US Food and Drug Administration (FDA) has given marketing clearance for the Paxman Scalp Cooling System for reducing hair loss in breast cancer patients undergoing chemotherapy.
The device becomes the second hair loss prevention system okayed by the FDA following the 2015 clearance of the DigniCap Cooling System.
However, the Paxman scalp cooler is the only one tested in a randomized clinical trial ― the Scalp Cooling Alopecia Prevention Trial (SCALP) ― first reported at a meeting and published earlier this year in JAMA Oncology. It was conducted at a number of major centers, including Baylor College of Medicine, the Memorial Sloan Kettering Cancer Center, the US Oncology Network, and the MD Anderson Cancer Center.
In the trial, 50.5% of the 95 patients randomly allocated to receive the cooling intervention had "success," in comparison with 0% of the 47 patients who did not receive the intervention (P < .0001).
Success was defined as experiencing either no hair loss (grade 0) or loss of up to 50% (grade 1). Thus, patients who experienced air loss of more than 50% (grade 2) did not meet the criterion for success.
However, 63% of women randomly assigned to the scalp cooling group still resorted to wearing a wig or a head wrap (100% of women in the control group wore a wig or head wrap). No differences in emotional or social functioning at the end of chemotherapy were observed between the two groups.
All of the participants were women with stage I-II breast cancer who had received at least four cycles of neoadjuvant or adjuvant anthracycline- or taxane-based chemotherapy.
Notably, hair retention success varied by both the type of chemotherapy participants received and clinician expertise in using the device.
Hair preservation rates were much lower (16%) among women who received an anthracycline-based regimen than among those who received a taxane-based regimen (59%). Furthermore, depending on the center where women received treatment, success ranged from a low of nearly zero to more than 68%, investigators add.
The Paxman device consists of a compact floor-based refrigeration unit that circulates coolant via a tube into a silicone rubber cap that is placed on the head and is adjusted for a tight fit.
"The fit of the cap is key — if you have any gaps, you have hair loss," said investigator Julie Nangia, MD, of Baylor College of Medicine in Houston in a presentation last year.
Both US-approved scalp cooling devices have champions and critics.
About the availability of the two caps, Dr Len Lichtenfield of the American Cancer Society recently said that "a deeper look into the data shows that this welcome news is not nearly as clearcut as it might seem."
Dr Lichtenfield went on to observe that in studies of both caps, "there's not much effect on quality of life," and he cited cost concerns (cost estimates range from $1500 to $3000).
However, the devices, which work by limiting damage to hair follicles and are administered prior to, during, and after chemotherapy sessions, have been praised by other oncologists.
In an editorial published earlier this year, Dawn L. Hershman, MD, from Columbia University in New York City wrote: "[I]dentifying interventions, such as scalp cooling for the prevention of chemotherapy-induced alopecia, that reduce or eliminate treatment-associated toxic effects will help ease the distress associated with chemotherapy and may, as a result, improve outcomes for patients with breast cancer."
The story of the development of the Paxman scalp cooler is one of family loss combined with family technical skill and was first reported by Medscape Medical News in 2016.