SCHOLAR-1
Needs reviewOutcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study
Phase observationalN = 636
- Population
- Patients with refractory diffuse large B-cell lymphoma: 636 of 861 patients met the refractory-disease inclusion criteria.
- Design
- International, multicohort retrospective study pooling patient-level data from two phase 3 trials (LYSA-CORAL and Canadian Cancer Trials Group LY.12) and two observational cohorts (MD Anderson Cancer Center; University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence). Refractory disease was defined as progressive or stable disease as best response during chemotherapy (more than 4 cycles of first-line or 2 cycles of later-line therapy) or relapse within 12 months of autologous stem-cell transplantation. Response and survival were estimated from the start of salvage therapy for refractory disease. Not a randomised or treatment-assigned study.
- Arms
- Refractory DLBCL cohort (pooled) (control, n = 636): Next line of salvage therapy as given in the pooled trial and observational cohorts
- People
- Crump M, senior author Gisselbrecht C
Show the numbers
| Endpoint | Analysis | Experimental | Refractory DLBCL cohort (pooled) | Effect |
|---|---|---|---|---|
| ORRPatients with refractory disease evaluable for response (523 of the 636 meeting the inclusion criteria)Objective response rate to the next line of therapy after refractoriness. | primaryCrump 2017 | — | 26% | Complete response rate 7%. Pooled retrospective data; not a trial result. |
| OSPatients with refractory disease evaluable for survival (603 of the 636 meeting the inclusion criteria)Overall survival from initiation of salvage therapy for refractory disease. | primaryCrump 2017 | — | median 6.3 months | Twenty percent (20%) of patients were alive at 2 years; stated in words in the abstract, so it is not stored as a landmark. |
| Endpoint | Analysis | Experimental | Refractory DLBCL cohort (pooled) | Effect |
|---|---|---|---|---|
| ORRPatients with refractory disease evaluable for response (523 of the 636 meeting the inclusion criteria)Objective response rate to the next line of therapy after refractoriness. | primaryCrump 2017 | — | 26% | Complete response rate 7%. Pooled retrospective data; not a trial result. |
| OSPatients with refractory disease evaluable for survival (603 of the 636 meeting the inclusion criteria)Overall survival from initiation of salvage therapy for refractory disease. | primaryCrump 2017 | — | median 6.3 months | Twenty percent (20%) of patients were alive at 2 years; stated in words in the abstract, so it is not stored as a landmark. |
- Refractory DLBCL cohort (pooled) (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Refractory DLBCL cohort (pooled) |
|---|---|
| 0 | 100.0% |
| 4 | 64.4% |
| 8 | 41.5% |
| 12 | 26.7% |
| 16 | 17.2% |