Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases
Incidence, risk factors, and outcomes of osteonecrosis of the jaw: integrated analysis from three blinded active-controlled phase III trials in cancer patients with bone metastases
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DOI：
10.1093/annonc/mdr435
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发表时间：
2012-05-01
影响因子：
50.5
通讯作者：
Dansey, R.
中科院分区：
文献类型：
--
作者：
Saad, F.;Brown, J. E.;Dansey, R.
颌骨骨坏死（ONJ）在转移性骨病接受双膦酸盐治疗的患者中有报道。在接受抗骨吸收治疗的转移性骨病患者的3个III期试验中，对ONJ的发病率、危险因素和结局进行了综合分析。继发于实体瘤或骨髓瘤的骨转移患者被随机分配每4周接受s.c. denosumab （120mg）或静脉注射唑来膦酸（4mg）。研究者在基线和每6个月进行一次研究中的口腔检查。口腔不良事件由一个独立的牙科专家盲法委员会裁决。在入组的5723例患者中，89例（1.6%）患者被确定为ONJ: 37例（1.3%）患者接受唑来膦酸治疗，52例（1.8%）患者接受地诺单抗治疗（P = 0.13）。据报道，61.8%的ONJ患者拔牙。95%的患者接受ONJ保守治疗。截至2010年10月，36.0%的患者（唑来膦酸组29.7%，地诺单抗组40.4%）的ONJ得到缓解。在这三个前瞻性试验的综合分析中，ONJ很少发生，治疗大多是保守的，超过三分之一的患者愈合。在骨靶向治疗之前和期间对医生进行口腔健康教育可能有助于减少ONJ的发生率并改善治疗效果。
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving bisphosphonates for metastatic bone disease. ONJ incidence, risk factors, and outcomes were evaluated in a combined analysis of three phase III trials in patients with metastatic bone disease receiving antiresorptive therapies.Patients with bone metastases secondary to solid tumors or myeloma were randomly assigned to receive either s.c. denosumab (120 mg) or i.v. zoledronic acid (4 mg) every 4 weeks. On-study oral examinations were conducted by investigators at baseline and every 6 months. Oral adverse events were adjudicated by an independent blinded committee of dental experts.Of 5723 patients enrolled, 89 (1.6%) patients were determined to have ONJ: 37 (1.3%) received zoledronic acid and 52 (1.8%) received denosumab (P = 0.13). Tooth extraction was reported for 61.8% of patients with ONJ. ONJ treatment was conservative in > 95% of patients. As of October 2010, ONJ resolved in 36.0% of patients (29.7% for zoledronic acid and 40.4% for denosumab).In this combined analysis of three prospective trials, ONJ was infrequent, management was mostly conservative, and healing occurred in over one-third of the patients. Educating physicians about oral health before and during bone-targeted therapy may help reduce ONJ incidence and improve outcomes.