In the last couple of years we have incorporated a frailty scale, the one that is recommended by the International Myeloma Group which was published a couple of years ago by Palumbo and colleagues. I think it’s a very useful tool because in patients not candidates to a bone marrow transplantation, I mean elderly patients, it’s generally a population that is not included in clinical trials so a lot of toxicities are found when we treat these patients, mostly with triplet. So it’s a very useful tool and we have recommended, I’m part of the Grupo Argentino de Mieloma Múltiple in Argentina, a multiple myeloma group, and we recommend it. It’s easy, it’s available on the web so we use it and it helps to decide which treatment to use. Frail patients use generally doublets or less intense treatments, otherwise not frail patients, or what we call the go-go patients, we use full dose and treatment.
Are the data from RWE studies in RRMM comparable to those of your patients in the daily clinical practice?
That’s a very interesting question because studies that show real world evidence sometimes do not reflect what randomised controlled trials conclude. So there is a gap in the outcomes, not only responses but survival as well, in terms of these different studies. So for us it’s very important, the result from real world evidence studies. In fact, one of our limitations in Latin America is that, unfortunately, we do not have any published data, local published data, in the international literature so we are starting to work on national and Latin American registries in order to understand our reality.
So real world evidence is an important tool, it is well-known that around half or more of the patients in the common clinical practice should fail a selection in randomised controlled trials and that’s very important to have data on that. So, yes, we value the publishing of real world evidence.
What medical conduct do you follow with MM patients in biochemical relapse?
Another very good question. Our conduct has changed due to the COVID-19 pandemic. The COVID pandemic arrived in our country mid-March and since that time the Argentinian Group of Myeloma has recommended not to treat any biochemical relapse. So right now we are not treating any biochemical relapse but as the pandemic has become timely larger I think we are going to recommend what we recommended before the pandemic which was to treat patients in biochemical relapse if they have a very aggressive disease diagnosis or, for example, if they have what is called an evolving pattern of the monoclonal output chain or if the patient has high risk cytogenetics.
But, let me mention one important thing that in our country only one centre performs cell sorting in multiple myeloma. So we have difficulties in patients where we perform FISH analysis and we don’t know if they are really negative. So a large amount of false negatives we have in our country.
What are your experiences regarding multiple myeloma treatment in Argentina?
In my centre which is a university hospital that works with mostly private insurances we are fortunate for them because we always have access to the novel medications, I mean access to the IMiDs, lenalidomide, pomalidomide, to proteasome inhibitors such as bortezomib, ixazomib and carfilzomib as well, and more recently to monoclonal antibodies – daratumumab and elotuzumab. So we can have nearly all the treatment options that, for example, our colleagues in Spain have. So, for me, there is not a limitation or a barrier to treat my patients.
But, I must say, that in the public health system sometimes the access to these novel agents, which are most treatments are very expensive, it’s limited.
Are there any real-world studies regarding multiple myeloma treatment from ASH 2020 that have caught your eye?
Yes, I can tell you two papers that caught my attention. For example, one of them is real world evidence that Leleu and colleagues are going to present from Europe and it’s about the use of carfilzomib combinations in patients exposed and/or refractory to lenalidomide. They found that in more than 500 patients that real world evidence showed lower PFS than randomised controlled trials; it shows lower responses as well. They suggest that the combination of carfilzomib plus dexamethasone should be a backbone for lenalidomide refractory patients. So that abstract caught my attention.
The other abstract that I found very interesting is the one that Ludwig and colleagues are going to present about the effectiveness and safety of ixazomib-based therapies in relapsed refractory multiple myeloma but treated outside clinical trials. They conclude in more than 300 patients, I believe, that they found a similar PFS and overall response rate as was published in the randomised controlled trial, the TOURMALINE-1. So it’s much more like our experience with this model in the Argentinian Multiple Myeloma Group that ixazomib is an effective drug and without any toxicities in contrast to carfilzomib that we can never reproduce our results as shown in randomised controlled trials such as ASPIRE or any others, it’s much more toxic.
Is there anything you’d like to add?
Latin America is a very heterogeneous region with different healthcare systems and different modalities between countries. We need local data to understand our epidemiology and how our patients are treated. So it’s very important to join us together and make registries and so on.