SAN ANTONIO — A scalp-cooling system effectively and safely prevented hair loss in more than half of patients with breast cancer, according to results of the SCALP trial presented at San Antonio Breast Cancer Symposium.
The trial — the first prospective, randomized trial of modern scalp cooling — will be used to support an application for FDA clearance of the Orbis Paxman Hair Loss Prevention System (Paxman). If approved, the Paxman system would compete with Dignicap (Dignitana), a scalp-cooling system that received FDA clearance in December 2015.
Julie Rani Nangia
“Adjuvant chemotherapy decreases the risk for breast cancer recurrence. However, it is associated with distressing side effects, including hair loss,” Julie Rani Nangia, MD, assistant professor of medicine at Lester and Sue Smith Breast Center, part of Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said in a press release. “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.”
Nangia and colleagues conducted the trial between December 2013 and September 2016 at seven U.S. centers to assess the efficacy and safety of the Orbis Paxman scalp-cooling system for reducing chemotherapy-induced alopecia.
The analysis included 182 women with stage I or stage II breast cancer who underwent at least four cycles of anthracycline- or taxane-based neoadjuvant or adjuvant chemotherapy.
Exclusion criteria included migraines, anemia, hypothyroidism or other uncontrolled medical conditions.
Researchers randomly assigned women 2:1 to scalp cooling (n = 119) or no scalp cooling (n = 63). Patients in the investigational group were required to wear the device for 30 minutes prior to chemotherapy, during chemotherapy and for 90 minutes afterward.
Endpoints included alopecia, quality of life and device safety.
Nangia and colleagues used Common Terminology Criteria for Adverse Events version 4.0 to assess alopecia at baseline and at designated time points during treatment.
They used the following grading system:
- Grade 0 — no hair loss;
- Grade 1 — hair loss of up to 50% of normal, with no wig required; and
- Grade 2 — hair loss of more than 50% of normal, with wig required.
Researchers used a device comfort scale to assess comfort, and patients completed quality-of-life questionnaires at baseline and after completion of chemotherapy.
A modified intention-to-treat analysis included 95 women assigned scalp cooling and 47 assigned no scalp cooling.
Results of an interim analysis showed 50.5% of women assigned scalp cooling retained their hair, compared with none of the woman in the control arm (P < .0001). Among those assigned to the scalp-cooling intervention, hair retention rates were 65% among those treated with taxane-based chemotherapy and 22% among women treated with anthracycline-based therapy.
Results of the quality-of-life assessment showed that more than 80% of patients rated the device as very comfortable, comfortable or reasonably comfortable — the three highest ratings on a six-option scale — at all time points. After cycle 4, 14.5% of women rated the device as very comfortable, 24.2% rated it as comfortable and 50% rated it as reasonably comfortable.
The most common grade 1/grade 2 adverse events reported by women assigned scalp cooling included headache (11.9% during cycle 1, 10.7% during cycle 2, 1.5% during cycle 3, and 6.5% during cycle 4), nausea (4% during cycle 1, 2.4% during cycle 2, 1.5% during cycle 3, and 1.6% during cycle 4), and dizziness (3% during cycle 1, 1.2% during cycle 2, and 0% in cycles 3 and 4).
“Further studies should be conducted exploring this technology for other tumor types and for other chemotherapy regimens,” Nangia said during a press conference. “More studies looking at the impact of chemotherapy-based alopecia on psyche and body image should be performed.” – by Jennifer Southall
Nangia JR, et al. Abstract S5-02. Presented at: San Antonio Breast Cancer Symposium; Dec. 6-10, 2016; San Antonio, Texas.
Disclosure: The study was funded by Paxman. Nangia reports no relevant financial disclosures. Please see the abstract for a list of all other researchers’ relevant financial disclosures.