35th ESMO Congress, 8–12 October 2010, Milan

Interview with Professor Simon van Belle (University Hospital Ghent, Ghent, Belgium)

CHOICE study and the importance of quality assurance in oncology

First of all, the drug we have been studying, not especially the drug but at least the use of this drug in solid tumours where at the moment that the patient was put on Aranesp he has been followed for at least four weeks and most of the time for twelve weeks. And what we have been looking at is first of all the effectiveness of the drug and we’ve seen that in at least 60% of the patients we had a good effectiveness.

How do you measure that?

That means that you have within four weeks an increase of haemoglobin of 1g/dL or at the end, in some countries you can continue until two or three months and then you need 2g/dL. Now another thing that is very important that we wanted to know is at what moment the drug was started, or if you put it another way, at what moment patients with anaemia were treated for their anaemia. What we have been seeing is that first of all physicians wait until the moment that the Hb decreases under the level of 10g/dL and that means that in most of the cases the patients will have symptoms. Now what we see also is that it is started in between 9.5 - 9.8, something like that, and that we see little or not that high a number of patients where they wait until you have real symptomatic anaemia.

One of the important things is that we wanted to know if this is really according to the recent rules, you can call it, that have been published in Europe and the States where first of all you don’t start your treatment too soon, that’s what we have seen, that’s certainly the case, even if you have to ask yourself if you don’t start it too late because the moment that patient has symptoms you’d better try to avoid  that.

Another important thing is that until five years ago ESA was continued until something like 13-14g/dL. Now we know that if you go above 12 that the risk of thromboembolic events is really increasing. And that’s one of the warnings that’s on the leaflet of the ESAs and we have seen in the CHOICE survey that almost all treatments were stopped before 12 or as soon as they see that they were above 12. So we have less than 10% of the patients at just a little bit above 12. So we can say that in about 90% of the cases that the use of Aranesp was according to the prescription rules. That’s very important because this is one of the surveys that’s looking at good clinical practice but especially at quality assurance in oncology and I think we need more of these trials. We have been doing such a trial, for example, in anti-emetics where we know that if you look at the published studies that about 50% of the use of anti-emetics is not correct. Some of these studies were in Italy, for example, and not correct means that there was an under-treatment of emesis, that’s the big problem - half of them are waiting until patients were really complaining it’s too much. We have done such a survey for the NK1 receptor antagonist aprepitant in highly emetogenic and moderate emetogenic, and what we have seen in Belgium in about 160 patients, we have seen that the use of anti-emetic guidelines is correcting about 90% and then you have 10% a little bit of overtreatment. So we have a switch from undertreatment within five years to a little bit of overtreatment. For the patients I think it’s better to have a little bit of overtreatment than undertreatment.

So that’s very satisfying. The guidelines are not just being ignored.

That’s very satisfying, yes, and I think that’s a tremendous change. If you look ten years ago when guidelines were something that were for, I should call it, dummies in oncology – if they didn’t know what to do they followed the guidelines and all the clever people thought that they had their own guidelines. Now we see that most of the, certainly, medical oncologists are aware that the guidelines are not just there for bothering their life but for helping them to give the best quality to the patients.

Simon, thank you very much indeed and good luck with this work, it’s very important and I’m sure it’s not the most rewarding kind of work but quality assurance is absolutely for the patient the most important part of oncology. Thank you very much.