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在美国行政索赔数据库中,晚期肾细胞癌患者使用帕唑帕尼的持续性和依从性。

Persistence and compliance with pazopanib in patients with advanced renal cell carcinoma within a U.S. administrative claims database.

机构信息

5 Crescent Dr., Philadelphia, PA 19112.

出版信息

J Manag Care Spec Pharm. 2014 Jun;20(6):603-10. doi: 10.18553/jmcp.2014.20.6.603.

Abstract

BACKGROUND

Pazopanib is an oral tyrosine kinase inhibitor with demonstrated efficacy and tolerability in patients with advanced renal cell carcinoma (RCC).

OBJECTIVE

To examine pazopanib persistence and compliance (adherence) and other drug utilization patterns in both treatment-naïve (first-line) patients and those previously treated with RCC therapy in the real-world setting. Key factors affecting persistence and compliance were also explored.

METHODS

This was a retrospective claims analysis using the Truven Health MarketScan Databases to cover claims activity from October 2007 through March 2012. Patients with advanced RCC aged ≥ 18 years who had received pazopanib with 180 days of follow-up were included. Bivariate comparisons of results from first-line and previously treated patients with RCC were conducted. Pazopanib persistence was measured using (a) estimated level of persistence with therapy (ELPT; i.e., the percentage of patients remaining on therapy at 30, 60, and 90 days [patients were censored at 180 days]); (b) time to discontinuation (i.e., duration of therapy); and (c) proportion of days covered (PDC; i.e., the ratio of [total days drug available minus days' supply of last prescription] to [last prescription date minus first prescription date]). Compliance was measured by medication possession ratio (MPR; i.e., the ratio of [total days' supply minus days' supply of last prescription] to [last prescription date minus first prescription date]). Other drug utilization measures included days' supply, time to initiation, time to switching, and dose-related measures. Random forest models were used to explore key factors of pazopanib persistence and compliance.

RESULTS

A total of 143 patients met all inclusion criteria; 43.3% were treated with pazopanib first line (first-line cohort), and 56.6% had ≥ 1 prior lines of therapy (previously treated cohort). The mean (± standard deviation [SD]) age of patients was 62.9 (± 10.3) years, and 71.3% of them were males. Continuous pazopanib therapy for up to 90 days was observed in greater than 50% of patients in both cohorts. In the first-line cohort, ELPT at 30, 60, and 90 days was 98.39%, 70.97%, and 56.45%, respectively; the mean (± SD) number of days to discontinuation was 112.2 (± 62.8); the mean (± SD) PDC was 84.7% (± 16.7%); and the mean (± SD) MPR was 85.2% (± 16.9%). Similar results were observed in the previously treated population: ELPT at 30, 60, and 90 days was 98.77%, 75.31%, and 58.02%, respectively; the mean (± SD) number of days to discontinuation was 118.7 (± 61.4); the mean (± SD) PDC was 87.8% (± 13.5%); and the mean (± SD) MPR was 90.1% (± 13.9%). Differences between the 2 cohorts were not statistically significant. More than 90% of patients in both cohorts had at least a 30-day supply of therapy (91.9% of first-line versus 90.2% of previously treated; P = 0.153). The mean (± SD) time from metastatic diagnosis to start of pazopanib therapy was 104.7 (± 199.3) days in the first-line cohort and 360.9 (± 187.0) days in previously treated patients (P = 0.001). Forty-six patients switched to another therapy: 17 patients in the first-line cohort and 29 patients in the previously treated cohort; the mean (± SD) time to switching therapy from each cohort was 94.7 (± 41.4) days and 87.8 (± 49.6) days (P = 0.146), respectively. Statistically significant differences were observed for the starting and ending doses between the 2 cohorts. The average daily dosage of pazopanib was greater than 700 mg in both cohorts (P = 0.055), with a maximum dose of 800 mg. Random forest models demonstrated that younger age and higher comorbidity predicted both higher persistence and compliance.

