e15029 Background: BOLD-100 is a ruthenium-based anticancer agent in Phase 2 development for gastrointestinal (GI) cancers (NCT04421820). Previous data showed BOLD-100 plus FOLFOX improved overall survival (OS) and progression-free survival (PFS) in patients (pts) with advanced colorectal (mCRC), gastric (GC), and biliary tract cancer (BTC). Pts treated with the BOLD-100 combination had a lower incidence of oxaliplatin-induced peripheral neuropathy (OIPN). Many pts treated with FOLFOX experience OIPN leading to dose reductions and treatment discontinuations. A retrospective analysis of adverse events (AEs) from this study was conducted to investigate the impact of BOLD-100 on OIPN. Methods: BOLD-100-001 is a prospective, open-label, phase 2 study in pts with mCRC, GC, BTC p = 0.04) and medical history of prior neuropathy (OR = 0.18; p = 0.02) were significantly associated with the absence of OIPN. Univariate analysis suggested longer OS (OR = 1.1; p = 0.006), PFS (OR = 1.13; p = 0.002), and a higher number of cycles (OR = 1.17; p = 0.0003) were associated with an increased likelihood of OIPN. Conclusions: Analysis of safety and dosing data from BOLD-100-001 suggests a potential neuroprotective effect of BOLD-100 against FOLFOX-induced PN. Further investigations are ongoing to characterize this effect in a randomized arm of the BOLD-100-001 clinical trial which is exploring changes in health-related and neuropathy-related quality of life per EORTC-QLQ-30 and EORTC-QLQ-CIPN20 scores. Clinical trial information: NCT04421820 .
O'Kane et al. (Thu,) studied this question.