Hello, my name is Andreas Engert. I am chairman of the German Hodgkin Study Group. I am a professor for hematology, oncology, and internal medicine here at the University Hospital in Cologne.
HD15 was a trial performed by our group. It included a total of five European countries and about 400 centers participating. These were small centers, larger centers, and university hospitals. Some of these centers just had one patient over the period of 5 years enrolled into this trial. So, it is a broad-based experience and that is how our first-line trials are being done. With a total of 2,200 patients in this three-arm trial, we tried to reduce the activity or side effects of treatment, that is, we compared 8 cycles of BEACOPP escalated to 6 cycles, and another variant was given at 2-week intervals. We showed that 6 cycles are better, are safer, and since have become our new standard of care. Much less side effects with 6 cycles, and we think that this is a good compromise between chemotherapy. There is very, very little radiotherapy given, only 11% of all patients received initial radiotherapy after chemo that was based on PET positive disease measuring more than 2.5 cm, and the outcome was that roughly 90% of patients were tumor-free and event-free at 5 years, and the overall survival at 5 years was 95%. So, we are well into the range of early stage Hodgkin’s. We are better than the results in early stage Hodgkin’s as a matter of fact. This treatment is safe if it is given according to our guidelines with additional growth factors to prevent severe leukopenia, additional antibiotics, also to prevent infectious diseases; and with that, I think it is a safe treatment that can be given elsewhere. We had a look at risk factors in a separate analysis over our trials and that showed that patients at risk for toxicity with BEACOPP escalated are those who are frail and those who are older than 50 years old, and those who are between 40 and 50 are in the mixed risk group. Patients younger than 40 are at the very low-risk group. So, if you treat patients with BEACOPP escalated for the first time, it might be good idea to have the patient in the hospital for this first cycle in order to be double sure that that the patient receives this treatment and understands how he has to behave, but that is what we do in our trials, particularly in high-risk patients. But with all that, I think you can cure more patients long-term, and it is a safe and validated treatment with as I said with more than 4,000 patients treated.