Abstract P2-12-12: Efficacy and safety of scalp cooling (SC) treatment for alopecia prevention in women receiving chemotherapy (CTX) for breast cancer (BC).
Authors: Serrurier KM , Melisko ME , Glencer A , Esserman LJ , Rugo HS 
Published: August 2014

Abstract
Background: CTX induced hair loss (HL) is one of the most distressing side effects of BC treatment. Compared to women without CTX induced alopecia, those with alopecia have reported poorer body image, lower self-esteem and worse quality of life. In some cases, CTX induced HL may affect choice of therapy. Given the emotional impact of HL, the potential benefit of preventing CTX induced alopecia is great. We conducted a registry study tracking safety and efficacy in BC patients (pts) treated at our center who independently elected to use Penguin Cold Cap Therapy (PCCT).
Methods: Pts who chose to use PCCT during CTX for early stage (ES) or advanced (M) disease signed informed consent to participate in the registry. HL was rated by practitioner assessment using the 5 point Dean's scale for HL: grade 0 (no HL), 1 (&lt; 25% HL), 2 (25–50% HL), 3 (50–75% HL), and 4 (&gt;75% HL), and by pt assessment using a visual analogue scale (VAS) from 0–100 where 0 = no HL and 100 = 100% HL. Assessments were every 2–3 weeks at the start of each CTX cycle, and once in follow-up 1–6 months after completing CTX. Additional data collected included pt reported adverse events and pt satisfaction with the success, ease of use, and tolerability of PCCT.
Results: 31 pts (29 with ES and 2 with M disease) have registered. 25 have completed CTX and 20/25 are off study. 6 pts currently on CTX and 2 pts who stopped PCCT after cycle1 due to toxicity of CTX rather than issues with PCCT were excluded from the safety and efficacy analyses due to incomplete data. 2 additional pts were excluded from efficacy analysis due to beginning PCCT after the start of CTX, leaving 21 pts evaluable for efficacy and 23 pts for toxicity. CTX regimens included: docetaxel and cyclophosphamide (TC), docetaxel, carboplatin and trastuzumab (TCH), sequential doxorubicin and cyclophosphamide and paclitaxel, (AC/T), weekly nab-paclitaxel (nab). PCCT toxicities were all &lt; grade 2 and included: 15 pts (71%) with headaches and 5 (22%) with dandruff during PCCT. All pts experienced head pain, and 20 pts (95%) had scalp pain and felt chilled during the PCCT. Table 1 depicts clinician and patient reported efficacy.

Of the 20 pts assessed following completion of CTX and PCCT, 12 (60%) “highly recommend” PCCT, and 8 (40%) “recommend to some degree”. No ESBC pts have worn a wig at any point.
Conclusions: SC treatment (PCCT) is a viable but variably effective method of preventing HL for ESBC pts receiving CTX. The success of SC in hair preservation was dependent on the type and length of CTX regimen. Other patient factors impacting HL may exist. Short term toxicity is minimal. Given the emotional impact of CTX induced HL, ongoing study of PCCT and other SC devices, comparing different CTX regimens, is worthwhile. Ongoing studies at our center will include independently graded photographs to eliminate reporting bias by the clinician.
Support for this trial was provided by the Tauber Foundation.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-12-12.