SABCS 2016: Scalp-Cooling Device Safe and Effective in Reducing Chemotherapy-Induced Alopecia in Women With Breast Cancer
Although adjuvant chemotherapy decreases the risk of breast cancer recurrence, it is associated with distressing side effects, including hair loss. A prospective randomized trial evaluating the safety and efficacy of the Orbis Paxman Hair Loss Prevention System (OPHLPS), a scalp-cooling device that reduces blood flow to hair follicles, in reducing hair loss in women with breast cancer being treated with anthracycline- or taxane-based chemotherapy has found the device to be safe and highly effective in preserving the patients’ hair. The study results showed that over 50% of the women in the cooling group had hair preservation compared with 0% in the noncooling group. The study (Abstract S5-02) was presented at the 2016 San Antonio Breast Cancer Symposium.
Study Methodology
The researchers enrolled 235 women with stage I or II breast cancer who were planning on receiving neoadjuvant or adjuvant anthracycline- or taxane-based chemotherapy for at least 4 cycles. Participants were randomized in a 2:1 ratio to scalp cooling or no scalp cooling. Scalp cooling using the OPHLPS device was performed 30 minutes prior to, during, and 90 minutes after each chemotherapy session. The primary efficacy endpoints were hair preservation, defined as Common Terminology Criteria for Adverse Events (CTCAE) 4 alopecia < 2, as assessed by an independent and blinded evaluator, and device safety.
Study Results
At the time of the interim analysis, 95 patients in the cooling group and 47 patients in the noncooling group were evaluated and had completed 4 cycles of chemotherapy. Among these patients, 48 of the 95 (50.5%) in the cooling group and 0 of 47 (0%) in the noncooling group had hair preservation (P < .0001). There were 54 adverse events, all were grade 1 or 2 and included headache, nausea, and dizziness.
Seeking FDA Approval
“Scalp-cooling devices are highly effective and should become available to women with breast cancer receiving chemotherapy,” said Julie Rani Nangia, MD, Assistant Professor of Medicine at Baylor College of Medicine in Houston, Texas, and lead author of this study, during a press briefing announcing the study results. “Based on the results of this study, OPHLPS will file for [U.S. Food and Drug Administration] clearance of this device. Further studies should be done exploring this technology for other types of tumors and with other chemotherapy regimens. And more studies looking at the impact of chemotherapy-induced alopecia on the psyche and body image should be performed.”
In 2015, the U.S. Food and Drug Administration (FDA) approved the Dignitana DigniCap Cooling System to reduce hair loss in female breast cancer patients undergoing chemotherapy. Although scalp-cooling systems have been used in Europe for the prevention of hair loss during chemotherapy, the technology had not been available in the United States prior to the DigniCap system because of concern of scalp metastasis, according to Dr. Nangia.
“The way scalp-cooling devices work is they cool the scalp and constrict the blood vessels, and there was concern that there would be a reservoir for cancer cells where you could develop a metastasis in the scalp,” she explained. “This had been seen previously with liquid tumors like leukemia that spread in the blood.” However, large European studies have “demonstrated safety and did not show an increased risk for that metastasis at a single site of recurrence or a decrease in overall survival in the women who have received scalp cooling and those who did not. We will be following all of the participants in this study for 5 years for safety to look for recurrence and overall survival,” she said.
This study was funded by Paxman Cooling. Dr. Nangia declared no potential conflicts of interest.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
