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 “Scalp cooling devices are highly effective and should become
available to women with breast cancer receiving chemotherapy,” lead
author Dr. Julie Rani Nangia of Baylor College of Medicine in
Houston, Texas, said during a media briefing.
Scalp-cooling technology lowers the temperature of the scalp, which
reduces blood flow to hair follicles and has been shown in other
studies to reduce hair loss in cancer patients undergoing
chemotherapy, she explained.
The Scalp Cooling Alopecia Prevention (SCALP) Trial enrolled 235
women at seven U.S. medical centers. The women had stage 1 or 2
breast cancer and were scheduled to receive at least four rounds of
chemo with anthracycline or taxane, which are known to cause hair
loss.
Patients were randomly assigned to either scalp-cooling with the
still-experimental Orbis Paxman Hair Loss Prevention System (OPHLPS)
or no scalp cooling.
The system features a “cold cap” that is fitted to a patient’s head
during chemotherapy. Cooling was done 30 minutes before, during, and
for 90 minutes after chemotherapy sessions. (See a picture of the
cooling cap here: http://bit.ly/2gpRiuj)
Based on the superior results with the scalp-cooling device, the
research team's safety monitors decided to stop the study and
release the data, Nangia said.
At that point, 95 patients in the cooling group and 47 patients in
the non-cooling group had completed four cycles of chemotherapy.
Forty-eight patients in the cooling group (50.5 percent) retained
their hair, compared with none of the patients in the no-cooling
group.
Side effects were mild and included headache, nausea and dizziness,
Nangia reported. Most of the patients rated the cooling device as
“reasonably comfortable and very few found the scalp cooling device
uncomfortable,” she said.
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Paxman, which makes the OPHLPS system, is now seeking clearance from
the U.S. Food and Drug Administration to market the device. Last
December, the FDA cleared a scalp-cooling system made by Dignitana
Inc, called DigniCap.
Nangia said scalp-cooling technology has been used for other
solid-tumor cancer types in other countries, although it is not
appropriate for patients with blood cancers.
The women in the SCALP trial will be followed for five years to
monitor overall survival, recurrence of cancer and potential
metastasis to the scalp.
Nangia noted that scalp cooling technology has been slower to catch
on in the U.S. than Europe, partly due to concerns about the
potential for cancer spreading to the scalp.
But briefing moderator Dr. Kent Osborne, co-director of the San
Antonio Breast Cancer Symposium and also from Baylor College of
Medicine, said, “We have tons of data from different trials looking
at the site of first recurrence in patients with stage 1 or 2 breast
cancer and I don't think we found a single patient that recurred in
the scalp only, ever.”
“Yes, scalp metastases happen but they always happen in the face of
metastasis everywhere else in the body so we are quite certain given
that and the data from some of the European trials that that's not
going to be an issue,” Osborne said.
SOURCE: http://bit.ly/1HtTtRH San Antonio Breast Cancer Symposium
2016.
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