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首页> 外文期刊>Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer >Prospective observational study to evaluate the persistence of treatment with denosumab in patients with bone metastases from solid tumors in routine clinical practice: final analysis
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Prospective observational study to evaluate the persistence of treatment with denosumab in patients with bone metastases from solid tumors in routine clinical practice: final analysis

机译：常规观测研究评估常规肿瘤骨转移患者治疗持续治疗的持续性研究：终止分析

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Purpose In the integrated analysis of phase III head-to-head trials in patients with advanced solid tumors, denosumab demonstrated superiority over zoledronic acid in preventing skeletal-related events (SREs). Regular and continued drug use (persistence) is a precondition of clinical efficacy; persistence in real-life is yet undetermined for denosumab. Methods This was a single-arm, prospective, observational, non-interventional study in 598 patients with bone metastases from breast, prostate, lung, or other solid tumors treated with denosumab every four weeks in real-world clinical practice in Austria, Czech Republic, Hungary, Slovakia, and Bulgaria. Persistence was defined as denosumab administration at <= 35-day intervals over 24 or 48 weeks, respectively. Results Previous SREs were found in 10.9% of patients. 62.6% were persistent over 24 weeks and 40.1% over 48 weeks. The Kaplan-Meier median (95% CI) time to non-persistence was 274.0 days (232.0, 316.0). The most frequent reason for non-persistence was delayed administration. There was a trend towards weaker analgesics over time, with approximately 60% of patients not requiring any analgesics. Serum calcium remained within the normal range throughout the study. Adjudicated osteonecrosis of the jaw was documented in three patients with an incidence per patient-year (95% CI) of 0.012 (0.004, 0.029). Conclusions Most patients received denosumab regularly once every four weeks over 24 weeks of treatment. Non-persistence was mainly due to delayed administration. The incidence of adverse drug reactions, especially of osteonecrosis of the jaw, was in line with expectations from previous studies.
机译：目的在先进实体瘤患者中综合分析III期头试验中，Denosumab在预防骨骼相关事件（SRES）方面证明了Zoledronic酸的优越性。经常和持续的药物使用（持久性）是临床疗效的前提;现实生活中的持久性尚未确定Denosumab。方法这是在奥地利奥地利现实世界临床实践中，捷克共和国在现实世界临床实践中使用Denosumab治疗的598名骨转移患者中的单臂，前瞻性，观察性，非介入性，在598名患有乳腺癌，前列腺，肺或其他4周内治疗的实体肿瘤患者，匈牙利，斯洛伐克和保加利亚。持续存在于24或48周的<= 35天间隔的Denosumab管理。结果以往的10.9％的患者发现了以前的SRES。 62.6％超过24周持续存在，40.1％超过48周。 Kaplan-Meier中位数（95％CI）的非持久性时间为274.0天（232.0,316.0）。非持久性最常见的原因是延迟管理。随着时间的推移，镇痛药的趋势趋势，大约60％的患者不需要任何镇痛药。血清钙仍然在整个研究中的正常范围内。 jaw的判决骨折被记录在3名发病率为每年（95％CI）的患者中，0.012（0.004,0.029）。结论大多数患者在治疗后每四周定期接受Denosumab。非持久性主要是由于行政延迟。不良药物反应的发生率，特别是颌骨骨折，符合先前研究的期望。

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