SAN ANTONIO – A scalp-cooling system called Orbis Paxman Hair Loss Prevention System (OPHLPS) appears safe and efficacious in preventing chemotherapy-related alopecia in women with breast cancer, a study presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) has shown.1
“Adjuvant chemotherapy decreases the risk of breast cancer recurrence. However, it is associated with distressing side effects, including hair loss,” said the study’s lead author, Julie Rani Nangia, MD, an assistant professor of medicine at the Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX. “In Europe, scalp-cooling technology has helped many patients avoid hair loss and maintain their quality of life, and there is a great deal of interest in scalp-cooling in the United States.”
To evaluate OPHLPS, researchers enrolled 235 women with stage I to II breast cancer planning to undergo anthracycline- or taxane-based chemotherapy for at least 4 cycles.
Participants of the SCALP study were randomly assigned 2:1 to receive either scalp cooling or no scalp cooling. Patients in the scalp-cooling group used the OPHLPS prior to, during, and after chemotherapy sessions.
Results of an interim analysis showed that 50.5% (95% CI, 40.7-60.4) of patients in the scalp-cooling group had hair preservation compared with 0 patients (95% CI, 0.0-7.6) in the non-cooling arm (P < .0001). Adverse events, which included nausea, dizziness, and headache, were mild.
In addition, most patients rated the device as reasonably comfortable and few found the scalp-cooling device to be uncomfortable.
“Scalp cooling devices are highly effective and should become available to women with breast cancer receiving chemotherapy. Based on the results of this study Paxman Ltd will file for FDA clearance of this device,” Dr Nangia said. “Further studies should be done [to explore] this technology for other types of tumors and with other chemotherapy regimens. More studies looking at the impact of chemotherapy-induced alopecia on the psyche and body image should be performed, as well.”
1. Nangia JR, Wang T, Niravath PA, et al. Scalp cooling alopecia prevention trial (SCALP) for patients with early stage breast cancer. Paper presented at: 2016 San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, TX.