Efficacy and Safety of Mirogabalin Therapy for Paclitaxel-Induced Peripheral Neuropathy (MICHEL Study): A Pilot Study.

Abstract

Introduction: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent adverse event without an established, standard treatment. As mirogabalin is a gabapentinoid confirmed useful for diabetic, peripheral neuropathic pain, we examined the efficacy of mirogabalin for CIPN using quantitative sensory and pain analytical devices.

Methods: This was a single-arm, open-label, prospective 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. The primary endpoint was the Visual Analogue Scale (VAS) for peripheral neuropathy. Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) scores were obtained, and PainVision was used as an objective CIPN evaluation.

Results: A total of 20 patients were enrolled. The median VAS score before starting mirogabalin was 13.50 for the hands and 25.00 for the feet. After 4 weeks of treatment, there was significant worsening in the hands (VAS score of 37.00) but no significant difference was observed for the feet. There were no significant differences in PNQ of the limbs between before and 4 weeks after the mirogabalin treatment, although the mean of the Neurotoxicity Subscale of FACT/GOG-NTX significantly worsened. Median PainVision scores for feet also significantly worsened from 50.30 to 89.40, but no significant change was observed for hands. PainVision feet score changes negatively correlated with FACT/GOG-NTX total scores. In the patient satisfaction survey, 14 patients (70%) were satisfied with mirogabalin and 15 patients (75%) wanted to continue.

Conclusions: Although mirogabalin was not wholly effective for CIPN caused by paclitaxel treatment in breast cancer patients, the satisfaction survey suggests some patient-perceived benefits which cannot be detected by conventional evaluation methods.