EHA 2016
Results from SCHOLAR-1 trial for DLBCL patients
Prof Christian Gisselbrecht - LYSARC, Pierre-Bénite, France
At the present time we have all the discussion on new drugs, new developments of technology and, of course, all the studies are trying to start with refractory patients but we, I don’t know its name, you have different ways of looking at that and it’s not very well standardised. So we decided to put a different group of patients coming from two large randomised studies in relapsed diffuse large B-cell lymphoma, one from myself, the CORAL study, the other one from the Canadian LY12 study and other data from the MD Anderson and Mayo Clinic. We made a selection of these patients on the basis of refractoriness, so they had to receive chemotherapy so it’s the definition of chemotherapy, they have to be stable or progressive after either the first line treatment, the second line treatment and, for diffuse large B-cell lymphoma, if they respond they have to be submitted to autologous stem cell transplantation as a consolidation. So we included patients relapsing after autologous stem cell transplantation. So that was a very large cohort, we started with 861 patients and we selected 635 patients and they had to receive, of course, some intent to treat chemotherapy and we have access on an individual database for these patients but mainly we look at the IPI, the clinical characteristic and the duration of response for all these patients. So quite a lot of big data we see for this population, hopefully not so frequent.
What kinds of outcomes can you report from the data?
Today I will report on the result of this study and we look, of course, at different parameters which were the presentation between these three groups. All of them were disseminated stages, 90%. If you take the IPI to define diffuse large B-cell lymphoma, 50 of them were with a poor IPI, they were mostly young patients with a median age of 55 and with a good performance status because they were eligible for chemotherapy. We looked first at the response rates for these patients with different types of treatment, whether we call… I mean that was mainly chemotherapy, standardised chemotherapy and the response rate for this group of patients was 26% with only 8% in complete remission. So that means that with chemotherapy you cannot achieve a good effect for the treatment of this progressive disease. In terms of repartition you have half of these patients after second line of treatment, 29 after the first line of treatment and 17 refractory post-autologous stem cell transplantation. There was no difference between these three types of progressive refractory patients and no difference according to this main prognostic factor. So that was a little bit of a surprise, we expected to have, for example, more response in the first line refractory patients and so on and so forth.
With that we looked at the survival, of course, and pretty much survival, overall survival, with a median of 6.6 months. It ranged from 5 months to 7 months or 8 months which means that we have a homogeneous group of patients where we know where they are and that can be the backbone for a definition of refractory patients instead of saying, well, they are refractory but they are still sensitive and so on and so forth at that time, we really have a good definition and we hope that it will be used in the future when we will have to build some comparators for new technology such as the CAR T-cells which are maybe the most promising new technology for diffuse large B-cell lymphoma. In the same way then for rituximab there was a definition of refractory rituximab for low grade lymphoma, follicular lymphoma, at the present time we have a strong definition for refractory patients for diffuse large B-cell lymphoma.
We were surprised also to see that 20% of these patients, or 17%, were alive at three years and so we are to look at that more carefully. I know from my data from the CORAL study that only the patients submitted to allotransplant could be a long survivor for that. So maybe that will be the place of new technology when you know that allotransplant is not so easy to do and you have quite a lot of toxicity.
