OptumInsight, Health Economics and Outcomes Research, Eden Prairie, MN 55344, USA.
J Med Econ. 2012;15(1):195-204. doi: 10.3111/13696998.2011.650489. Epub 2011 Dec 23.
For patients with bone metastases, skeletal-related events including fracture are common, can cause considerable morbidity, and may reduce overall survival (OS). This retrospective analysis assessed the effect of Zometa (zoledronic acid, ZOL), an intravenous bisphosphonate (IV-BP), on fracture risk and OS in patients with bone metastases from lung cancer (LC). (Zometa is a registered trademark of Novartis Pharmaceuticals Corporation, USA.)
A claims-based analysis using commercial and Medicare Advantage data from >45 US managed-care plans was used to evaluate the association between fracture risk and treatment persistency (31-90, 91-180, 181-365, and ≥366 days) and follow-up duration in LC patients diagnosed with bone metastases between 01/01/2001 and 12/31/2006 and treated with ZOL or without (no IV-BP). Persistency was defined as the absence of a >45-day gap between ZOL treatments. Analysis of variance tests were used to compare follow-up duration, a proxy for OS, between ZOL persistency groups. The effect of time to treatment with ZOL was also assessed.
In 9874 LC patients with bone metastases (n = 1090 ZOL; n = 8784 no IV-BP) the unadjusted relative fracture risk was reduced by 40% with ZOL vs no IV-BP; fracture risk decreased consistently with increasing duration of ZOL treatment. Even short-term (31-90 days) ZOL significantly reduced fracture risk (47%) vs no IV-BP (p = 0.005) with adjustment for differences in demographic and clinical characteristics. Delaying ZOL until after bone metastases were diagnosed significantly increased fracture risk (p = 0.0017). For a sub-set of patients included in a survival analysis (n = 550 ZOL; n = 4512 no IV-BP), mortality was significantly lower (mean, 38.6 vs 46.8 deaths/100 person-years; p = 0.038) in those treated with ZOL vs no IV-BP.
Interpretation of this claims-based analysis must be tempered by the inherent limitations of observational data, such as limited clinical information and the ability to control for prognostic factors.
This retrospective analysis demonstrates that LC patients with bone metastases receiving ZOL had significantly reduced risk of fracture (p = 0.005) and death (p < 0.038) vs patients receiving no IV-BP. Longer ZOL persistency consistently yielded better outcomes, with ≥12 months' treatment producing the greatest benefit.
对于患有骨转移的患者，骨骼相关事件（包括骨折）很常见，会导致相当大的发病率，并可能降低总体生存率（OS）。这项回顾性分析评估了唑来膦酸（zoledronic acid，ZOL）（一种静脉双膦酸盐[IV-BP]）对肺癌（LC）骨转移患者骨折风险和 OS 的影响。（Zometa 是诺华制药公司的注册商标，美国）。
使用来自 45 个以上美国管理式医疗计划的商业和医疗保险优势数据进行基于索赔的分析，评估 LC 患者在 2001 年 1 月 1 日至 2006 年 12 月 31 日期间诊断为骨转移并接受 ZOL 或未接受（无 IV-BP）治疗的骨折风险与治疗持续时间（31-90、91-180、181-365 和≥366 天）和随访时间之间的关联。无中断是指 ZOL 治疗之间没有超过 45 天的间隔。方差分析检验用于比较 ZOL 持续时间组之间的随访时间，这是 OS 的替代指标。还评估了治疗开始后时间对 ZOL 的影响。
在 9874 名患有骨转移的 LC 患者中（n=1090 名 ZOL；n=8784 名无 IV-BP），与无 IV-BP 相比，ZOL 使未经调整的相对骨折风险降低了 40%；随着 ZOL 治疗时间的延长，骨折风险持续降低。即使是短期（31-90 天）的 ZOL 治疗也显著降低了骨折风险（47%），与无 IV-BP 相比（p=0.005），并对人口统计学和临床特征的差异进行了调整。在骨转移诊断后延迟使用 ZOL 会显著增加骨折风险（p=0.0017）。对于一项生存分析中包含的患者子集（n=550 ZOL；n=4512 名无 IV-BP），与无 IV-BP 相比，ZOL 治疗的死亡率显著降低（平均每 100 人年死亡 38.6 人 vs 46.8 人；p=0.038）。
必须根据观察数据的固有局限性来调整这种基于索赔的分析的解释，例如临床信息有限和控制预后因素的能力。
这项回顾性分析表明，接受 ZOL 治疗的患有骨转移的 LC 患者的骨折风险（p=0.005）和死亡率（p<0.038）显著低于接受无 IV-BP 治疗的患者。较长的 ZOL 持续时间始终产生更好的结果，≥12 个月的治疗效果最佳。
