18th Congress of EHA

Rituximab for B-cell lymphoma and EHA overview

Prof Ulrich Jäger - EHA President and Vienna Medical University, Austria

Dr Jäger, thank you very much for making us feel so welcome at Stockholm this year. As President of the European Haematology Association what has most excited you at this meeting? What have been the main highlights?

The main highlight at this meeting, I think, is educationals, I have to say that. I think our main strength is still educationals and that may even be at the level of the American Society meeting. We have a wonderful selection of speakers and chairs and I think people appreciate that very much. That also relates to our CME activities and to curriculum which we have developed. On the research level we have been struggling during recent years with the best abstracts because people tended to send their best work to ASH or to ASCO or to Lugarno which is, this year, very close. However, I have to say that this year we were very pleased to see that there are outstanding abstracts and what we were also lacking was clinical trials and we are very pleased to say that there are clinical trials in the best abstract session. The exciting developments mainly relate to new drugs, I would say antibodies, IMiDs, new inhibitors, kinase inhibitors, and those are well represented in the best abstracts in various diseases.

Now you yourself have presented details of the NHL13 clinical trial which was in aggressive B-cell lymphoma. Can you describe that study and outline what your main findings were?

The major question here is when you have a patient who has an aggressive lymphoma, diffuse large B-cell lymphoma in remission, can you prolong that remission or prevent relapse by applying a maintenance treatment? There was one previous study in patients over 60 which was the ECOG-4494 study which showed that this treatment has no effect, so observation versus maintenance was no difference. That’s why we started several years ago, I think the first patient went on trial in 2004, we started a clinical trial exploring that randomised. We tried to have it as close to clinical practice as possible so it was R-CHOP six, R-CHOP eight times, depending on the clinical stage and on the preference of the investigators, and that was followed by a two-year period of rituximab maintenance. The primary endpoint was event free survival and the p-value on that event free survival is 0.06 which means the primary endpoint was not met and you could say the study is negative. However, when we looked into the planned subgroup analysis we saw that there are populations which clearly profit and those populations are the low risk, IPI low, patients and they are mainly younger patients which is interesting. Also what we saw as a significant finding is that applying rituximab maintenance prevented relapse by 45% which is a significant number but in statistical terms it was not different. So what the significance of this trial is that we’ve shown that there is an effect, the effect is strong in subgroups and that we should explore this treatment further in these subgroups. We could clearly define some subgroups where there is no use and that’s in line with the previous study which was done in the US.

So the results of this study, although, as you say, some people might think it was a negative outcome, does it not reinforce the argument that such strategies can be applied as personalised medicine to some groups of patients?

I think that’s perfectly true, however, I would stress that we still need another randomised trial in order to show that because now if you pick a sub-population and if we clearly show in an intelligent way in this sub-population that there is a significant effect then, of course, I would recommend to use it. That would mean that only, let’s say, 25% of patients who have diffuse large B-cell lymphomas, a well-defined subgroup, will have a benefit from it. That’s in line with individualised treatment but we need more evidence. I think as researchers we would have to say that.

And finally you handed over presidency of the EHA on Saturday, what would you like to see over the next twelve months before EHA meets again in Milan, both in terms of the organisation itself and in terms of new clinical developments?

I think the organisation itself is very healthy, we are a European organisation and that, of course, enables us to act on the European level to help the European haematologists. What we are currently doing is we are advocating for more research money, we are trying to establish a curriculum all over Europe, the same curriculum for young doctors. We are also involved in advocacy with patient organisations which I think is also very important. We have in many instances the same questions and we would like to develop that further but the main points are certainly research and education. And that will be developed through our programmes which are, I think, excellent.

And in terms of clinical advances?

Clinical advances I think of as, let’s say, a political organisation. Of course we would like to see that investigator-driven academic trials are made easier in Europe because that’s one of the problems we have and that’s why we also participate in actions in order to facilitate these trials. The Clinical Trials Directive is in revision and I think that’s one of the tasks that an organisation like ours can do – facilitate for our haematologists’ clinical trials.

Is there any one blood disorder over another that is really in need of more research, do you think, at the moment?

Maybe if I can make two comments. What I would like to stress is that haematology is not only malignant hematologic diseases, there are a lot of non-malignant, non-oncological diseases which we sometimes tend to forget, like anaemias, like inborn errors, where we have a lot of things to research. Paediatric haematology - we’ve seen interesting abstracts at this meeting looking at granulocytopenia. That’s one thing and of course the other thing that will probably happen is that through the fragmentation of the subgroups we will have a lot of orphan diseases like T-cell lymphomas, for instance, where we don’t have a decent second line treatment. Those would be the areas where we have to develop. And elderly patients, so next year the theme of the year is haematology in elderly patients and that, of course, will also be one of our targets.

Dr Jäger thank you very much indeed.