg (n=287) or placebo (n=277) once daily for up to 96 weeks. The primary end point was the skeletal morbidity period rate (SMPR), defined as the number of 12-week periods with new skeletal complications. Multivariate Poisson's regression analysis was used to assess the relative risk of skeletal-related events in each treatment group during the study period. Oral ibandronate 50 mg significantly reduced the mean SMPR compared with placebo (0.95 vs 1.18, P=0.004). There was a significant reduction in the mean number of events requiring radiotherapy (0.73 vs 0.98, P<0.001) and events requiring surgery (0.47 vs 0.53, P=0.037). Poisson's regression analysis confirmed that oral ibandronate significantly reduced the risk of a skeletal event compared with placebo (hazard ratio 0.62, 95% CI=0.48, 0.79; P=0.0001). The incidence of mild treatment-related upper GI AEs was slightly higher in the oral ibandronate 50 mg group compared with placebo, but very few serious drug-related AEs were reported. Oral ibandronate 50 mg is an effective, well-tolerated and convenient treatment for the prevention of skeletal complications of metastatic bone disease.
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影响因子：
6.2
作者：
Body, JJ
通讯作者：
Body, JJ
影响因子：
45.3
作者：
Powles, T;Paterson, S;Pylkkänen, L
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Pylkkänen, L
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45.3
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Hortobagyi, GN;Theriault, RL;Reitsma, DJ
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Reitsma, DJ
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11.1
作者：
Kristensen, B;Ejlertsen, B;Mouridsen, HT
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Mouridsen, HT
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45.3
作者：
ROBERTSON, AG;REED, NS;RALSTON, SH
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RALSTON, SH