OBJECTIVES: Prompt identification of the initial symptoms of Hand-Foot Skin Reactions (HFSR), an adverse effect of targeted cancer therapies, could lead to earlier management, improving quality of life. The FACET study aims to investigate the feasibility and usability of an electronic collection device for early detection of HFSR.

METHODS: This prospective, multicenter, interventional study includes patients with metastatic colorectal cancer (mCRC) who initiated treatment with regorafenib. Eligible subjects received an electronic tablet with an application that records questionnaires (HFS-14, EQ-5D-5L, FAS, VAS), a camera to photograph their hands and feet, and electronic insoles to collect daily activity information. Two 28-day data collection cycles were scheduled. The primary outcome measure was adherence to data collection assessing feasibility and compliance with the tools. A minimum of 15 patients with and without HFSR was expected.

RESULTS: Of 38 regorafenib-treated patients (55% male, median age 65 years), 34 patients (90%) experienced ≥1 adverse event (74% drug-related; 35% Grade ≥3); 2 had insole-related adverse events. Notably, in all 16 patients (42%) with HFSR, drug withdrawal was unnecessary. Study intervention was completed according to the protocol in 56% of HFSR patients vs. 46% of the 22 non-HFSR patients. Early discontinuation rates were 44% (HFSR) vs. 55% (non-HFSR). The median time from baseline to early discontinuation was 44.0 days (HFSR) vs. 21.5 days (non-HFSR). Regorafenib was continued at the end of the study in 75% of HFSR patients (non-HFSR: 68%).

CONCLUSIONS: The use of an electronic device suite for remote early detection of HFSR appears feasible and suitable for regorafenib-treated patients in their daily life. When integrated into clinical care, these devices could enhance treatment compliance and improve potentially the benefit of regorafenib in mCRC patients. Detailed information on patients’ compliance, data specificity, and variables associated with HFSR development will be presented.