Analysis Group, Inc, Boston, MA 02199, USA.
Clin Lymphoma Myeloma Leuk. 2011 Aug;11(4):326-35. doi: 10.1016/j.clml.2011.04.004. Epub 2011 May 6.
This study retrospectively compared the risks of skeletal-related events (SREs) and zoledronic acid (ZOL) treatment discontinuation associated with early vs. delayed ZOL therapy for patients with symptomatic multiple myeloma (MM).
Data were collected from a physician-administered medical chart review among US patients with a confirmed diagnosis of symptomatic MM treated after 01/01/2002. Early and delayed ZOL therapy were defined, respectively, as initiating ZOL ≤ 60 days (N = 126) vs. > 60 days (N = 186) after the first symptomatic MM diagnosis. Kaplan-Meier analysis with a log-rank test was performed to compare the risk of SREs between the cohorts. Cox proportional hazard modeling compared the risk of SREs associated with early vs. delayed ZOL treatment, controlling for demographic factors, stage of MM, bone health status, and presence of major comorbidities at diagnosis. Time to ZOL discontinuation was evaluated using the Kaplan-Meier method, following patients from the date of ZOL initiation.
Time to the first SRE was significantly longer for patients who received early treatment with ZOL (P = .005). At 2 years after diagnosis, the SRE-free rate was 74.6% vs. 56.5% in the early vs. delayed treatment group, respectively. Early ZOL therapy was associated with a significantly lower risk of any SRE (hazard rate [HR] = .625 vs. delayed ZOL therapy; P = .029). At 2 years from ZOL therapy initiation, rates of ZOL discontinuation were 9.6% vs. 16.4% among patients with early vs. delayed therapy, respectively (P < .05).
Early treatment with ZOL was associated with significantly reduced risks of SREs and with better treatment persistence compared with delayed treatment.
本研究回顾性比较了早期与延迟唑来膦酸(zoledronic acid,ZOL)治疗对有症状多发性骨髓瘤(multiple myeloma,MM)患者的骨骼相关事件(skeletal-related events,SREs)风险和 ZOL 治疗停药率的影响。
数据来自美国接受过治疗且有确诊症状性 MM 病史的患者,这些患者的治疗时间在 2002 年 1 月 1 日之后。早期 ZOL 治疗和延迟 ZOL 治疗分别定义为:首次诊断为症状性 MM 后≤60 天(N=126)和>60 天(N=186)开始 ZOL 治疗。采用 Kaplan-Meier 分析和对数秩检验比较两组 SRE 风险。Cox 比例风险模型用于比较早期与延迟 ZOL 治疗与 SRE 风险的相关性,同时控制了人口统计学因素、MM 分期、骨骼健康状况和诊断时主要合并症的存在情况。采用 Kaplan-Meier 法评估 ZOL 停药时间,从 ZOL 起始日期开始随访患者。
早期 ZOL 治疗患者发生首次 SRE 的时间明显更长(P=0.005)。诊断后 2 年,早期治疗组的 SRE 无事件率为 74.6%,而延迟治疗组为 56.5%(P=0.029)。早期 ZOL 治疗与任何 SRE 的风险显著降低相关(风险率[hazard rate,HR]=0.625,与延迟 ZOL 治疗相比;P=0.029)。从 ZOL 治疗开始后 2 年,早期治疗组和延迟治疗组的 ZOL 停药率分别为 9.6%和 16.4%(P<0.05)。
与延迟 ZOL 治疗相比,早期 ZOL 治疗可显著降低 SRE 风险,提高治疗的持续率。