内路辛引导的他莫昔芬剂量减少对原发性乳腺癌患者内分泌副作用的影响。
The impact of endoxifen-guided tamoxifen dose reductions on endocrine side-effects in patients with primary breast cancer.
发表日期:2023 Feb 06
作者:
S M Buijs, E Oomen-de Hoop, C L Braal, M M van Rosmalen, J C Drooger, Q C van Rossum-Schornagel, M B Vastbinder, S L W Koolen, A Jager, R H J Mathijssen
来源:
ESMO Open
摘要:
Tamoxifen在性激素敏感性乳腺癌的辅助治疗中非常重要,能够大幅降低复发率;然而,几乎50%的患者因副作用而无法坚持用药。本研究旨在研究内度酚指导下的降低剂量,是否能够减少副作用。本研究研究了具有烦人副作用和内度酚水平≥32 nM患者的降低剂量效果,并与仍然使用20毫克的患者进行了比较。使用功能评估癌症治疗-内分泌症状(FACT-ES)问卷,评估了激素症状和健康相关生命质量(HR-QOL),并在3个月后进行了评估。20名患者的剂量被降低,其中17名患者可评估副作用分析。在41%和65%的患者中,激素症状和HR-QOL分别观察到了>6分的临床意义改善。总体而言,剂量降低后,激素症状[5.7,95%置信区间(CI)-0.5-11.5]和HR-QOL(8.2,95% CI 0.9-15.4)显著且发生了临床意义上的改善。不降低剂量的患者(n=60)没有观察到这种情况。在21%的患者中,内度酚略微降低至16 nM阈值以下(12.8,15.5,15.8,15.9 nM)。内度酚指导下的降低剂量能够显著改善与tamoxifen相关的副作用和HR-QOL。近80%的患者的内度酚水平仍高于最保守的阈值。版权所有©2023年作者。由Elsevier Ltd.出版。保留所有权利。
Tamoxifen is important in the adjuvant treatment of hormone-sensitive breast cancer and substantially reduces recurrence; however, almost 50% of patients are non-compliant mainly due to side-effects. The aim of this study was to investigate whether endoxifen-guided tamoxifen dose reduction could lead to fewer side-effects.Effects of tamoxifen dose reduction were investigated in patients with bothersome side-effects and endoxifen levels ≥32 nM and compared to patients with side-effects who remained on tamoxifen 20 mg. Endocrine symptoms and health-related quality of life (HR-QOL) were assessed after 3 months with the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire.Tamoxifen dose was reduced in 20 patients, 17 of whom were assessable for side-effect analyses. A clinically relevant improvement of >6 points was observed in endocrine symptoms and HR-QOL in 41% and 65% of the patients, respectively. In total, there was a significant and clinically relevant improvement in endocrine symptoms [5.7, 95% confidence interval (CI) -0.5-11.5] and HR-QOL (8.2, 95% CI 0.9-15.4) after dose reduction. This was not seen in patients whose doses were not reduced (n = 60). In 21% of patients, endoxifen dropped slightly below the 16-nM threshold (12.8, 15.5, 15.8, 15.9 nM).Endoxifen-guided dose reduction of tamoxifen significantly improved tamoxifen-related side-effects and HR-QOL. Nearly 80% of patients remained above the most conservative endoxifen threshold.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.