Scalp cooling devices that allow patients treated with chemotherapy to retain their hair are used more commonly in Europe than in the United States, but this may be about to change now that the FDA has approved 2 scalp cooling devices: the DigniCap (approved in 2015) and the Paxman scalp cooling device (approved in 2017). At the recent 2017 Annual Meeting of the Multinational Association of Supportive Care in Cancer (MASCC), speakers presented evidence from the pivotal trials associated with these devices and discussed implementation of scalp cooling in the United States.
The approval of the 2 devices is good news for all cancer patients treated with chemotherapy, especially those with breast cancer. In surveys, breast cancer patients cite alopecia as their number 1 fear prior to undergoing chemotherapy.
The SCALP (Scalp Cooling Alopecia Prevention) trial is the first randomized trial in the world to evaluate modern scalp cooling. The study, funded by Paxman, evaluated the Paxman device in 236 women with stage I/II breast cancer receiving neoadjuvant or adjuvant chemotherapy at 7 different sites in the United States from December 2013 to September 2016.
“Scalp cooling devices are highly effective,” said lead author Julie R. Nangia, MD, Baylor College of Medicine, Houston, TX. “Scalp cooling devices work better with taxanes than with anthracyclines. Hair retention rate with taxanes was 65% in the SCALP trial, compared with 15.6% for anthracycline plus taxane. After completion, hair retention rate was 46.2% for the whole group.”
Women were randomized in a 2:1 ratio to scalp cooling or no scalp cooling and were assessed for alopecia (grade 0-3, in ascending order of severity), quality of life (QOL), and device safety. Participants were fitted with a cooling cap at baseline and wore it 30 minutes prior to chemotherapy, during chemotherapy, and 90 minutes afterward. Patient-reported comfort was assessed on a 5-point scale ranging from “very comfortable” to “very uncomfortable.” QOL was assessed by 3 questionnaires, including EORTC Quality of Life Questionnaire-C30, Hospital Anxiety Depression Scale, and Body Image Scale, at baseline, after 4 cycles of chemotherapy, and at completion of chemotherapy.
Final analysis of SCALP was presented for the first time at MASCC by Dr Nangia.
Mean age of patients was 50 years; 80% were white, 13% black, and 5% Asian. Thirty-seven percent had anthracycline-based chemotherapy and 63%, taxane-based.
In a modified intent-to-treat analysis that included 130 women randomized to the device and 54 women to controls, 53% of women wearing the cooling device retained their hair versus 0% of controls (P = .001). Analysis according to regimen found that 65% of women treated with taxanes retained their hair compared with 24.1% treated with anthracyclines.
The most common adverse events related to the device were headache (4.8% at cycle 4) and nausea (1.2% at cycle 4).
“Most participants rated the device as reasonable and comfortable,” she said.
At cycle 4, a total of 66.7% rated it as “very comfortable” or “reasonable and comfortable.”
No significant differences were observed between the 2 groups on all 3 QOL instruments. Dr Nangia emphasized the need for specifically tailored QOL tools to evaluate alopecia.
“We treated the first patient with the device at Baylor on June 1,” she told listeners.
Hope Rugo, MD, Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco (UCSF), reviewed results from the pivotal trial for approval of the DigniCap, which were previously presented and subsequently published (JAMA. 2017;317:606-614).
Dr Rugo explained that although scalp cooling was accepted in Europe, in the United States there was concern about the potential for scalp metastases. Recently, Dr Rugo and colleagues published a meta-analysis showing that the device is safe (Breast Cancer Res Treat. 2017;163:199-205).
The pivotal trial was a study of 106 patients with stage I/II breast cancer compared with 16 matched controls who elected not to use scalp cooling during chemotherapy.
The primary end point was hair loss 1 month postchemotherapy. No patients in the scalp cooling group received anthracyclines. Docetaxel-cyclophosphamide was the most popular regimen (75% of scalp cooling group, 62% of controls).
According to patient self-reports at 4 weeks, 66.3% of patients in the device group reported success and hair retention (measured by hair loss of ≤50% on the Dean score) compared with 0% of controls (P <.001).
QOL according to validated instruments not specific for alopecia showed some improvement in body image and feelings of distress in the device group versus controls. The percentage of patients feeling less physically attractive after scalp cooling was 27.3% compared with 56.3% in controls. Four patients (3.8%) in the scalp cooling group had headache, and 3 (2.8%) discontinued the device due to feeling cold.
Scalp Cooling Implementation in the US
The Penguin device, a manual device, was the only option for scalp cooling prior to the 2 devices now approved by the FDA. The Penguin device requires freezing prior to use and refrigeration when not in use. About 90% of patients had to pay for it themselves. Penguin Cold Caps have been used in the United States for 15 years. These devices are made in the United States and rented directly from Penguin for a cost of about $500 per month.
“With the 2 new devices that are much easier for patients to use, we have few patients opting for Penguin,” Dr Rugo said. “It is harder to take the Penguin cap on and off, and it is colder when you put it on the scalp.”
Dr Rugo said that at UCSF they are using the DigniCap in about 20 patients per month. Medical assistants are the primary personnel involved in this effort. They have 2 units that are almost completely booked and plan to start a third unit.
There is no universal coverage for the device or a unique CPT code yet. DigniCap has had some success with individual reimbursement through several insurers, including Blue Cross Blue Shield, Aetna, and Horizon, ranging from $50 to $400 per treatment.
Patients in the United States are offered scalp cooling through their provider, and then the patients pay for their own cooling cap and treatments through the Paxman Hub. Paxman is currently at 6 sites in the United States, with the price of treatment capped at $2200. The price for the cap alone is $500, and they are currently discarded after use. Dr Rugo hopes that a recycling program will be put in place.
Additional considerations with scalp cooling devices include optimizing chair time and post cooling time, cost to the patient and the infusion center, and cap fitting. Insurance and coverage is an issue. HairToStay is a nonprofit organization that provides subsidies for patients who could otherwise not afford scalp cooling, and private foundations have also helped cover the cost.