A pilot study on the neurocognitive effect of sorafenib on patients with desmoid tumours: the SORA-COG study

Summary

Introduction: Sorafenib is a multikinase tyrosine kinase inhibitor whose prolonged use may lead to cognitive impairment due to inhibition of angiogenesis. However, data on its impact on neurocognitive function in desmoid tumours (DTs) is lacking. Methods: We conducted a cross-sectional study enrolling 50 participants including 30 with DT on sorafenib (Group 1), 10 treatment-naive patients with DT (Group 2) and 10 healthy controls (Group 3). Questionnaire-based assessment was done using appearance anxiety inventory, Depression anxiety and stress questionnaire-21 (DASS-21), Hindi mental status examination (HMSE) and computer-based Cambridge neuropsychological test automated battery (CANTAB) neuropsychological tests. Statistical analysis was performed using GraphPad Prism software version 10 and individual groups were compared using Kruskal-Wallis test with p value of <0.05 considered significant. Results: 50 participants had a median age of 29.91 years (25%-75% CI: 27.05-32.77 years), female predominance (n = 26, 52%), median duration of sorafenib 18.1 months (range: 6-60) at a median dose of 241.17 mg (range: 200-400). There was a statistically significant difference in anxiety (p = 0.0127) between Groups 1 (patients on sorafenib) and 3 (healthy controls), while other objective cognitive and neuropsychological parameters were comparable. There was a significant positive correlation between sorafenib duration and anxiety (p = 0.026) by DASS21, and a negative correlation between HMSE and mean five choice reaction time (p = 0.04). Conclusion: This is the first study to examine the neurocognitive effects of sorafenib in patients with DT. We exhibit significantly higher anxiety in patients with DT on sorafenib as compared to healthy controls. There was a significant correlation noted between anxiety and treatment duration. We propose further longitudinal studies to assess the effect of sorafenib in DT.