前瞻性、随机的阿比特龙食物效应试验两个臂之间的自付费用和依从性比较。
Comparison of out-of-pocket costs and adherence between the two arms of the prospective, randomized abiraterone food effect trial.
机构信息
Department of Medicine, Section of Hematology/Oncology, The University of Chicago, 5841 S. Maryland Ave, MC 2115, Chicago, IL, 60637, USA.
Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.
出版信息
Support Care Cancer. 2022 Mar;30(3):2803-2810. doi: 10.1007/s00520-021-06670-3. Epub 2021 Nov 29.
PURPOSE
Abiraterone acetate, prescribed for metastatic prostate cancer, has enhanced absorption with food. This effect was exploited in a randomized trial which showed noninferiority of PSA decline for 250 mg abiraterone with a low-fat meal (LOW) compared to 1,000 mg abiraterone fasting (STD). Drug was obtained via patient insurance. Patient out-of-pocket costs and adherence were surveyed.
METHODS
Trial participants were randomized to STD or LOW, and surveys of adherence and out-of-pocket costs were administered at baseline and just before coming off study (follow-up).
RESULTS
Out-of-pocket costs were available from 20 of 36 STD and 21 of 36 LOW patients. Median out-of-pocket costs for a month of drug were $0 (LOW) and $5 (STD); mean costs were $43.61 (LOW) and $393.83 (STD). The two groups did not differ significantly (p = 0.421). Maximum out-of-pocket cost was $1,000 (LOW) and $4,000 (STD). Monthly out-of-pocket costs > $500 were found in 1 LOW and 5 STD patients. For adherence, only 11 STD and 19 LOW patients had questionnaires completed at both baseline and follow-up. STD adherence was 98.18% at baseline and 91.69% at follow-up, differing significantly (p = 0.0078). LOW adherence was 96.52% at baseline and 97.86% at follow-up, not differing significantly (p = 0.3511). Adherence did not correlate with demographics. At follow-up, increasing adherence correlated significantly with decreasing dose (p = 0.013; rho = - 0.458).
CONCLUSIONS
Out-of-pocket costs did not differ significantly in this limited analysis. Adherence was significantly different in STD as the trial progressed, which was not found in LOW.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01543776; registered March 5, 2012.
目的
阿比特龙醋酸酯用于转移性前列腺癌，与食物同服可增强吸收。这一效果在一项随机试验中得到了利用，该试验显示与空腹服用 1000 毫克阿比特龙相比，250 毫克阿比特龙与低脂肪餐（LOW）合用可使 PSA 下降具有非劣效性（STD）。药物通过患者保险获得。对患者自付费用和依从性进行了调查。
方法
试验参与者被随机分配到 STD 或 LOW，在基线和即将退出研究（随访）前进行了依从性和自付费用调查。
结果
自付费用数据可从 36 例 STD 患者中的 20 例和 36 例 LOW 患者中的 21 例获得。一个月药物的自付费用中位数为 0 美元（LOW）和 5 美元（STD）；平均费用分别为 43.61 美元（LOW）和 393.83 美元（STD）。两组之间无显著差异（p = 0.421）。最大自付费用为 1000 美元（LOW）和 4000 美元（STD）。1 例 LOW 和 5 例 STD 患者每月自付费用超过 500 美元。关于依从性，只有 11 例 STD 和 19 例 LOW 患者在基线和随访时都完成了问卷调查。STD 的依从性在基线时为 98.18%，随访时为 91.69%，差异显著（p = 0.0078）。LOW 的依从性在基线时为 96.52%，随访时为 97.86%，无显著差异（p = 0.3511）。依从性与人口统计学无关。随访时，依从性增加与剂量减少显著相关（p = 0.013；rho = -0.458）。
结论
在这项有限的分析中，自付费用没有显著差异。在 STD 中，随着试验的进行，依从性有显著差异，而在 LOW 中则没有。
试验注册
ClinicalTrials.gov NCT01543776；注册日期：2012 年 3 月 5 日。
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