Thank you very much for the introduction. Thank you for coming and thank you for your interest in our study. The purpose of our research – Hodgkin lymphoma is the most common malignancy amongst young adults so median age at onset of the disease is slightly above 30 years, 32 years. These are young people and treatment for patients with advanced stage disease, and half of the patients suffer from advanced stage disease, is very intense in order to cure them. Standard of care within our group is six, or it used to be eight, cycles of escalated BEACOPP which is a very intensive chemotherapy regimen. It’s very effective, it’s very well known to be very active, however toxicity of this regimen has been, and still is, a matter of concern. We know that individual patients might be cured with less burdensome treatment however we can’t predict who are the patients in whom we do not need that much treatment.

In this trial we investigated whether metabolic response, early interim metabolic response assessment by PET, so FDG-PET NCD, after two cycles of chemotherapy from a total of six or eight would allow us to select patients who could be treated with less cycles. They have a low risk because they are responding nicely to the treatment.

This is a prospective and international trial, it’s a phase III trial with five European countries contributing to this trial: Germany, Switzerland, Austria, the Czech Republic and parts of the Netherlands. We enrolled more than 2,000 patients in this trial, it’s a huge trial, between May 2008 and July 2014. They all were suffering from newly diagnosed advanced stage Hodgkin lymphoma. 1,005 patients have been PET negative so the others are PET positive. Today we are talking about those patients responding nicely to the first two cycles and then have a PET negative finding after two cycles. They were randomised then between eight cycles or four cycles only. So we reduced the treatment in these patients to four cycles only.

We aimed to show that these four cycles are non-inferior to six or eight cycles, to the more intensive treatment, that’s the aim of the study – to show non-inferiority. The result, very briefly summarised here, is what we found is that indeed only four cycles are non-inferior to eight or six cycles, which became standard of care during the study, in terms of five year progression free survival and this is true at a very high level. So the progression free survival at five years is 92.2% versus 90.8% and the difference is in favour of the less intensive treatment. So it was not even as good, it was even better. This is not significant but this was not the aim of the study, we just wanted to show that it is not inferior and it certainly is not inferior. We can safely conclude that four cycles are, in this patient cohort, as active as eight cycles.

However, we had much less toxicity and this then translated into an overall survival benefit. This was the secondary objective of our study, not the primary objective, but we found that more patients survived with the less intensive treatment and this again at an extremely high level, so it’s close to 98% at five years.

Indeed, we have seen only 0.7% dying from Hodgkin’s lymphoma. From 1,005 patients only 7 patients died from Hodgkin’s lymphoma so we can almost say we have eliminated Hodgkin’s lymphoma as a relevant cause of death in these young patients suffering from this cancer. We had fewer severe infections as you can see here. We had less organ toxicities just due to the reduction of treatment. We had very few patients with second neoplasia, including acute myeloid leukaemia, it’s just 2 out of more than 500 so 0.4%. And we have no treatment related mortality at all in this trial. Usually some of the patients, this is part of our treatment, have very severe side effects, they have infections and they can die from treatment, so the number is between 1-2% in all trials but in this trial not a single patient died when treated with four cycles only.

So we conclude that this is a very effective treatment, obviously you have heard the numbers. Almost all of the patients will be cured and it’s very safe, not a single patient died. It’s short and this might matter - standard of care took more than 24 weeks and other treatment regimens also take more than 24 weeks and we are down to 12 weeks. This might matter in this patient population. These are young patients who usually go to work, they start their career and if they are off their normal life for just three months or 6-8 months this might matter. We have seen improved quality of life in our cohort for the patients treated with less therapy.
We therefore strongly recommend the PET guided escalated BEACOPP strategy for patients with newly diagnosed advanced stage Hodgkin lymphoma.