Abstract PS1-01-04: Efficacy of cryotherapy using frozen gloves and socks to prevent docetaxel-induced onycholysis in early breast cancer patients undergoing sequential (neo)adjuvant (F)EC and docetaxel treatment: The Banquise randomized controlled trial

Abstract Background: The use of docetaxel in the (neo)adjuvant treatment of early-stage breast cancer (eBC) is frequently linked to notable nail toxicities, which can negatively impact quality of life (QoL) and potentially lead to treatment delays. Cryotherapy, involving the use of frozen gloves and socks, is used as a strategy to decrease docetaxel-induced nail toxicity. Strong evidence supporting its efficacy at lower cumulative doses of docetaxel and its overall tolerability remains limited. Methods: BANQUISE trial was a randomized, open-label, multicenter study investigating the efficacy of cryotherapy in eBC patients receiving three cycles of (neo)adjuvant docetaxel (100 mg/m2) following three cycles of (F)EC 100. Participants were randomized after completing three cycles of (F)EC to either the cryotherapy group, with frozen gloves and socks applied 15 minutes before and removed 15 minutes after the docetaxel infusion, or to the control group. The primary endpoint was the incidence of nail toxicity grade ≥ 2 between the first dose of docetaxel and eight weeks after the last dose of docetaxel, assessed using CTCAE v4.0 criteria by investigators. Secondary endpoints included a docetaxel nail toxicity (DNT) score assessed by a blinded dermatologist at weeks 8 and 24 using photographs. This score integrates the CTCAE V4.0 grade and the number of affected fingers, assigning 1 point per digit for grade 1 toxicity and 5 points per digit for grade 2 toxicity. Cryotherapy tolerability, and patient-reported outcomes (PROs) were measured at each cycle and week 8 and 24 after last dose of docetaxel by the EORTC QLQ-C30 and BR23 questionnaires. Statistical analyses used chi-squared and t-tests, with significance set at p