CONCLUSIONS

In this observational study, greater than 50% of patients with advanced RCC were on pazopanib for almost 4 months, with the majority of both cohorts achieving high persistence and high compliance. Additionally, younger age and higher comorbidity index were the strongest predictors of both greater persistence and compliance. Further studies with larger cohorts and longer follow-up are needed to validate these findings.

摘要

背景

帕唑帕尼是一种口服酪氨酸激酶抑制剂,在晚期肾细胞癌(RCC)患者中表现出疗效和耐受性。

目的

在真实环境中检查帕唑帕尼的持续时间和依从性(即药物的使用),以及在初治(一线)患者和先前接受过 RCC 治疗的患者中的其他药物使用模式。还探讨了影响持续时间和依从性的关键因素。

方法

这是一项使用 Truven Health MarketScan 数据库的回顾性索赔分析,涵盖了 2007 年 10 月至 2012 年 3 月的索赔活动。纳入了年龄≥18 岁、接受过帕唑帕尼治疗且有 180 天随访的晚期 RCC 患者。对一线治疗和先前接受过 RCC 治疗的患者进行了结果的双变量比较。使用(a)估计的治疗持续水平(ELPT;即,在 30、60 和 90 天(患者在 180 天时被截尾)仍在接受治疗的患者比例);(b)停药时间(即治疗持续时间);和(c)比例的天数覆盖(PDC;即[总药物可用天数减去最后处方的天数供应]与[最后处方日期减去第一处方日期]的比值)来衡量帕唑帕尼的持续时间。通过药物占有比例(MPR;即[总供应天数减去最后处方的天数供应]与[最后处方日期减去第一处方日期]的比值)来衡量依从性。其他药物使用措施包括天的供应、起始时间、切换时间和剂量相关措施。随机森林模型用于探索帕唑帕尼持续时间和依从性的关键因素。

结果

共有 143 名患者符合所有纳入标准;43.3%的患者一线接受帕唑帕尼治疗(一线队列),56.6%的患者有≥1线既往治疗(既往治疗队列)。患者的平均(±标准偏差[SD])年龄为 62.9(±10.3)岁,其中 71.3%为男性。在两个队列中,均观察到超过 50%的患者连续接受帕唑帕尼治疗长达 90 天。在一线队列中,ELPT 在 30、60 和 90 天分别为 98.39%、70.97%和 56.45%;平均(±SD)停药天数为 112.2(±62.8);平均(±SD)PDC 为 84.7%(±16.7%);平均(±SD)MPR 为 85.2%(±16.9%)。在既往治疗人群中也观察到类似的结果:ELPT 在 30、60 和 90 天分别为 98.77%、75.31%和 58.02%;平均(±SD)停药天数为 118.7(±61.4);平均(±SD)PDC 为 87.8%(±13.5%);平均(±SD)MPR 为 90.1%(±13.9%)。两个队列之间的差异无统计学意义。两个队列中均有超过 90%的患者至少有 30 天的治疗供应(一线队列为 91.9%,既往治疗队列为 90.2%;P=0.153)。一线队列中从转移性诊断到开始帕唑帕尼治疗的平均(±SD)时间为 104.7(±199.3)天,而既往治疗队列为 360.9(±187.0)天(P=0.001)。有 46 名患者转为其他治疗:一线队列中有 17 名患者,既往治疗队列中有 29 名患者;从每个队列开始转换治疗的平均(±SD)时间分别为 94.7(±41.4)天和 87.8(±49.6)天(P=0.146)。两个队列之间的起始和结束剂量均有统计学显著差异。两个队列中帕唑帕尼的平均日剂量均大于 700 mg(P=0.055),最大剂量为 800 mg。随机森林模型表明,年龄较小和合并症较高预测了较高的持续性和依从性。

结论

在这项观察性研究中,超过 50%的晚期 RCC 患者接受了帕唑帕尼治疗,持续时间接近 4 个月,大多数患者的持续性和依从性均较高。此外,年龄较小和较高的合并症指数是预测更高持续性和依从性的最强因素。需要更大的队列和更长的随访时间来验证这些发现。

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