COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy
COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy
复制标题
DOI：
10.1093/annonc/mdt513
复制
发表时间：
2014-02-01
影响因子：
50.5
通讯作者：
Harbeck, N.
中科院分区：
文献类型：
--
作者：
Hadji, P.;Jackisch, C.;Harbeck, N.
COMPACT是一项在德国进行的开放标签、多中心、非介入性研究（NCT00857012）。本研究首次从常规临床实践中提供了关于绝经后激素受体阳性早期乳腺癌妇女阿那曲唑辅助治疗第一年关节痛与患者依从性之间关系的前瞻性数据。关节痛可能导致这些患者的不依从性和临床结果。这项前瞻性研究评估了绝经后激素受体阳性的早期乳腺癌妇女在阿那曲唑辅助治疗的第一年，关节痛与依从性之间的关系。临床治疗中的依从性和关节痛（COMPACT）是在德国进行的一项开放标签、多中心、非介入性研究。患者在研究开始前3-6个月开始使用阿那曲唑辅助治疗。主要终点是关节痛、依从性以及依从性与关节痛之间的关系，在特定时间点进行评估。总的来说，1916名患者接受了阿那曲唑的前期治疗。平均关节痛评分从每次就诊的基线增加到9个月。阿那曲唑治疗依从性从基线到9个月逐渐下降（P < 0.001）。在9个月时，研究人员估计有95%的患者依从，而患者报告的依从率低于70%。在6个月（P < 0.0001）、9个月（P < 0.0001）和总体（P < 0.0001）时，关节痛平均评分与不依从性有显著相关性。随着时间的推移，14%（3个月）、11%（6个月）和9%（9个月）的患者报告了新的事件或现有关节痛的损害。关节痛在早期乳腺癌妇女的临床治疗中很重要，可能导致不依从性和临床结果。
COMPACT was an open-label, multicenter, noninterventional study (NCT00857012) conducted in Germany. This study provided the first prospective data from routine clinical practice on the relationship between arthralgia and patient compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer. Arthralgia may contribute to noncompliance and clinical outcomes in these patients.This prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer.COMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3-6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time points.Overall, 1916 patients received upfront anastrozole. Mean arthralgia scores were increased from baseline at each visit up to 9 months. Compliance with anastrozole therapy gradually decreased over time from baseline to 9 months (P < 0.001). At 9 months, investigators estimated that > 95% of patients were compliant versus patient reports of < 70%. There was a significant association between arthralgia mean scores and noncompliance at 6 months (P < 0.0001), 9 months (P < 0.0001), and overall (P < 0.0001). Over time, new events or impairment of existing arthralgias were reported in 14% (3 months), 11% (6 months), and 9% (9 months) of patients.Arthralgia is important in the clinical management of women with early breast cancer and may contribute to noncompliance and clinical outcomes.