The Food and Drug Administration this week approved a device to reduce hair loss in women receiving chemotherapy for the treatment of breast cancer. The media attention has been extensive and highly favorable. But taking a closer look at this, there are a couple things, as yet unreported, that have me more than a little concerned.
The machine is a form of a cold cap, and is designed to reduce the blood circulation to the scalp while a woman receives treatment to either reduce the risk of breast cancer returning, or to treat recurrent disease. The theory—which has been around for decades—is that if one reduces the circulation of blood to the scalp you also reduce the circulation of the drugs that can cause hair loss to the hair follicles. The result is that the hair doesn’t fall out, a common and very sad side effect of some chemotherapy drugs.
It is that same phenomenon, reducing chemo’s attack on the hair follicles that has always been the concern, as well: by preventing the chemotherapy from reaching the scalp, are we creating a “safe haven” for tumor cells that may cause a problem years or even decades later?
But that’s only part of the reason for my concern. More important is that the clinical trial for this device excluded drugs that can cause significant hair loss–treatments where some have suggested hair loss is not prevented by cold cap therapy.
According to a story on Medscape, the FDA approval was based on an abstract reported at the American Society of Clinical Oncology meetings in Chicago this past June. That study demonstrated that the use of this device prevented some hair loss in the majority of women who used it. The FDA noted that the women in the study had stage I or II breast cancer, were receiving chemotherapy, and self-reported their experience through pictures showing the degree of hair loss as part of a clinical trial.
The first concern is what the risk might be for the long term. The FDA noted that “the risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare.” If true, that would be very reassuring. However, there’s been no evidence presented for that statement. Long term follow-up—which will take years to complete as part of this study—has not been done. In fact, the study was very short term, only a matter of months. When breast cancer recurs, it can be years or decades later. It’s possible the FDA relied on other evidence such as long term observation studies to reach their conclusion, so we shall see what they may report at a later date.
And now we get to something even more troubling I came across when reviewing the ASCO abstract, and which to my knowledge has not yet been reported.
The study excluded women who received Adriamycin alone or in combination with other drugs as part of their chemotherapy regimen. And although some of the drugs used in the study, such as Cytoxan, can cause hair loss, Adriamycin, commonly referred to as the ‘red devil,’ is the major culprit in causing chemotherapy-related hair loss. Not to have included the caveat that this drug was not tested in this trial is a major oversight in the promotion and coverage of this approval.
And then there is this comment from BreastCancer.org:
“Women who got both an anthracycline and a taxane in their chemotherapy regimen (combination chemotherapy), especially in combination with cyclophosphamide, seem to have the worst results with cold caps, though some of them still kept some of their hair.”
My fear is we really don’t know if the device will do as much for those women who receive the very drug that has the greatest potential for causing hair loss in the first place.
I don’t know why Adriamycin patients weren’t included, or whether the outcomes would have been the same as reported for the other drugs. But it’s a question that must be asked. It is in fact a significant piece of information, and not one that should be buried in an abstract that appeared a number of months ago.
So when doctors and patients have those important conversations about the benefits, risks and expense of using this device they should be fully informed so they can make the best decision for the person who counts most, namely the woman receiving the treatment.
Ultimately, whether women try the device will come down to doctors and patients having conversations about the benefits, risks and expense of using this device. But how can we have that conversation without all of the facts?