The most recent scalp-cooling trial that was concluded was done actually in the United States. It was the first ever randomised prospective study done with modern-day scalp cooling, operating out of a number of sites including Baylor College of Medicine which was our lead, Cleveland Clinic, Memorial Sloan-Kettering and then, importantly to me, some of the US community oncology sites. That concluded just before this time last year in 2016 and we had 142 patients in the initial interim analysis, and we did a final analysis on 180 patients. Two to one randomisation, so looking at chemotherapy induced alopecia and the rates between the scalp-cooling arm and the control arm.
What we saw is that over 50% of our patients in the scalp-cooling arm were successful, meaning that the patient had a grading of alopecia of zero or one, and that was very similar from a blinded observer’s point of view, the physician’s point of view, and also, most importantly, the patient’s point of view. We looked also at side effects, so we generally tend to see mild headaches, some dizziness, some scalp pain, and we’re also looking at longer-term follow-ups. It’s got a five year follow-up looking at the patients and trying to assess the safety of scalp cooling, but we strongly believe looking at the retrospective data that we have that the safety of scalp cooling is good.
And then with that five-year analysis going on, there’s the ongoing trials which will be coming out, I guess, around a similar time?
So we have ongoing trials in Germany, with Professor Harbeck at the University of Munich. We should have finished recruitment very soon and we will look to publish that data later in the year. In addition to that we’ve had an ongoing study in Japan, a mulita-centre study, really looking at whether ethnicity makes a difference. We do understand strangely enough the head shapes and sizes make a difference with the efficacy, hence our intense development into new cooling caps to fit lots of different shaped heads. In addition to that we have an ongoing registry; there’s a large group called CHILL which is an international scalp cooling registry, and we’re looking at a collaboration with many countries, looking at benchmarking data and really trying to understand how we can improve what we do, not only in daily practice but actually is there any signals in how to actually improve the levels of efficacy we get with our patients.
Do you think that such a device might have use for… there seems to be a trend at the moment for incorporating quality of life and patient satisfaction, I guess customer satisfaction into the trial?
Yes indeed, it very much is quality of life and supportive care. We did actually look at endpoints of quality of life in our American study, SCALP, and unfortunately some of the quality of life scales we used really didn’t show us any difference in the quality of life of the patient. We tend to put that down to the scales not really being fit for purpose. They’re looking at the whole patient anyway - they may be undergoing surgery, they’re fatigued, so not really focusing on what hair loss means. Again, an international group headed by Carina van den Hurk is actually, I think we’re at phase III now, looking at a tool which is specifically for patients either having scalp cooling or not having scalp cooling, and looking at what chemotherapy induced alopecia means to them.
You mentioned some of the community settings that this was being trialled in as well.
We worked with US Oncology for a number of years and that’s where our SCALP study was carried out, with probably one of the largest recruiting numbers. We don’t have any other ongoing studies in the community setting in the US; we have smaller piloted studies, but more marketing-related.
I guess with all of these ongoing trials and the five year analysis coming up, where would you like to see scalp cooling either understood or incorporated into assessments in care in, say, 2025?
In 2025 I really do believe it will become standard treatment practice, not only with breast cancer but with all solid-tumour cancers. That is the way it has started to happen in the UK, and I do believe with the supporting clinical data that we’ve got throughout the world we will start to see this as routine practice, and I think that’s really important for the patients.