Abstract S5-02: Scalp cooling alopecia prevention trial (SCALP) for patients with early stage breast cancer
Authors: Nangia JR , Wang T , Niravath PA , Otte K , Osborne CR , Papish S , Holmes FA , Abraham J , Goldfarb S , Courtright JG , Paxman RJ , Rude MB , Hilsenbeck SG , Osborne CK , Rimawi MF 
Published: March 2017

Abstract
Background
Adjuvant chemotherapy decreases the risk of breast cancer recurrence. However, it is associated with distressing side effects, including alopecia. Women consider chemotherapy-induced alopecia as one of the most severe side effects. In many countries, scalp cooling is used to prevent chemotherapy-induced alopecia. It causes cutaneous vasoconstriction, which reduces blood flow to hair follicles during peak plasma concentrations of the drug and may reduce cellular uptake of these agents. It also results in reduced biochemical activity, which makes hair follicles less susceptible to the damage of chemotherapy. There are no randomized trials assessing this approach with modern scalp cooling and success rates in non-randomized trials have varied.
Methods
We conducted a multi-center randomized non-blinded controlled prospective trial to evaluate the safety and efficacy of the Orbis Paxman Hair Loss Prevention System (OPHLPS) in reducing chemotherapy-induced alopecia. Women with stage I-II breast cancer planned to receive neoadjuvant or adjuvant anthracycline- or taxane- based chemotherapy for at least four cycles were eligible. Participants were randomized in a 2:1 ratio to scalp-cooling or no cooling. Scalp-cooling was done using the OPHLPS 30 minutes prior to, during and 90 minutes after each chemotherapy. The primary efficacy endpoints were hair preservation, defined as CTCAE 4 alopecia &lt;2 (assessed by an independent and blinded evaluator), and device safety. We planned to enroll 235 patients to provide 85% power to detect a 20% difference in hair preservation (i.e. 15% with no cooling and 35% with scalp-cooling). Secondary endpoints included wig/scarf use and quality of life assessed by the EORTC QLQ-30, HADS and BIS. Participants will be followed for 5 years post-study for time to first recurrence, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. One interim analysis was planned to allow the study to stop early for efficacy (superiority) after 95 and 47 patients were enrolled to cooling or no cooling, respectively, and have been evaluated for the primary endpoint. To maintain the overall type 1 error rate, an O'Brien-Fleming spending function has been used to set the superiority boundaries (interim boundary was calculated as p=0.0061 (or Z=2.509)).
Results
This is the first prospective randomized trial with modern scalp cooling in the world. At the time of the interim analysis, 95 patients in the cooling group and 47 patients in the no cooling group were evaluable and had completed 4 cycles of chemotherapy. Among them, 48 (50.5%) out of 95 in the cooling group and 0 (0%) out of 47 in the no cooling group had hair preservation. The one-tailed p-value from the Fisher's exact test is &lt;0.0001, which crosses the superiority boundary (p=0.0061). Thus, on 9/26/2016, the DSMB decided to stop the study early and release the results. Our trial shows that scalp cooling using OPHLP is highly effective in hair preservation and should become available for patients who receive chemotherapy for early breast cancer. These data and secondary endpoint analysis data will be presented. We are seeking FDA approval for the OPHLPS.
Citation Format: Nangia JR, Wang T, Niravath PA, Otte K, Osborne CR, Papish S, Holmes FA, Abraham J, Goldfarb S, Courtright JG, Paxman RJ, Rude MB, Hilsenbeck SG, Osborne CK, Rimawi MF. Scalp cooling alopecia prevention trial (SCALP) for patients with early stage breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S5-02.