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<0.05. Results: From January 2014 to March 2019, a total of 280 patients were randomized to either the cryotherapy arm (n=141) or the control arm (n=139). The median age was 54 years (range 27-78). The mean cumulative dose of docetaxel was 471 mg (range: 150-660 mg) in the cryotherapy arm and 467 mg (range: 176-600 mg) in the control arm. Docetaxel dose reduction was required in 28 patients (21.9%) in the cryotherapy group and 30 patients (24.6%) in the control group. Frozen gloves were worn by 119 patients (84%) during all three courses of docetaxel, by 126 patients (89%) during two courses, and by 139 patients (99%) during one course. In the intention-to-treat population, cryotherapy significantly reduced the incidence of grade ≥ 2 nail toxicity at week 8 after the final docetaxel dose (18% vs. 37%, p < 0.001), as assessed by the investigators. This decrease was observed in both hand (13% vs. 29%, p = 0.002) and foot (12% vs. 24%, p = 0.011) nail toxicities. These results were supported by evaluations from a dermatologist blinded to treatment, showing a significant reduction in the DNT score for the cryotherapy group at week 8 (29.4 [95% CI, 17 to 41.8] vs. 54.9 [95% CI, 42.7 to 67.2]; p < 0.001) and at week 24 (9.5 [95% CI, 3.1 to 22] vs. 22.8 [95% CI, 10.3 to 35.3]; p = 0.025). Severe discomfort and pain were reported by 41% and 35% of patients wearing frozen gloves, and by 43% and 42% of patients using frozen socks, respectively. PROs revealed no significant differences in quality of life between the treatment arms at weeks 8 and 24. Discussion: Cryotherapy effectively reduces the incidence and severity of nail toxicity in eBC patients receiving 3 courses of (neo)adjuvant docetaxel. Although well-tolerated overall, discomfort remains a notable limitation. These findings support cryotherapy as a scalable intervention to improve chemotherapy tolerability. Citation Format: L. Mathiot, C. Poiraud, J. Dimet, L. Ropers, M. Fenot, E. Bourbouloux, S. Abadie-Lacourtoisie, C. El Kouri, V. Delecroix, R. Lamy, M. Noblecourt, O. Cojocarasu, F. Scotté, J. Frenel, F. Priou. 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]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-01-04.