Hair loss and cancer go hand in hand in most people’s minds. In fact, some women with metastatic disease are sometimes asked why they have a full head of hair if they’re in active cancer treatment: “you don’t look sick” is the undertone.
Last year, the Food & Drug Administration (FDA) approved the first scalp cooling device based on a prospective study presented at ASCO by Dr. Hope Rugo from UCSF looking at its use with taxane treatment. They found 66% hair retention among women using the scalp cooling device. Other countries already use scalp cooling. And there is a body of literature looking at risk, since for liquid tumors, like leukemia, there is concern about a small risk of scalp metastasis, although that is not considered to be a risk for solid tumors like breast cancer.
At SABCS this year, Dr. Nangia presented interim analysis data from the SCALP trial (a clever abbreviation of Scalp Cooling Alopecia Prevention) which is the first prospective randomized trial of patients on chemotherapy. The SCALP trial included patients receiving a taxane or anthracycline based chemotherapy. Anthracycline chemo is associated with more hair loss than taxanes.
Results were so positive that study enrollment was stopped early after 229 women with early stage breast cancer completed the informed consent process between December 2104 and September 2016. Patients were randomized two-to-one—meaning two patients did scalp cooling for every one person in the control arm. After four cycles of chemo, in the group using scalp cooling 50% retained their hair, compared to 0% of control group. Although not presented, Dr. Nangia explained in a separate conversation that for patients on taxanes, hair retention was 65%, similar to the results from Dr. Rugo’s study.
It should be noted that the interim analysis presented data after four cycles of chemotherapy and there may be more hair loss after subsequent treatments. It will be important to see if patients eventually lose hair but just lose it later, after cycle six or eight.
Previously, options for patients who wanted scalp cooling were rather expensive ice packs that needed to be changed out every 30 minutes. This new device being reported on at SABCS circulates a coolant more like a refrigerator. The device is worn 30 minutes before chemo, during chemo and 90 minutes after. It works by reducing blood flow to hair follicles and may reduce cellular uptake of chemotherapy by the scalp. In a separate conversation, Dr. Nangia explained that getting a tight fit is key to getting the device to work and patients in the early stages of the trial experienced more hair loss than those later in the trial.
In her presentation, Dr. Nangia reported very few patients found it to be uncomfortable, and that most found it to be reasonably comfortable. Patients I’ve talked to who have used a cooling cap, including one woman in the UK, have reported it is quite unpleasant and I was surprised to hear theis response on comfort. There were 54 adverse events, all grade 1 or 2. Most common were headaches, nausea, and dizziness and also some reports of scalp pain and dry skin.
Given that the device works through close contact, it would be expected that hair loss on other parts of the body would be unchanged by scalp cooling. I wondered about women’s feelings about having a full head of hair but no eyelashes and eyebrows. There was no data on patient satisfaction with the device.
Dr. Nangia reports the current cost is $1,500-$3,000 per patient for the device that is available. They are currently seeking FDA clearance. There was no discussion about whether this device, which offers competition to the product already on the market, will help bring the price down and make it accessible to more patients.