School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, South Korea.
Amgen Korea Limited, 203, Teheran-ro, Gangnam-gu, Seoul, South Korea.
J Bone Miner Metab. 2020 Mar;38(2):254-263. doi: 10.1007/s00774-019-01052-6. Epub 2019 Oct 31.
Investigations of ZA effectiveness using large, real-world databases are rare. We examined whether zoledronic acid (ZA) decreased the risk of skeletal-related events (SREs) among patients with bone metastases (BMs) from breast cancer (BC) or prostate cancer (PC), or multiple myeloma (MM) in routine clinical practice.
We conducted a propensity score-matched cohort study using the Korean National Health Insurance database. Our cohort included patients diagnosed with BM after BC or PC, or MM between 2004 and 2015. SRE was defined as having a record of pathologic fracture, spinal cord compression, radiation, or surgery to bone. The incidence of multiple SREs was calculated according to SRE history. We calculated the incidence rate ratio (IRR) to examine the relative difference in the risk of SREs of ZA users compared to those of ZA non-user.
Among 111,679 patients, diagnosed with BM and one of the three cancer types, 5608 were included in the analysis after propensity score matching. A decreased risk of SREs was observed for the ZA use in patients with history of SRE in BC [IRR = 0.74, 95% confidence interval (CI) = 0.66-0.83], PC (IRR = 0.86, 95% CI = 0.73-1.02), and MM (IRR = 0.74, 95% CI = 0.59-0.93). For patients without SRE history, ZA use was not associated with decreased risks of SREs, but rather increased the risks (BC: IRR = 1.96, 95% CI 1.87-2.05; PC: IRR = 1.66, 95% CI 1.54-1.80; MM: IRR = 1.92, 95% CI 1.57-2.34).
Our study suggests that the ZA use was associated with a decreased risk of SRE for patients with SRE history. However, no preventive effects of ZA were observed for patients without history.
使用大型真实世界数据库研究唑来膦酸(ZA)的疗效较为少见。我们旨在研究在常规临床实践中,ZA 是否能降低乳腺癌(BC)、前列腺癌(PC)或多发性骨髓瘤(MM)骨转移(BM)患者的骨骼相关事件(SREs)风险。
我们使用韩国国家健康保险数据库进行了倾向评分匹配队列研究。我们的队列纳入了 2004 年至 2015 年间诊断为 BM 且来自 BC 或 PC 或 MM 的患者。SRE 定义为病理性骨折、脊髓压迫、放疗或骨手术的记录。根据 SRE 病史计算多重 SRE 的发生率。我们计算了发生率比(IRR)以检验 ZA 使用者与 ZA 非使用者 SRE 风险的相对差异。
在 111679 名患者中,诊断为 BM 且患有上述三种癌症之一,经倾向评分匹配后,有 5608 名患者纳入分析。对于有 SRE 病史的 BC [IRR=0.74,95%置信区间(CI)=0.66-0.83]、PC(IRR=0.86,95%CI=0.73-1.02)和 MM(IRR=0.74,95%CI=0.59-0.93)患者,ZA 的使用降低了 SRE 风险。对于无 SRE 病史的患者,ZA 的使用与 SRE 风险降低无关,但增加了风险(BC:IRR=1.96,95%CI 1.87-2.05;PC:IRR=1.66,95%CI 1.54-1.80;MM:IRR=1.92,95%CI 1.57-2.34)。
我们的研究表明,ZA 的使用与有 SRE 病史的患者 SRE 风险降低相关。然而,对于无病史的患者,ZA 无预防作用。