Taking place, there are quite many in development, there are some which are about to be launched and starting accrual. So let’s start with first the one with accrual starting. The first one is Appalaches which is a trial addressing the question of de-escalation of the aggressivity of the treatment in the post-operative setting in breast cancer after surgery for older patients. Meaning that above 70 the difficulty is that very often to deliver chemotherapy brings also a certain number of side effects which are more difficult to handle or to tolerate in the older population. So there is a clear wish or interest in trying to waive the burden of chemotherapy and to find some new strategies with no chemotherapy and replacing chemotherapy with more targeted treatments. That’s the aim of Appalaches which is going to address in a randomised way adjuvant chemotherapy versus no adjuvant chemotherapy but replaced in this case with a combination of endocrine therapy plus CDK4/6 inhibitors – palbociclib.
What are some of the clinical implications of these studies?
That’s very important to realise that very often our clinical research is led in groups which are not matching completely with reality which gives us a skewed image of the routine population that we treat. Especially in cancer where there is a constant ageing of the population that we address in our practice. So these kinds of questions which are difficult to lead in older patients because of comorbidities, because of colliding interests or challenges, to run such trials is very important to show that we need to change and to evolve in terms of how we build clinical research today to match better reality.
So that was the case of Appalaches; another one, there are at least two trials in development that we will speak about tomorrow. One is for older patients again to try to better match the reality of this population and to show that we need to develop innovation differently. That’s a trial which will address the combination of endocrine therapy again plus CDK4/6 inhibitors showing that to go for a stepwise approach dose escalation strategy is certainly better in terms of protecting or trying to avoid important side effects.
The second one is a trial which wants to address a question also of de-escalation of aggressive treatments but in the general population in the neo-adjuvant setting in selecting those patients in whom the targeted therapies might be even more active. So that’s not randomised, that’s a phase II trial which is going to try to address the combination of PARP inhibition and immunotherapy in the neoadjuvant setting, chemo-free regimen, for TNBC, triple negative breast tumours, with BRCA mutations.
Can you describe some of the main challenges you are noticing in oncology today?
The main challenge in oncology today is multiplication of subgroups, of small groups of patients better defined because of genetic alterations or some specific aspects. So it has expanded considerably the number of potential questions of interest. So it’s quite challenging to keep updated and able to address all these questions. So that’s the fragmentation of clinical research with smaller numbers for groups of patients of interest.
Then the other one is the collaborations at the international level for which national groups have great roles but need also collaboration across borders in which EORTC plays a major role, in my opinion.
What are some of the primary targets to be achieved in the next few years?
My first one, my first wish, is really to change the perception or to change this gap which exists between standard clinical research led in the younger adult population compared with the growing segment of the population above 70 for which very often we do not have any research questions led or positioned. So we need to think, to make a small revolution in terms of the way we address these things because it means looking at different endpoints, taking into account other goals in life that older patients may have in terms of functionality, in terms of quality of life. It’s repositioning the research question on the patient and with a better match in expectations from the population.
