骨改良药物又称骨调节剂、骨转换剂、骨修复剂，主要包括双膦酸盐（帕米膦酸、唑来膦酸）、地诺单抗（又称德尼单抗、狄诺塞麦）
2017年10月16日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表密歇根大学、美国临床肿瘤学会、西雅图癌症研究与生物统计学研究所、加利福尼亚州希望之城国家医学中心、佐治亚州哈滨医院、波士顿达纳法伯癌症研究所、麻省总医院、德克萨斯大学MD安德森癌症中心、内布拉斯加大学、渥太华医院癌症中心、汉密尔顿朱拉文斯基医院癌症中心、安大略省伦敦地区癌症治疗中心合作起草的美国临床肿瘤学会与安大略省癌症治疗中心指南专项更新：骨改良药物（又称骨调节剂、骨转换剂、骨修复剂）对转移性乳腺癌的作用。
该专项更新主要针对骨改良药物对于控制骨痛的作用，以及关于给药间隔的新数据。
美国临床肿瘤学会与安大略省癌症治疗中心指南更新联合委员会对目标文献进行系统回顾，确定以下相关研究：
3篇关于唑来膦酸给药间隔的III期非劣效研究（ZOOM、OPTIMIZE2、CALGB70604）
1篇关于骨改良药物减少给药频次研究的系统回顾和荟萃分析
2篇关于骨改良药物控制骨转移继发疼痛的随机对照研究（NCT00321464）
推荐意见
有骨转移证据的乳腺癌患者应该接受骨改良药物治疗。
药物选择包括：
地诺单抗：皮下注射，120mg，每4周1次
帕米膦酸：静脉注射，90mg，每3～4周1次
唑来膦酸：静脉注射，4mg，每12周或每3～4周1次，每次不少于15分钟
骨改良药物的止痛效果不大，不应该被单独用于骨痛。
推荐使用现有的支持治疗和疼痛管理标准方案（镇痛、辅助疗法、放射疗法、手术、全身抗癌疗法、转至支持治疗和疼痛管理专科）。
现有证据不足以支持任何一种骨改良药物优于其他骨改良药物。
考虑长期使用骨改良药物时，应该权衡作用机制以及潜在利弊。
患者肌酐清除率>60mL/min时，不需改变剂量、输注时间或间隔时间；每次静脉双膦酸盐给药时监测肌酐水平。
患者肌酐清除率<30mL/min或透析时，可以使用地诺单抗治疗，推荐密切监测低钙血症。
所有患者使用骨改良药物前应该进行牙科检查和预防性牙科治疗。
不推荐生物化学标志常规用于骨改良药物用药监测。
该专项更新适用于以下指南：
American Society of Clinical Oncology clinical practice guideline update: Recommendations on the role of bone-modifying agents in metastatic breast cancer. J Oncol Pract. 2011;7:117-121.
Use of adjuvant bisphosphonates and other bone-modifying agents in breast cancer: A Cancer Care Ontario and American Society of Clinical Oncology Clinical practice guideline. J Clin Oncol. 2017;35:2062-2081.
Integration of palliative care into standard oncology care: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2017;35:96-112.
Management of chronic pain in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2016;34:3325-3345.
American Cancer Society/American Society of Clinical Oncology breast cancer survivorship care guideline. J Clin Oncol. 2016;34:611-635.
相关阅读
J Clin Oncol. 2017 Oct 16. [Epub ahead of print]
Role of Bone-Modifying Agents in Metastatic Breast Cancer: An American Society of Clinical Oncology-Cancer Care Ontario Focused Guideline Update.
Van Poznak C, Somerfield MR, Barlow WE, Biermann JS, Bosserman LD, Clemons MJ, Dhesy-Thind SK, Dillmon MS, Eisen A, Frank ES, Jagsi R, Jimenez R, Theriault RL, Vandenberg TA, Yee GC, Moy B.
University of Michigan, Ann Arbor, MI; American Society of Clinical Oncology, Alexandria, VA; Cancer Research and Biostatistics, Seattle, WA; City of Hope, Duarte, CA; The Ottawa Hospital Cancer Centre, Ottawa; Juravinski Hospital and Cancer Centre, Hamilton; London Regional Cancer Program, London, Ontario, Canada; Harbin Clinic, Rome, GA; Dana-Farber Cancer Institute; Massachusetts General Hospital, Boston, MA; MD Anderson Cancer Center, Houston, TX; University of Nebraska Medical Center, Omaha, NE.
PURPOSE: To update, in collaboration with Cancer Care Ontario (CCO), key recommendations of the American Society of Clinical Oncology (ASCO) guideline on the role of bone-modifying agents (BMAs) in metastatic breast cancer. This focused update addressed the new data on intervals between dosing and the role of BMAs in control of bone pain.
METHODS: A joint ASCO-CCO Update Committee conducted targeted systematic literature reviews to identify relevant studies.
RESULTS: The Update Committee reviewed three phase III noninferiority trials of dosing intervals, one systematic review and meta-analysis of studies of de-escalation of BMAs, and two randomized trials of BMAs in control of pain secondary to bone metastases.
RECOMMENDATIONS: Patients with breast cancer who have evidence of bone metastases should be treated with BMAs. Options include denosumab, 120 mg subcutaneously, every 4 weeks; pamidronate, 90 mg intravenously, every 3 to 4 weeks; or zoledronic acid, 4 mg intravenously every 12 weeks or every 3 to 4 weeks. The analgesic effects of BMAs are modest, and they should not be used alone for bone pain. The Update Committee recommends that the current standard of care for supportive care and pain management—analgesia, adjunct therapies, radiotherapy, surgery, systemic anticancer therapy, and referral to supportive care and pain management—be applied. Evidence is insufficient to support the use of one BMA over another.
PMID: 29035643
DOI: 10.1200/JCO.2017.75.4614
J Oncol Pract. 2017 Oct 16. [Epub ahead of print]
Role of Bone-Modifying Agents in Metastatic Breast Cancer: An American Society of Clinical Oncology-Cancer Care Ontario Focused Guideline Update Summary.
Van Poznak C, Somerfield MR, Moy B.
University of Michigan, Ann Arbor, MI; American Society of Clinical Oncology, Alexandria, VA; Massachusetts General Hospital, Boston, MA.
PMID: 29035617
DOI: 10.1200/JOP.2017.027672
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