Abteilung für Innere Medizin, Salzkammergut Klinikum Vöcklabruck, Dr.-Wilhelm-Bock-Straße 1, A-4840, Vöcklabruck, Austria.
Ordensklinikum Linz Barmherzige Schwestern/Elisabethinen, Linz, Austria.
Support Care Cancer. 2020 Apr;28(4):1855-1865. doi: 10.1007/s00520-019-04988-7. Epub 2019 Jul 26.
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.
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.
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).
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.
在晚期实体瘤患者的 III 期头对头试验的综合分析中，地舒单抗在预防骨骼相关事件（SREs）方面优于唑来膦酸。定期和持续用药（持久性）是临床疗效的前提；然而，地舒单抗在现实生活中的持久性尚未确定。
这是一项在奥地利、捷克共和国、匈牙利、斯洛伐克和保加利亚的 598 名患有乳腺癌、前列腺癌、肺癌或其他实体瘤骨转移的患者中进行的单臂、前瞻性、观察性、非干预性研究，这些患者在现实临床实践中每四周接受一次地舒单抗治疗。持久性定义为在 24 或 48 周内，地舒单抗的给药间隔≤35 天。
10.9%的患者有既往 SREs。62.6%的患者在 24 周内持续用药，40.1%的患者在 48 周内持续用药。非持久性的 Kaplan-Meier 中位（95%CI）时间为 274.0 天（232.0，316.0）。非持久性最常见的原因是给药延迟。随着时间的推移，镇痛药的使用呈下降趋势，约 60%的患者无需使用任何镇痛药。整个研究期间血清钙均保持在正常范围内。三名患者确诊为颌骨坏死，每位患者的年发生率（95%CI）为 0.012（0.004，0.029）。
大多数患者在 24 周的治疗中每四周接受一次地舒单抗常规治疗。非持久性主要是由于给药延迟。不良药物反应的发生率，特别是颌骨坏死的发生率，与之前研究的预期一致。
