It was just a collection of data of the CML patients that we have. So more than 60, I think 68 exactly, Italian centres decided to share all the data in their possession concerning the CML patients that they are following in order to have a view of what is happening in real life clinical behaviour and practice. This is extremely important because most of the studies, most of the data that we have on CML, are just obtained from clinical studies or trials reported spontaneously sometimes but more frequently just provided, sponsored, by companies and so on in which some patients are excluded because of some of the things that are not considered in the protocol relevant.
So in this case we have collected really all the cases of CML which have been diagnosed in our centres. This, in our idea, was just that this is something which is really corresponding to what is happening to our patients and what can be their outcome and, of course, also in part their expectation in real life clinical practice.
What endpoint did this analysis evaluate?
The endpoint was, in particular in this first analysis because we are planning to have many more analyses in the future, is just to see which is the survival and which are the factors predicting for survival of the CML patients. So we have considered more than 2,500 patients, we have seen their weight, their age, their honographical [?] data of course is very important, and we have considered also the way in which they have been treated or at least started their first line therapy. In this way we’ve got important information about which is the best way to establish the prognosis and, on the other side, what we have to fear or to be careful about and what probably is not so relevant.
What were the key results?
First of all, the overall survival is extremely good because the overall survival of all the patients after five years is almost 85% of the patients. What is really important is that the major cause of death is not represented by the CML but by other causes. Indeed, CML represents only one-fourth approximately of the deaths and these are mainly occurring where the patients are undergoing a progression of the disease.
Whereas, indeed but this is quite rarely occurring and the fact that CML is responsible for the death of the patients is only present, as I told you, in one-fourth of the patients and therefore is roughly less than 2-3% of all the CML population.
How can these results impact the future treatment of chronic myeloid leukaemia patients?
First of all, I would say that it’s very important to know that there are still some patients unfortunately dying also of CML, although few, as I said before. But we must particularly concentrate our attention on these patients. We can identify them, I would say, in a good way using the new scoring system that has been developed by the EUTOS programme which is a modification of the so-called risk in which the patients are subdivided in a low risk, intermediate risk and high risk. Fortunately enough, according to this new classification of the patients those in the high risk group who are those that more frequently can undergo a progression of the disease are representing only 10-15% of the population. So we can concentrate particularly in this group of patients our attention for the therapeutic point of view and to pay particular attention to them.
Of course, when I’m saying that these patients are at risk of dying, their risk of dying means that I would say their survival rate after five years is still over 60%. So not so bad corresponding to other leukaemias, to other haematological malignancies. But, however, this is a higher risk with respect to those who can be really not fearing so much the consequences of their disease.
Is there anything else you would like to add?
No, I think that just the usefulness of collecting data is very important because, as I said before, what we are observing in clinical studies and which are sometimes the basis for the so-called recommendations that are international, like the NCCN or the European Leukaemia Network recommendation, but may also be local, should be based on real life data and not only on clinical studies because this sometimes is excluding some patients so it doesn’t give a perfect picture of what is going on for our patients.