Serial testing to assess cognitive function in patients with cancer being treated with immunotherapy.

TPS1644 Background: The advent of immunotherapy (IT) has revolutionized lung cancer treatment, becoming a primary modality from Stages Ib to IV. While the short-term side effects of IT are well documented, its long-term impact on cognitive function are under explored. This is a crucial area of investigation given the significant impact of cognitive health on the quality of life in cancer survivors. Preclinical investigations suggest neurocognitive alterations in IT-treated patients, evidenced by increased microglial activation and cytokine release, contributing to observed cognitive deficits such as impaired cued fear memory and object recognition. This study leverages the Montreal Cognitive Assessment (MoCA) to investigate these potential cognitive changes in a clinical setting, aiming to provide crucial insights into the long-term effects of IT. Methods: This single-center, open-label pilot study enrolls patients with various cancer types and stages undergoing IT. Exclusion criteria include prior history of underlying cognitive dysfunction, dementia, depression or psychiatric illness, history of brain metastasis or radiation. The study compromises three cohorts: those receiving IT alone, those undergoing chemo-immunotherapy, and a control group with no active treatment (in remission with prior history of cancer and have received IT in the past). Each of the IT and chemo-immunotherapy groups will include 72 patients, while the control group will consist of 40 participants. Baseline cognitive function is assessed using the MoCA scale, with follow-up assessments at 3 and 6 months from baseline. Patient enrollment commenced in April 2022, with 4 patients enrolled in the IT group, 16 in the chemo-IT group, and 32 in the control group. The primary objective is to assess the Cognitive function change in each individual group of patients. The secondary objective is to assess change of MoCA scores after 3 months and 6 months in patients receiving immunotherapy alone in lung cancer patients. The changes in MoCA scores will be plotted and summarized with mean change, standard deviation of change and standard errors of mean change. MoCA scores at baseline and at 6 months will be compared using paired t-tests. The study will analyze the rate of change in MoCA scores over time, comparing outcomes across the treatment cohorts. Clinical trial information: NCT06160700 .