American Society of Clinical Oncology clinical practice guidelines: The role of bisphosphonates in multiple myeloma
American Society of Clinical Oncology clinical practice guidelines: The role of bisphosphonates in multiple myeloma
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DOI：
10.1200/jco.2002.06.037
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发表时间：
2002-09-01
影响因子：
45.3
通讯作者：
Biermann, JS
中科院分区：
文献类型：
--
作者：
Berenson, JR;Hillner, BE;Biermann, JS
目的：为了确定临床实践指南使用双膦酸盐;在预防和治疗多发性骨髓瘤溶骨性疾病，并确定其各自的作用相对于其他传统疗法，这种conditions.Methods：一个专家多学科小组审查相关信息，从已发表的文献，通过2002年1月。证据等级和建议等级的数值由专家审评员确定，并经小组核准。如果发表的数据不足，则采用专家共识。小组讨论了在疾病过程中治疗哪些病人以及何时治疗的问题。此外，还审查了溶骨性病变的特定药物输送问题、治疗持续时间、治疗开始和治疗管理，并与溶骨性病变的其他治疗形式进行了比较。最后，专家组讨论了患者和医生对这种骨转移治疗的期望，以及与使用双膦酸盐相关的公共政策影响。该指南进行了外部审查选定的医生，由卫生服务研究委员会成员，并由ASCO董事会Directs.Results：现有的证据涉及随机对照试验是适度的，但支持口服氯膦酸盐，静脉注射帕米膦酸盐，静脉注射唑来膦酸是优于安慰剂在减少骨骼并发症上级。在所有研究中均一致观察到椎体骨折减少。没有药物显示出明确的生存获益。最近已证明静脉注射唑来膦酸与静脉注射帕米膦酸盐一样有效。由于氯膦酸盐与帕米膦酸盐或唑来膦酸之间没有直接比较，因此无法明确确定一种药物的优效性。然而，专家组建议仅静脉注射帕米膦酸盐或唑来膦酸，因为使用至首次骨骼事件的时间作为主要终点，并且在评估其的研究中对骨骼并发症进行了更完整的评估。帕米膦酸盐和唑来膦酸之间的选择将取决于选择唑来膦酸的药物成本较高，其较短，更方便的输液时间（15分钟），与较便宜的药物，帕米膦酸盐，其较长的输液时间（2小时）。对多发性骨髓瘤伴溶骨性疾病患者有益。然而，对双膦酸盐的进一步研究是必要的，包括以下内容：（1）何时开始和停止治疗，（2）如何将其与溶骨性疾病的其他治疗方法结合使用，（3）如何评价其在无溶骨性受累的骨髓瘤患者中的作用，（4）如何区分有症状和无症状的骨事件，以及（5）如何更好地确定其成本效益后果。(C)2002年，美国临床肿瘤学会。
Purpose: To determine clinical practice guidelines for the use of bisphosphonates; in the prevention and treatment of lytic bone disease in multiple myeloma and to determine their respective role relative to other conventional therapies for this condition.Methods: An expert multidisciplinary Panel reviewed pertinent information from the published literature through January 2002. Values for levels of evidence and grade of recommendation were assigned by expert reviewers and approved by the Panel. Expert consensus was used if there were insufficient published data. The Panel addressed which patients to treat and when to treat them in the course of their disease. Additionally, specific drug delivery issues, duration of therapy, initiation of treatment and management of treatment of lytic bone disease was reviewed and compared with other forms of therapy for lytic bone lesions. Finally, the Panel discussed patient and physician expectations associated with this therapy for bony metastases, as well as public policy implications related to the use of bisphosphonates. The guidelines underwent external review by selected physicians, by the Health Services Research Committee members, and by the ASCO Board of Directors.Results: The available evidence involving randomized controlled trials is modest but supports that oral clodronate, intravenous pamidronate, and intravenous zoledronic acid are superior to placebo in reducing skeletal complications. A reduction in vertebral fractures has consistently be en seen across all studies. No agent has shown a definitive survival benefit. Intravenous zoledronic acid has recently been shown to be as effective as intravenous pamidronate. Because there are no direct comparisons between clodronate and pamidronate or zoledronic acid, the superiority of one agent cannot be definitively established. However, the panel recommends only intravenous pamidronate or zoledronic acid in light of the use of the time to first skeletal event as the primary end point and more complete assessment of bony complications in studies evaluating it. Additionally, clodronate is not available in the United States. The choice between pamidronate and zoledronic acid will depend on choosing between the higher drug cost of zoledronic acid, with its shorter, more convenient infusion time (15 minutes), versus the less expensive drug, pamidronate, with its longer infusion time (2 hours).Conclusion: Bisphosphonates; provide a meaningful supportive. benefit to multiple myeloma patients with lytic bone disease. However, further research on bisphosphonates is warranted, including the following: (1) when to start and stop therapy, (2) how to integrate their use with other treatments for lytic bone disease, (3) how to evaluate their role in myeloma patients without lytic bone involvement, (4) how to distinguish between symptomatic and asymptomatic bony events, and (5) how to better determine their cost-benefit consequence. (C) 2002 by American Society of Clinical Oncology.