EHA 2016 | The multi-cohort SCHOLAR-1 study of refractory aggressive DLBCL
Christian Gisselbrecht, MD from Saint-Louis Hospital, Paris, France discusses the multi-cohort SCHOLAR-1 study of refractory aggressive diffuse large B-cell lymphoma (DLBCL), the most common non-Hodgkin lymphoma subtype. The idea behind the trial was to understand how to define refractory patients. Dr Gisselbrecht describes the method of the study and the results. To generate a new protocol to compare new technology, a stable definition was required. SCHOLAR-1 included data from two Phase III studies, namely the LYSARC-CORAL and the Canadian Cancer Trials Group study (CCTG)-LY.12 alongside two observational cohorts from the MD Anderson Cancer Center and the Mayo Clinic/University of Iowa Specialized Program of Research Excellence.
The team looked into the survival of the clinical characteristics of the patients not achieving response after chemotherapy, maintaining a stable disease, or patients with a progressive disease. Dr Gisselbrecht explains that there are three situations that arise at this stage. First, the disease is refractory after the first-line. Second, the patient gets remission, relapses, and returns to chemotherapy where the disease remains stable, but progresses further. Patients with DLBCL relapsing who are chemosensitive should then be referred for stem cell transplantation – some of whom are cured and some of whom are not. Through the scope of patients through protocol, Dr Gisselbrecht describes that only 597 (corrected from 635, based on original abstract) of the 861 patients were eligible according to the criteria set in place. Of the remaining, they were divided into primary refractory, secondary refractory, and 17% relapsed after transplantation.
The age range of this population of patients was much younger, given they were eligible for transplant in the first place. Analyzed on the basis of the type of chemotherapy treatment received and the consequent patient response rates, Dr Gisselbrecht states that conventional chemotherapy was not successful in the population of patients with refractory DLBCL, with a response rate of 20-30%, with 8% in complete remission and a median overall survival of 6.6 months, thereby suggesting that a new treatment needs to be developed to fit this unmet need. He further describes that 17% of the patients experienced a longer survival after 3-years, with 90% of the patients dying after 6 months. Chimeric antigen receptor (CAR) T-cells, which show an increased response rate and a prolonged duration, now provide hope.
Recorded at the European Hematology Association (EHA) 2016 Annual Congress in Copenhagen, Denmark.
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