We did an international randomised phase III trial called HD16 for early stage Hodgkin’s lymphoma patients trying to figure out if we can identify patients that don’t need radiotherapy after the chemotherapy. We tried to do this by use of PET scan and assumed that the PET negative patients might be those who don’t need radiotherapy without losing tumour control. But unfortunately it turned out that this is not possible so we lose tumour control actually if we don’t apply radiotherapy to the PET negative patients. This was one of the main results from the trial and the other question was if the PET positive patients, despite getting radiotherapy, if this is truly a group that is on higher risk for relapse.
This was also confirmed, not as we initially thought but we just split up the patients into different groups by using the Deauville score which is a marker or a type for intensity of the PET scanning. It turned out that Deauville score 4 patients, so the most intense PET signal, that they are at much higher risk for relapse, nearly three-fold, compared to the other PET positive patients that are PET positive by Deauville score 3.
What endpoints were assessed and what were the conclusions of the study?
The endpoints were progression free survival was assessed, that was the main endpoint for both questions.
Actually one conclusion is that standard of care is still the combined modality treatment consisting of chemotherapy, two cycles ABVD, plus radiotherapy irrespective of PET results after chemotherapy. That’s the one main result. The other is that you could think of therapy intensification in those patients that are PET positive with Deauville score 4 after chemotherapy because they do worse and they might benefit from a more intense chemotherapy.
Is there anything you would like to add?
No, it was great to work with different colleagues from very different countries. There are more than 350 trial centres contributing to this trial from Germany, Austria, Switzerland, the Netherlands, and it was really good to do this trial because now we know a little bit more about how to treat patients better.
