Increased psychomotor retardation and tension as short-term neuropsychiatric adverse events of immune checkpoint inhibitors: A prospective cohort study.

INTRODUCTION: Patients undergoing cancer treatment as well as cancer survivors commonly describe behavioral alterations. As a matter of fact, neuropsychiatric adverse events (NPAEs) have been extensively described with older immunotherapies, especially with interferon alfa. However, there are little data investigating the NPAEs of immune checkpoint inhibitors (ICIs). Therefore, the aim of this study is to evaluate the safety profile of ICI in terms of NPAEs.

MATERIALS AND METHODS: This is a prospective, interventional, self-controlled study. Participants receiving ICIs as unique therapy, between February and December 2019, were evaluated at the beginning of their treatment protocol, at 1 month and finally at 3 months. During the three evaluations, disease and patients' characteristics were assessed, as well as NPAEs using the Brief Psychiatric Rating Scale (BPRS) questionnaire, the psychological stress due to cancer's burden using the Herth hope index, and the performance status (PS) using the Eastern Cooperative Oncology Group (ECOG) score.

RESULTS: Forty-four patients were enrolled, of whom 24 patients completed their three evaluation visits. No changes in BPRS total score were found throughout the study period. However, two subscores of the BPRS, "motor retardation" (P = 0.008) and "tension" or "nervousness" (P = 0.002), increased starting the 1st month of treatment. Moreover, age (r = 0.426, P = 0.038) and the baseline PS (P = 0.027) were the main risk factors of such manifestations.

CONCLUSION: This study suggests that ICI could be responsible for motor retardation and increased tension starting the 1st month of treatment, with higher ECOG score and older age being the main risk factors.