Paclitaxel-induced Peripheral Neuropathy and Quality of Life: Sub-analysis of the MICHEL Study

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.