Hedgehog Inhibitors beyond Clinical Complete Response in Basal Cell Carcinoma: Should i Stop or Should i Go?

Abstract

Introduction: In advanced basal cell carcinoma (BCC), the issue of whether Hedgehog inhibitors (HHIs) should be stopped or not after clinical complete response (cCR) achievement remains an unmet clinical need. Materials and Methods: We conducted a retrospective, multicenter study across 7 Italian dermato-oncology units including patients with BCC who continued vismodegib after cCR between 2012 and 2019. We assessed the relationship between the duration of vismodegib intake (days to cCR [DTCR], days to stop after cCR [DTS], total treatment days [TTD]), and disease-free survival (DFS). Reasons to stop vismodegib were (R1) toxicity and (R2) disease recurrence. The relationship between DTCR, DTS, TTD, and DFS in the whole population and in R1 subgroup was assessed by Pearson's correlation coefficient (P <0.1). The analysis of R1 subgroup (N=50) confirmed these results. DFS correlated with DTS in all recurrent patients (N=38, r=0.44, P 2 months after cCR (mDFS>2 months, N=54 vs.≤2 months, N=14: 470 vs. 175 d, P