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Background: Chemotherapy induced alopecia is one of the most distressing side effects of cancer therapy since it is a constant reminder of the underlying malignancy. Anthracycline chemotherapy induces total alopecia. Although scalp cooling devices have been used to prevent this alopecia, there is still a need to improve efficacy with anthracycline therapy. This study was performed to evaluate if the Paxman Scalp Cooling System is safe, tolerable, and more efficacious at lower temperatures. Objectives: The primary end point is to assess the safety and tolerability of the Paxman Scalp Cooling System at lower temperatures (-7.5 Celsius and -10 Celsius), defined as the ability of patients to undergo scalp cooling without any DLTs during the treatment period. The secondary end point is successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade 0 [no hair loss] or grade 1 [< 50% hair loss not requiring a wig] were considered to have hair preservation) after anthracycline chemotherapy. Methods: 34 women with stage I-III breast cancer who were receiving anthracycline-based neoadjuvant or adjuvant therapy were enrolled on study. The first 7 patients received scalp cooling at -7.5 Celsius and the subsequent 27 patients received scalp cooling at -10 Celsius. Patients completed safety and tolerability assessments at each visit. In addition, participants had standardized scalp photography to assess the superior, vertex and frontal scalp views, trichoscopic assessments, alopecia grading and completed PROs (CADS, Tolerability, Change in scalp coverage). Results: Thirty-four women (56% White, 18% Black, 8% Asian, 18% other) with a mean age of 44 (range 20-68) were enrolled on this IRB-approved pilot study. Seventy-four percent received ddAC-T, 18% received ddAC-THP and 8% received ddAC/Pembro-T/Carbo/Pembro. Twenty-six patients were evaluable for the DLT end point. Three patients are still on study and five patients left the study before completion (2 due to lack of efficacy, 1 shaved her head, 1 was removed from study due to hospitalization for sepsis and 1 patient changed her mind and never started scalp cooling). There were no DLTs in any patient throughout the study. Both the -7.5 and -10 Celsius temperatures were found to be tolerable with no difference in tolerability. The most common reported AEs were headaches 48%, discomfort 13%, scalp pain 9.7%, dizziness 9.6%, scalp coldness 6%, feeling cold 3% and lightheadedness 3%. Twenty-nine percent of patients reported that scalp cooling triggered a headache and the average level of pain was mild. Only 16% of patients reported pain killer use due to scalp cooling, which effectively resolved headaches or discomfort. Sixty-one percent of patients reported hair preservation at the primary end point. Hair regrowth was reported in patients after they experienced grade 2 alopecia and while still on study. More detailed data on hair preservation will be forthcoming once all of the photos and trichoscopic measures are assessed. Conclusions: Paxman Scalp Cooling System is safe, tolerable and even more efficacious at lower temperatures. The -10 Celsius is more efficacious and as tolerable as -7.5 in patients being treated with anthracycline therapy. When using the Paxman Scalp Cooling System in patients being treated with anthracycline therapy, you should consider performing scalp cooling at lower temperatures Table 1: Demographics Citation Format: Shari B. Goldfarb, Victoria Blinder, Devika Gajria, Cassandra Chang, Analisa Dacunto, Jinae Park, Monica Fornier, Mario Lacouture. Safety and Tolerability of Paxman Scalp Cooling at Lower Temperatures to Improve Efficacy with Anthracycline Chemotherapy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-08-10. |
