Professor Hope Rugo – UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, USA
Professor Debu Tripathy – The University of Texas MD Anderson Cancer Center, Houston, USA
Professor Nadia Harbeck – Klinikum der Universität München, Munich, Germany
Dr Steven Isakoff – Harvard University, Boston, USA
HR: Hello, I’m Hope Rugo from the University of California, San Francisco’s Comprehensive Cancer Center and we’re here with ecancer at the 2018 San Antonio Breast Cancer Symposium to talk about an area very important to our patients with breast cancer, both in the early and late stage setting – scalp cooling to prevent chemotherapy-induced alopecia. Here with me today are my esteemed colleagues, Debu Tripathy from UT MD Anderson Cancer Center and Professor Nadia Harbeck who is from the University of Munich in Germany and Dr Steven J Isakoff who’s at Mass General Hospital Cancer Center. Thanks for being here. Everybody here has experience with scalp cooling in the care of their patients who are being treated with chemotherapy and one of the things that we wanted to do in this session is to talk a little bit about the issues that breast cancer patients face regarding treatment options and adverse effects and what kinds of things influence them and then the progress we’ve made in trying to address particularly chemotherapy-induced alopecia. So we’ll start and just get a feeling from everybody about their experiences in practice about what the most important issues that patients face and mostly we’re thinking about patients with early stage breast cancer, although certainly in my practice it’s a big issue for patients with metastatic disease as well. Steve?
SI: In our practice obviously hair loss is a critical issue for patients. There are a number of studies showing that a number of women, up to 8%, will actually decline chemotherapy because of the risk of alopecia. So at our institution we started scalp cooling, initially patient driven – about four years ago we had our first patient come to us and ask if they could do this. We were very supportive of that and one of the challenges has been obviously that when patients do this themselves it was fairly labour intensive and then about eight months or so ago we obtained our machines and started a scalp-cooling programme. The uptake has actually been quite good, we’ve had at our hospital now almost 60 patients in the last eight or nine months elect to do this. Even in patients where it hasn’t worked or even patients who have declined the option to do it, they’ve expressed a real gratitude that this was even an option and that we’re thinking about this because it’s such an important issue to them.
HR: One of the big issues that face women who are looking at a diagnosis of breast cancer in the early or late stage setting is a tremendous loss of control so maybe that’s a big part of this as well as just a sense of normalcy. Do you find also in Germany that patients are concerned about hair loss?
NH: Yes, I think they’re afraid of chemotherapy and hair loss is one of the biggest issues for them so we started scalp cooling a couple of years ago. Interestingly enough, the objections came also from the nurses because we have a couple of older nurses in our ward who still remember the old days of scalp cooling with the incredibly big machines that made a lot of noise and didn’t really help patients much. So they were quite reluctant and we started with the more modern systems and actually we started to convince our nurses and the patients really loved it. My take-home message from my first experience over the first year is that it’s critical that the nurses have a good attitude towards it because they are the ones fitting the caps, helping the patients, talking to the patients, so if they’re convinced that it’s helpful the patients have an easy time getting used to a little bit more precooling and then post-cooling time. So it’s critical that the whole team is behind it but particularly the nurses.
HR: It’s really true, certainly at our centre having the nurses be on board was critical because there were two reasons why they weren’t on board – one, they were very suspicious that it wouldn’t work or be bad or people have terrible headache, whatever. That just requires a little experience for convincing but there’s a second issue for our nurses which was the concern about an additional amount of work per patient and how they would fit that timing in. We actually dealt with that by having medical assistants help out as well as people who have graduated from college who are coming to work with us in research for a couple of years will take on that kind of support project along with their research.
NH: I think that’s a very important point. We started to have one scalp-cooling day, now we have five scalp-cooling days.
HR: And more machines.
NH: We have a smaller room with the machines so the patients that don’t get scalp cooling, like we also treat gynae patients, they don’t also want to do this and ask a lot of questions. So we have this in a separate room and it works quite well. You have to plan properly and that’s where the nurses come in as well.
DT: It’s very variable across patients but most patients do want to preserve their self-image and be able to interact with people without maybe knowing that they’re being treated for cancer. Cancer can be very isolating so anything we can do to help patients maintain the normalcy of their life is critical. So we were really happy to be able to start offering this a little less than a year ago and we went through a process to make sure that we worked out the logistics. Many of the things we’ve talked about here are very important for things to run smoothly and it was really good that more safety data came out, more efficacy data came out from randomised studies that gave us a sense as to how effective it is and if there’s any safety or discomfort issues that we can know what they are and be able to communicate them to patients. So the field really has moved forward and enabled us and many other centres to do this so it’s really been a big step forward. We always want to do everything we can for our patients and sometimes we get so caught up in the medical advances that we lose sight of some of these things that are very important to our patients and therefore important to us.
