In an editorial accompanying two separate studies on scalp cooling devices, both published online Feb. 14 in JAMA Oncology, Dawn L. Hershman, MD, from the Herbert Irving Comprehensive Cancer Center at NewYork–Presbyterian/Columbia University Medical Center, New York City speaks about quality of life for individuals with cancer. The scalp cooling devices are designed to help to prevent chemotherapy-induced alopecia (hair loss) by reducing blood flow to the scalp and thus the amount of chemotherapy delivered to the hair follicles. She said that “[o]ne of the strongest deterrents for a woman who is deciding whether to undergo chemotherapy is concern about alopecia.”
Medscape Medical News says the author of a second editorial, JAMA Oncology web editor, Howard (Jack) West, MD, Swedish Cancer Institute, Seattle, Washington, agreed, and that he told the news source that clinicians failed to pay attention to what matters to patients and, had they done so, they might have done more to prioritize hair preservation during chemotherapy.
“I think many people, especially women, may factor the potential for alopecia into their decision about receiving chemotherapy, and this could potentially lead to patients being undertreated because of their concerns about this side effect,” he said.
The two recently published studies both found that the women who used the scalp cooling devices were able to endure chemotherapy without experiencing as much hair loss as those who did not use the device. In fact, in both studies 100 percent of the women who did not use the device experienced severe hair loss; in one study it was documented that all of the control group resorted to wearing a wig or head scarf and in the other they acknowledged decreased quality of life such as feeling “less physically attractive.”
In the SCALP trial of the Orbis Paxman Hair Loss Prevention System (Paxman Coolers Ltd), which is awaiting approval in the United States, almost 40 percent of the women who used the scalp cooling device didn’t find that they needed to use a wig or head wrap. In the study of the DigniCap, developed by Dignitana AB and approved for use in the United States in 2015, 66.3 percent of the women who used the scalp cooling device experienced 50 percent or less hair loss.
The devices are used similarly, 30 minutes before, during, and for 90 minutes after each chemotherapy infusion, with the DigniCap sometimes used up to 120 minutes after each session. In the SCALP trial the study authors noted, “The fit of the cap is key to successful hair retention with the scalp cooling device.” Lead author Julie Nangia, MD, Baylor College of Medicine, Houston, Texas and colleagues explain, “and there is a learning curve with use of the device; with repeated use, clinicians become more skilled at ensuring a tight fit and there is a higher likelihood of hair retention.”
A significant difference between the two trials is that the SCALP trial included patients being treated with an anthracycline-based regimen when the DigniCap study did not. In the SCALP trial of the 142 evaluable patients 64 percent of women received a taxane-based regimen and 36 percent received an anthracycline-based regimen and the researchers found that rates were much lower (16 percent) among women who received an anthracycline-based regimen than among those who received a taxane-based regimen (59 percent).
This may be good news for any chemotherapy patients who find themselves needing to take Taxotere, a taxane, that is now under fire for putting patients at risk for permanent hair loss. Lawsuits filed against the drug manufacturer, Sanofi-Aventis, allege U.S. patients were choosing this chemotherapy drug without being fully informed of the risk they were taking. They were told that “hair generally grows back,” when users in other countries were warned as early as 2005 that irreversible alopecia could be a side effect of the drug.
“Sanofi-Aventis’s own clinical trials in the 1990s found that 9.2 percent of women with breast cancer who completed chemotherapy with Taxotere, Adriamcycin, and Cyclophosphamide (TAC) reported hair loss that persisted during the 10-year follow-up period,” reported the Daily Hornet.
Now, since in 2015 a warning has been included on the drug’s safety label, and due in large part to the attention that litigation against Sanofi-Aventis has brought to the subject, many people are now aware of the risk they are taking if they choose the drug over another alternative and they are able to make informed choices, perhaps such as to utilize a cooling cap during treatments.
It is possible that the cooling caps’ success, specifically with taxane chemotherapy drugs, reducing the amount of drug reaching the hair follicle, will help to minimize that risk for Taxotere users.