Accrual Of Patients With Relapsed and Refractory DLBCL Onto Clinical Trials
Bibliographic record
Abstract
Abstract Background New drug development in diffuse large B cell lymphoma (DLBCL) has become a very active area of research in the last several years with the advent of monoclonal antibodies and targeted therapies. We sought to determine the rate of accrual of patients with relapsed/refractory (R/R) diffuse large B cell lymphoma (DLBCL) onto early phase clinical trials, and hurdles to their enrolment by performing a retrospective analysis of all DLBCL cases diagnosed at our institution from 01/2006 to 03/2012. This time span represents an active time period for clinical trials in lymphoma at our institution. Methods DLBCL cases were identified through the hospital tumor registry. Patients were included in the analysis if they had any diagnosis ofDLBCL relapsed or refractory to standard therapy. Baseline demographics and disease characteristics, details of treatment, responses, relapse, evaluation for clinical trials and participation in clinical trials were determined by review of hospital charts. Only Phase I and II clinical trials were considered for this analysis. Results Of a total of 284 patients, 76 had relapsed/refractory disease, 10 of 25 had a successful autologous stem cell transplant (ASCT), and there is insufficient data on 1 patient. Of the remaining 65, 11 (17%) made it to trial. The median age was 65, 34 were male, median number of prior therapies was 2, 74% had at least one comorbidity and 46% had at least 2. Sixty-two percent of patients had de novo DLBCL, 18% transformed and 20% had a composite lymphoma including DLBCL. Reasons for failing to enroll on trial included prohibitive comorbidity (21%), rapid progression (15%), decision for palliation (15%), prior second malignancy (9%), thrombocytopenia (13%), CNS disease (9%), proximity to ASCT (2%), no protocol available(6%), palliative radiation (6%). Patients on trial tended to be younger (58.4 vs. 65.8 years), and to have a lower IPI (mean 3.1 vs 3.4). There was no difference in the number of prior of therapies (2.31 vs. 2.26) or number of comorbidities (2.18 vs 2.21). However, out of the 11 who made it to trial, 7 patients had failed ASCT (46.7% of patients who failed ASCT) vs. 4 (10%) who never had a transplant (p=0.005, Fisher’s exact test). Among the relapsed and refractory cases, 81% of cases were discussed at tumor board. Conclusions Although our study is small, we demonstrate that in an active research center, where a large number of R/R DLBCL patients are discussed at tumor board during which information about clinical trials is disseminated, a minority of patients with DLBCL not responding to standard therapy make it to trial.Patients having failed an ASCT are more successfully enrolled onto clinical trials. Interestingly, a similar accrual rate was seen in relapsed non-small cell lung cancer (Baggstrom,J Thor Oncol 2011) and similar barriers to enrolment were found for solid tumor patients (Lara, JCO 2001). Accrual of R/R DLBCL patients onto clinical trials is possible but challenging. A multi-institution analysis is underway. Disclosures: No relevant conflicts of interest to declare.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.018 | 0.047 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".