HR: Yes, it is fascinating. Certainly when I was a medical student a very long time ago people would use these ice… just put ice together and try and keep their hair which didn’t work very well. But it was a patient also who brought up the whole idea of scalp cooling and why it wasn’t available in the United States except for in one-off situations and started us on the road of trying to get FDA clearance of scalp cooling devices. In that process we have all learned that there are two major different kinds of scalp cooling devices, the manual kind where the patient has to actually change a frozen cap every 30 minutes and the downside is they’re more time intensive, which you’ve also had experience with, and needing a freezer or dry ice. And also the risk, although small, of thermal injury because the cap has to be so much colder when it goes on the head. Versus the now and continuously improving automated devices, which everybody has now at their institutions of our group here, where you have an automated device that can actually be wheeled around, is small, can serve one or, in some situations, two patients and has a cap which can be fitted to the head and has circulating coolants so you can maintain the temperature which avoids the risk of thermal injury, which is great. Although we still have to do the post-cooling time, so scalp cooling does involve more time and certainly the cold sensation for our patients. I’m curious if you have had patients use scalp cooling in the metastatic setting in any of your sites?
SI: We definitely have. When we launched our programme we took the approach that we would not be restrictive and so we actually allowed any chemotherapy regimen for breast cancer and allowed metastatic patients. So we’ve had patients do it with paclitaxel, with eribulin and with some success. If the drug is working obviously this is going to be more than just the typical twelve weeks that one might get in the adjuvant or neoadjuvant setting but if it’s working the patients are also inspired to want to continue. So we have done that and we’ve actually just expanded our programme now to include gynaecologic patients, many of whom have advanced disease and will be getting this with Taxol based therapies.
HR: Yes, the approval now in the US has been expanded to allow patients with solid tumours to use the device which is great and helps our centres.
NH: You mentioned this before, I think we should not think about scalp cooling just for the early breast cancer setting. We also want to start treating all gynae patients; so far we’ve done it in a trial so we have to restrict it to breast cancer patients but in particular in the first line setting patients do not want their whole village or their whole suburb to know that the cancer is back. We usually have a taxane-based regimen in the first line setting and our best experiences are with the weekly paclitaxel regimens, be it with antibodies or just by itself, and that obviously we use a lot also in the first line setting. So scalp cooling is a great way forward but we shouldn’t restrict it to the early breast cancer setting.
DT: We started with breast cancer and really emphasised more the taxane only but we knew that we were going to expand it once we got more experience and we just had to ramp up slowly. So we have, in fact, now expanded; we’re starting to treat patients with gynaecologic malignancies as well and pretty soon we’ll expand it more and more, it’s just really more a matter of logistics. But we want to make it broadly available.
HR: Yes, we recently had a woman with bladder cancer use scalp cooling but they have to, of course, go to a place where the machines are. I’ve had one young woman recently who has gone through multiple regimens of chemo and has never lost her hair and in the metastatic setting incredibly important to her for her kids and her family and maintaining that, at least, little bit of control on quality of life. We certainly have had some challenges in scalp cooling in terms of not just the devices etc. but also the chemotherapy regimens, and we are talking about that a little bit, about taxanes etc. but some of our patients, although I have to say less now than before, receive anthracycline taxane sequential regimens. I don’t think many patients in the US receive anthracycline alone regimens anymore, some places in the world clearly that’s still the case. But we had two studies that led to FDA clearance of two different automated scalp cooling devices, one of the studies included anthracyclines as part of the chemotherapy regimen and one didn’t. That study with anthracyclines was a truly randomised trial out of Baylor, Julie Nangia’s trial. But the interesting thing about that, I thought, was that there was some disappointment in how well the cap worked for anthracycline-based regimens but it was clearly dependent on experience at the site. We’ve certainly had patients who have kept their hair with anthracyclines, do you have experience in that area?
