DR LOVE: You mentioned the issue of hair loss. And you brought in a case today, a 36-year-old lady who was diagnosed actually while she was pregnant. Maybe you can talk a little bit about her. And I’m particularly interested, I see that she got the DigniCap scalp-cooling device. What happened there?

DR HURVITZ: Yes. So she was pregnant and delayed the lumpectomy. So she had a 1-cm tumor that grew to about 3 centimeters by the time she had the lumpectomy. It was ER-positive. And HER2 was one of these funny HER2-positive cases. The ratio was less than 2, but the copy number was greater than 6. And so she started on chemo with the TCH regimen and received 6 cycles.

And at the beginning of that therapy, actually enrolled in the DigniCap study, which Hope Rugo actually got me involved in, because she’s at UCSF and I’m at UCLA, and there’s this network where we’re trying to collaborate and do more clinical trials together. So the DigniCap study, they actually have this scalp-cooling device that is not basically putting an icepack. It’s a cooling device, actually a machine that the patient is connected to. It’s like a very, very tight swimmer’s cap that patients wear.

And the study was designed to compare doing that to patients who do nothing, who choose to do nothing. So it wasn’t a randomized study. There was just a cohort of patients who said, “I’m just going to lose my hair.” This did not evaluate anthracycline-based regimens. It was either the TC regimen or TCH regimen. And it looked at the hair loss pattern using the Savin scale, quality of life, kind of patient-reported outcomes surveys, a lot of scalp examination.

And it was interesting, because I have a lot of experience using the Penguin Cold Caps clinically. And you see maybe, in my estimation, 70% to 80% of patients will have a lot of hair thinning, but they look fairly normal. If you try to put their hair up, you would see a ton of thinning, but they look fairly normal. With DigniCap, you’d see a lot more of the thinning during chemotherapy. It was a lot more noticeable, in my own estimation, but the hair growth back was a lot faster. Now again, that’s my assessment of what I saw in the patients I put on the study. But patients did do quite well in terms of having the hair growth coming back.

And there looks like an FDA approval for this device. And now the trick is getting it into centers. And you have to have space for it. And you have to have a backup machine. So kind of from the clinical perspective, there’s a lot to figure out.

DR LOVE: Yes. I think the most interesting evaluation of that study was the photographs, because just looking at these pictures, they told the story.

I’ve heard a lot about this question of inconvenience and discomfort. How much is there? And how would you compare these 2 systems from that point of view?

DR HURVITZ: I think the days become quite long for patients. So instead of having a 4-hour chemo infusion and going home, you end up being in the clinic all day. And you can’t be in the exact infusion chair. They have to figure out where to put you after the infusion, because, as you can imagine in an oncology practice, you don’t want your infusion room chair being used up by a patient who’s sitting there with an icepack on their head or a cooling device, because that’s not cost effective.

The discomfort is — it’s cold. And so patients generally have blankets and kind of do those sorts of measures to keep themselves warm — not usually pain. Probably a little more discomfort in terms of that with the traditional Penguin Cold Cap. But the fitting of the cap, the DigniCap, is pretty critical. Like, you have to make sure they are no bubbles between the cap and the scalp. You need to have somebody who’s skilled at doing the fitting. So it’s not just something that the infusion nurse would slap on the patient and let them go. It’s fairly sophisticated. So I think that’s going to have to be worked out as well.

DR LOVE: Do you see these strategies being mainly used in the early disease, adjuvant/neoadjuvant setting, or just as much in metastatic?

DR HURVITZ: I’ve had a couple of patients who’ve done it in metastatic setting as well when they’ve had to go on taxane-based or eribulin-based therapy. None of these things are covered by insurance. So it really is a cost issue. Patients are paying out of pocket. And it tends to be my younger patients who are moms or career women who want to stay looking as much like themselves as possible.

DR LOVE: What’s it cost?

DR HURVITZ: So for the Penguin system, which is the traditional one, it’s on the order of $1,500 to $2,000 for a whole regimen of adjuvant chemotherapy, on the order of 3 to 4 months. The DigniCap system is being worked out, is my latest understanding, is the cost is being worked out at this point.

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