绝经后乳腺癌女性辅助内分泌治疗的依从性

Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer.

作者信息

Ziller V, Kalder M, Albert U-S, Holzhauer W, Ziller M, Wagner U, Hadji P

机构信息

Department of Gynaecology, Gynaecological Endocrinology and Oncology, Philipps-University of Marburg, Marburg, Germany.

出版信息

Ann Oncol. 2009 Mar;20(3):431-6. doi: 10.1093/annonc/mdn646. Epub 2009 Jan 15.

Abstract

BACKGROUND

The level of adherence of various pharmacological therapies in chronic diseases varies, but is predominantly low. With tamoxifen (TAM), 23% and 50% nonadherence after 1 and 4 years have been reported. Day-to-day clinical observation suggests that adherence may even be lower with aromatase inhibitors, but limited data exist on the situation in daily clinical routine. The aim of this study was to evaluate the rate of adherent patients in a randomly selected sample of postmenopausal women with primary breast cancer, who had been assigned to an adjuvant endocrine treatment with TAM or anastrozole (ANA).

MATERIALS AND METHODS

We investigated a random sample of 100 postmenopausal women with breast cancer (50 TAM and 50 ANA) who had received surgery for their primary breast cancer at our hospital in 2004/2005 and thereafter had been assigned to an adjuvant endocrine treatment. We evaluated the adherence rate with a detailed questionnaire and additionally carried out a retrospective prescription check of the hospital chart as well as calling the local physicians of our patients. A patient was counted as adherent with a self-reported tablet intake of 80% or more and if a medication possession ratio of 80% or more was achieved.

RESULTS

Regarding the baseline characteristics, a significant difference in mean age was noticed in women on ANA versus TAM [65 (+/-3) and 72 (+/-3); P<0.001]. All women on TAM and ANA reported to be adherent (100%). After controlling for prescriptions, only 40 (80%) and 27 (69%) of the women on TAM and ANA were still classified as adherent (P<0.01 and P<0.01 versus self-report). We found no significant correlation of adherence to any baseline characteristics or side-effects in a logistic regression model.

CONCLUSIONS

An important goal of any therapeutic intervention is to achieve comparable efficacy in routine clinical practice to that demonstrated in randomised clinical trials. However, a similar magnitude of adherence will be necessary in routine clinical practice to assure comparable clinical effects. Our results further support the data on suboptimal adherence of women with breast cancer on adjuvant TAM treatment. Here, we evaluated for the first time the patient reported and real-world adherence on adjuvant ANA and were able to show a similarly low adherence compared with TAM. More prospective studies are needed to increase our understanding of the underlying reasons for nonadherence in women with breast cancer.

摘要

背景

各种慢性疾病药物治疗的依从性水平各不相同,但总体较低。据报道,他莫昔芬(TAM)治疗1年和4年后的不依从率分别为23%和50%。日常临床观察表明,芳香酶抑制剂的依从性可能更低,但关于日常临床实践中的情况数据有限。本研究的目的是评估随机选取的绝经后原发性乳腺癌女性样本中接受TAM或阿那曲唑(ANA)辅助内分泌治疗的患者的依从率。

材料与方法

我们调查了100例绝经后乳腺癌女性的随机样本(50例接受TAM治疗,50例接受ANA治疗),这些患者于2004/2005年在我院接受了原发性乳腺癌手术,此后被分配接受辅助内分泌治疗。我们通过详细问卷评估依从率,并另外对医院病历进行回顾性处方检查以及致电患者的当地医生。如果患者自我报告片剂摄入量达到80%或更多且药物持有率达到80%或更多,则计为依从。

结果

关于基线特征,接受ANA治疗与接受TAM治疗的女性在平均年龄上存在显著差异[分别为65(±3)岁和72(±3)岁;P<0.001]。所有接受TAM和ANA治疗的女性均报告依从(100%)。在核对处方后,接受TAM和ANA治疗的女性中分别只有40例(80%)和27例(69%)仍被归类为依从(与自我报告相比,P<0.01和P<0.01)。在逻辑回归模型中,我们未发现依从性与任何基线特征或副作用之间存在显著相关性。

结论

任何治疗干预的一个重要目标是在常规临床实践中实现与随机临床试验中所证明的疗效相当。然而,在常规临床实践中需要有类似程度的依从性以确保获得相当的临床效果。我们的结果进一步支持了关于乳腺癌女性辅助TAM治疗依从性欠佳的数据。在此,我们首次评估了患者报告的以及实际的辅助ANA治疗依从性,并能够显示与TAM相比依从性同样较低。需要更多前瞻性研究来增进我们对乳腺癌女性不依从潜在原因的理解。

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