SI: Yes, most of my experience, because our programme is about eight months old, with the device with the manual use we’ve actually had a fair amount of experience over the past few years with actually quite good success. With the devices now, as you’ve well said, there’s a learning curve and our team is getting more used to that, making sure that the cap fits snuggly and that the patient notices that they have even coolness on their scalp I think will make a difference. But we have seen success with it; I always caution patients that success is lower with anthracyclines but we’re certainly happy to try. The other thing I would mention is in patients who still do lose their hair patients will always ask should I get a refund or should I keep going, what I tell them is, ‘Well, if you lose your hair you’re going to have better contact with your scalp and it probably will get it colder and you may actually start to regrow hair before we’re all done with your cycles,’ and we’ve seen that in the past that by the time patients are finished with their taxane as the second treatment they’re already having hair regrowth. So it’s a tricky question about whether to continue when someone has lost their hair. I don’t know if you were going to mention it but there was a recent publication showing the use of scalp cooling to prevent the potential pervasive alopecia that one can see with docetaxel which implies the same kind of finding.
HR: It is interesting, we’ve had one woman who chose not to use it and then she lost her hair and then she got really tired of it because she’s on a metastatic immunotherapy paclitaxel programme. So she started using it again and the one caution, of course, is that you have to really protect the scalp so it’s not too cold very close to the scalp. But of course now she has a full head of hair and she’s still getting chemotherapy. So we all feel like there used to be this idea that maybe your hair would grow back more quickly if you use scalp cooling, which never made any sense to me, but what really is true is that it probably does. You fill in faster, you grow still at the end of your chemo. I don’t know if anybody else has, before we start talking about the papers, experience with anthracycline regimens.
NH: Yes, in the beginning we wanted to try every regimen, our best success rate obviously is with paclitaxel weekly where we have around 90% success rate. You can try anthracyclines and there are some papers. Our success rate was about 30% but there are other papers showing about 50% success rate with anthracyclines. You shouldn’t promise too much to the patient, you say we can try it, like you said, but I cannot promise you. I wouldn’t use it, probably, with dose dense anthracyclines, I don’t think that makes much sense with our experience but with the three weekly regimens. We also had good experience switching, doing the taxane first and then the anthracycline, and patients were able to keep their hair.
HR: I think that’s a really important point because our patients generally receive the taxane first, we do a lot of neoadjuvant therapy when we’re using an anthracycline. What’s fascinating is that it does appear that having experience as the patient, not just as the institution, makes a difference. So if they use the cap during the weekly paclitaxel, we only use dose dense anthracyclines in general in the US, and it doesn’t seem to make any difference whether it’s dose dense or not. So we have had people keep… the definition of success being generally keeping about 50% of your hair, which I have to say you’ve got to tell patients about because that’s not their idea of not losing any hair, but it does help a lot and really makes a difference. In the trials that were done and the trials that have been reported there is universal appreciation of use of the cap or even being just offered the cap, as well as an improvement in some of the patient-reported outcomes, assessment of self etc. Are you using it also with anthracyclines?
DT: We’re just getting started but we did decide to keep a very careful record because we have a comparative effectiveness committee that looks at everything we do. So we do want to be able to report what we’re seeing and also just present to our patients what we’re seeing. So I feel a little more confident that we’re going to see good results. I think we were also a little biased by the differential results that were being reported but we’re looking forward to adding that group of patients.
HR: I was excited to see a number of different abstracts being presented at this year’s San Antonio meeting about scalp cooling. One area that, of course, has been concerning, even after we presented the two trials I heard from very big placed people that there was still concern about scalp metastases because of poor delivery of chemotherapy to the scalp. At this meeting we reported longer term outcome, now with 3-4 year data combined, showing no scalp metastases in the group of patients we treated with one automated scalp cooling device. Certainly that’s generally so far been true although we don’t have the longer term reported outcome from the other randomised trial that started a little bit later. Do you find that data encouraging? Is it encouraging for your patients?
NH: Yes, that’s very helpful because that’s what patients ask. They’re unsure whether it takes away from the efficacy of the chemotherapy for the head and so you can comfort them and say there is no data, we’ve always been saying that. But it was very helpful that you published this data here.
DT: It’s a very rare event so it’s a little bit hard to detect but there is a good bit of older data as well as new data. So it really helps to have all that together. But I agree, there’s really no evidence at this point that that’s an issue but we should keep careful records and continue to do so.
SI: Yes, there’s longer retrospective data from Europe showing that what patients don’t always understand up front is that we actually do see scalp metastases as part of breast cancer at some small percent but the key thing is there hasn’t been any observed increase with scalp cooling. So that’s a message. It’s in the FDA guidance and so we counsel patients about that theoretical risk but I very much emphasise that it’s a theoretical risk and hasn’t been appreciated in any of the studies that have looked at it. Your poster from this session will certainly help support that.
