Today we had the opportunity to participate in a panel where we addressed global issues related to breast cancer. My task was to address issues related to clinical research and how we could advance, potentially, clinical research in breast cancer in the future and what strategies, essentially, we need to address to improve the results that we currently have.
At the beginning it is extremely important for us to recognise that breast cancer is an international problem with incidence and mortality rates that are disparate across the world and that a significant number of patients with new cases come from outside developed countries. The actual number is about 60% of new cases and 65-67% of the mortality comes from low and middle income and low-middle income countries.
So with this reality and recognising that we are doing better in breast cancer therapy, data from the US suggests that over the last three decades the mortality in the US related to breast cancer has decreased by 40%. That’s an amazing number and obviously a great success and shows us that we can do it – if we actually take adequate steps in order to do screening, to make early diagnosis and actually apply the correct treatment we actually can curb the increasing mortality that we’re seeing elsewhere and the US is a clear example in that regard.
But besides that, it’s very challenging to address breast cancer research in a global fashion and the point we made during the conference is that we need to recognise that the priorities may differ depending on where you’re coming from. What may be important in Brazil, Argentina or Chile may be completely different from a country in Africa or an Asian country from what the realities in Canada or the US or Western Europe. So, recognising that, we can make lists that are context dependent and the priorities actually will depend depending on where you are coming from. In this regard it’s absolutely important to consider a certain number of different aspects that each individual region may actually prioritise. We made two points specifically in this regard, one of them addressing issues related to real world life data. This is extremely important for us to, from now on, collectively develop clear criteria for real life data because the results of clinical trials do not necessarily apply to clinical practice as they are. Patients that we put in clinical trials are with specific criteria and they are managed in a very specific way. Once we are in clinical practice these criteria don’t necessarily apply all the time and we essentially start doing things that are not exactly what we do in clinical trials. So this translation from these results is extremely important for us to learn what is happening and I gave one particular example. All the guidelines that we have available, ABC4 guidelines, the ASCO guidelines, NCCN guidelines, put it very clearly and we all agree that in a patient, for example, with hormone receptor positive breast cancer that has advanced disease, metastatic disease, in the first line that patient with hormone receptor positive disease should be treated with hormone therapy, with endocrine therapy. However, when we look at what is happening in real life, data from the US, data from the UK, data from other countries in Europe and data from Brazil indicate that from 30-55% of the patients in that specific situation without visceral crisis are treated with chemotherapy showing that there must be some reason why physicians all over the world are not following what should be a very easy guideline to follow. So this kind of information is obviously extremely important and valuable in order for us to move forward in this field, improving quality of life and potentially improving the results.
The other example of real world life that I gave is related to trying to essentially globally to de-escalate the results or the therapy that we are giving to our patients. If we look at what we have been doing over the last few years, the last few decades as a matter of fact, with adjuvant treatment is that we are treating patients exaggeratedly. Most patients that we treat with the adjuvant therapy do not benefit or do not need the therapy. One example that was given was where the efforts that have been done so far with trying to de-escalate treatments with trastuzumab, trying to bring the one year adjuvant trastuzumab to six months or less treatment. Nine to six months, the studies have been addressing those kinds of durations. So far the three studies that have been performed were academic studies, difficult to conduct and they were not able so far to clearly demonstrate that less trastuzumab is equivalent to twelve months of the medication. Obviously this has something to do with patient selection – there are some patients that actually do not need the trastuzumab, some patients that actually can be treated adequately with six months and some patients that actually do require the twelve months treatment. So we don’t have the ability so far to identify these different patient populations. In this meeting the PERSEPHONE trial will be presented next Monday and allegedly this trial, coming from the UK, actually proves that some patients in this situation can be safely treated with six months of trastuzumab. That’s an extremely important result and, if confirmed, will have a significant impact not only in the quality of life, the toxicity, the tolerability and the economic aspects of treating patients in this situation.
In summary, moving breast cancer research into the future will necessarily imply collaboration of different players and certainly paying attention to what context dependent realities we have in different regions in the world.