Abstract

12143 Background: Chemotherapy-induced alopecia (CIA) not only impacts physical appearance but may also be detrimental to patient’s psychological well-being. To address CIA, patients often use scalp cooling devices such as the FDA-approved Paxman Scalp Cooling System (PSCS), currently approved at -5°C. This study explores the potential benefits of lower temperatures, -7.5°C and -10°C, to improve the efficacy of PSCS in minimizing CIA. Methods: This prospective study analyzed data from 33 women with stage I-III breast cancer receiving anthracycline and taxane chemo at MSKCC from 12/2019–10/2022. Photography, trichoscopy, and toxicity checks were conducted at baseline, weeks 4, 8 (primary endpoint), end of treatment (EOT), and 24 weeks post-chemotherapy. 23 patients reached week 8, while 10 withdrew prior due to lack of efficacy (5/10), change in treatment (3/10), or anxiety (2/10). Successful hair preservation (HP) was defined as CTCAE v4 grade 0 or 1 alopecia. Results: At baseline, all patients had grade 0 alopecia. At week 4, 81% achieved successful HP (17/21), and at week 8, over half maintained it (53%; 9/17). The majority had HP at EOT (69%; 11/16). At 24 weeks post-chemotherapy, all patients demonstrated continued HP (100%; 11/11) and all evaluated patients at 18 months post-treatment had grade 0 alopecia (100%,4/4). Among women with baseline photographs and trichoscopy (n=25), median average hair count at baseline was 154.0 per cm² and width 70.2 per cm². By week 4 (n=21), the median average hair count decreased by 20.0%, and width decreased by 8.0% compared to baseline. By week 8 (n=17), average count improved by 15% compared to week 4 (-3% from baseline) and average width decreased by 6% (-7.5% baseline). At EOT hair count decreased 37.8% and width decreased by 11.6% compared to baseline (n=16). At 24 weeks post-EOT there was a 13% increase in median average hair count with no measurable change in width compared to baseline (n=12). No patients (0%; 0/33) reported dose-limiting toxicities (DLTs) at -7.5°C (n=7) or -10°C (n=26). Conclusions: Patients successfully tolerated scalp cooling at lower temperatures, with no reported dose-limiting toxicities and successful HP. This study indicates higher HP rate at EOT (69%; 11/16) compared to studies using PSCS at -5°C. Post-EOT data shows successful hair regrowth with a higher average hair count than pre-treatment. A larger sample size is needed to assess the additional benefit of lower temperatures on HP and regrowth. Clinical trial information: NCT.[Table: see text]

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