Sawa Aya, Sato Riko, Matsuo Tomohei, Okazaki Mai, Hashimoto Sachie, Iguchi-Manaka Akiko, Shimada Kensuke, Mathis Bryan J, Yamada Takeshi, Machino Takeshi, Bando Hiroko
Department of Breast-Thyroid-Endocrine Surgery, University of Tsukuba Hospital, Ibaraki, Japan.
Department of Breast and Endocrine Surgery, Institute of Medicine, University of Tsukuba, Ibaraki, Japan.
Anticancer Res. 2025 Sep;45(9):3827-3833. doi: 10.21873/anticanres.17742.
BACKGROUND/AIM: Paclitaxel, a taxane-class drug commonly used as part of a chemotherapy regimen for breast cancer, is causative for chemotherapy-induced peripheral neuropathy (CIPN). The MICHEL study was conducted to evaluate the efficacy of mirogabalin against CIPN which included, among its secondary endpoints, a questionnaire in which patients rated in detail the impact of their CIPN on their activities of daily living. In this study, we performed a sub-analysis for this secondary endpoint and attempted to identify acute changes that signaled CIPN.
This is a sub-analysis of the MICHEL study, which was a single-arm, open-label, prospective intervention pilot study conducted at the University of Tsukuba Hospital between April 2022 to April 2024. Patients with grade 2 or higher CIPN during weekly paclitaxel treatment for primary breast cancer were enrolled and received mirogabalin orally for 4 weeks. Patient Neurotoxicity Questionnaire scores were obtained and interrupted activities of daily living were examined.
A total of 20 patients were enrolled, with a median age at enrollment of 56.5 years; all were female. The median number of paclitaxel doses given before study enrollment was 5.5. The most common activities of daily living interfered with were: buttoning clothes (35%), climbing stairs (30%), walking (20%) at baseline and buttoning clothes (55%), writing (45%), walking (45%), and climbing stairs (35%) at week 5. In addition, some few patients showed improvements in activities.
Paclitaxel administration affected activities of daily living through CIPN and symptoms were primarily noted in the hands and feet with regard to fine motor hand movements and mobility. Individualized care, potentially with duloxetine or rehabilitation exercises (in addition to self-care education), may be considered stopgap measures.
背景/目的:紫杉醇是一种紫杉烷类药物,常用于乳腺癌化疗方案,可导致化疗引起的周围神经病变(CIPN)。MICHEL研究旨在评估米罗加巴林对CIPN的疗效,该研究的次要终点包括一份问卷,患者在问卷中详细评估了CIPN对其日常生活活动的影响。在本研究中,我们对该次要终点进行了亚组分析,并试图识别预示CIPN的急性变化。
这是MICHEL研究的亚组分析,MICHEL研究是一项单臂、开放标签、前瞻性干预试点研究,于2022年4月至2024年4月在筑波大学医院进行。纳入在原发性乳腺癌每周紫杉醇治疗期间出现2级或更高CIPN的患者,并口服米罗加巴林4周。获取患者神经毒性问卷评分,并检查中断的日常生活活动。
共纳入20例患者,入组时的中位年龄为56.5岁;均为女性。入组前给予的紫杉醇剂量中位数为5.5。在基线时,受影响最常见的日常生活活动是:扣纽扣(35%)、爬楼梯(30%)、行走(20%),在第5周时是扣纽扣(55%)、写字(45%)、行走(45%)和爬楼梯(35%)。此外,少数患者的活动有所改善。
紫杉醇给药通过CIPN影响日常生活活动,症状主要出现在手部和足部的精细手部运动和活动能力方面。个体化护理,可能联合度洛西汀或康复锻炼(除自我护理教育外),可被视为临时措施。