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首页> 外文期刊>Annals of oncology: official journal of the European Society for Medical Oncology >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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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

机译：颌骨坏死的发生率，危险因素和结局：癌症转移性骨癌患者的三项盲目主动对照III期临床试验的综合分析

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Background: 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 and methods: 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. Results: 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). Conclusions: 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.
机译：背景：据报道，接受双膦酸盐类药物治疗转移性骨病的患者颌骨坏死（ONJ）。在对接受抗重吸收疗法治疗的转移性骨病患者的三项III期临床试验的综合分析中，评估了ONJ的发生率，危险因素和结果。患者和方法：实体瘤或骨髓瘤继发骨转移的患者被随机分配接受皮下注射。地诺单抗（120毫克）或静脉注射唑来膦酸（4毫克）每4周一次。研究人员在基线时和每6个月进行一次研究中的口腔检查。口腔不良事件由独立的牙医专家委员会进行裁决。结果：在5723名患者中，确定有89名（1.6％）患有ONJ：37名（1.3％）接受唑来膦酸和52名（1.8％）接受地诺单抗（P = 0.13）。据报道ONJ患者中有61.8％的人拔牙。在95％以上的患者中，ONJ治疗较为保守。截至2010年10月，ONJ治愈了36.0％的患者（唑来膦酸占29.7％，地诺单抗占40.4％）。结论：在这三项前瞻性试验的综合分析中，ONJ很少见，治疗大多是保守的，治愈的患者超过三分之一。在骨靶向治疗之前和期间对医师进行口腔健康教育可能有助于减少ONJ发生率并改善结局。

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