HR: We had done a meta-analysis of those studies also that’s published about a year ago and it also showed miniscule numbers and no difference between scalp cooling or not although obviously these prospective studies are better datasets and we’ll have a lot of data now with the two different trials as well as a number of others. You mentioned earlier about the docetaxel and we all counsel our patients if they receive docetaxel that they may have very slow hair growth related to number of doses and dose intensity. Miguel Martin published some interesting data about that, I don’t know if you want to just briefly mention it a little bit more?
SI: Just briefly, it hasn’t been well appreciated in the United States as much as in Europe in terms of the way the drug labelling is but there is a very low risk of long-term alopecia or pervasive alopecia from docetaxel which I can’t say in my practice I can recall seeing.
HR: I’ve seen it.
SI: I may have had maybe one, but patients about a year or two ago became more aware of this so it’s definitely something we counsel patients about. But a study that was just relatively recently published specifically was trying to look at whether scalp cooling with docetaxel- based regimens could prevent or reduce the chances of developing this. Maybe you can remind us of the actual numbers but it was in several hundred patients that they treated and I was actually surprised that their control rate was higher than I thought for some element of…
DT: About 10%.
SI: Yes, about 10% pervasive but it was no cases with scalp cooling.
HR: One of the things that’s happened over time, of course, we see with everything we do there’s a paradigm shift. So we use less docetaxel in terms of the dose and the cycles now than we used to use: at 100mg/m2 given for four cycles the rate was 10%; at 75mg/m2 given for four cycles it’s lower. But nonetheless using scalp cooling is an effective way to prevent that even in a minority of patients who can have very little hair at one year after finishing their chemo which is a disaster for young women. One of the big issues that we have with scalp cooling in the United States is reimbursement; I’m curious to see how you manage it in Germany and then we’ll talk a little bit about what we do in the US.
NH: There is no reimbursement for that in Germany either. There are some insurance companies who have now started to pick up on the thought that if they pay for scalp cooling they don’t pay for the wig so there is that, that the patient gets a certain amount of money and can spend it either way. What our centres mostly do, since not everybody does scalp cooling, it’s also something to advertise your centre so some centres just pay for the machine or lease the machine and advertise and, indeed, you get patients coming just for the scalp cooling. Some centres make the patients pay per cycle, so about €80-100 is what you pay. Personally we’ve done it so far in a clinical trial and we intend to support this system from the hospital because it’s important for patients and we should not make them pay per cycle. But we’re a university hospital so that’s a different system.
HR: I know, Steven, you’ve been involved in having some philanthropic support for people who can’t pay for it but also are quite aware of the total costs.
SI: We talked at the beginning about the culture shift that had to happen with our nursing staff and actually, for us, in addition to that one of the key things to get the nurses on board and get the institution on board was we wanted to make sure that this was going to be something equitable. We wanted to make sure that if we were going to offer this at our institution, knowing that insurance right now does not cover this, we did not want a financial barrier to prevent patients coming to our hospital to do this. We’ve been very fortunate to have several donors who want to contribute to this and so at our institution we’ve set up an internal plan for patients who meet criteria where financial burden is what’s preventing them. We now actually can support that and pay for that and it’s been very important to us.
HR: That’s great. So the total cost for most patients is capped after a certain number of cycles and ends up between the $2,500 around range in US dollars. There’s also a national foundation that’s also funded with philanthropic funds to support patients who are low income called Hair to Stay which is available online. Debu, are you doing the same sort of thing at your institution?
DT: We have a very similar programme, as you mentioned. It is capped and we have a fund that we use for patients who qualify for it. We’d like to expand it and grow it. At some point we’d really like to have everybody fully covered. We also have a group of advocates that are working with us on a legislative end to see if there can be either some inducement or maybe even legislation so that, just as plastic surgery, reconstructive surgery is covered that this would be covered as well.
HR: And there is huge interest in the US to try and really push for legislation that would require at least some coverage for scalp cooling and certainly the Paxman company has worked a lot on that in collaboration with others in trying to get it into our NCCN guidelines as well. It’s an exciting area because although we’re here at the meeting, we’re talking about immunotherapy and new treatments and all sorts of exciting things, biomarkers, supporting our patients through this experience is an incredibly important part of this, maintaining quality of life and improving the experience. So it’s been a great pleasure to talk to all of you about all the efforts you’re making at your own institutions and worldwide to try and improve the education about scalp cooling and access. Thanks very much.
NH: Thank you.
DT: Thank you.
SI: Thank you.