A Comparison of Elderly Patients with Aggressive Histology Lymphoma who Were Entered or Not Entered on to a Randomized Phase II Trial
Bibliographic record
Abstract
The purpose of this study was to compare the baseline patient characteristics, treatments and outcomes of elderly patients with aggressive histology lymphoma who were entered or not entered onto a randomized phase II trial. We previously conducted a randomized phase II trial in patients > or = 65 years of age who had advanced stage intermediate grade lymphoma. A registry of all patients meeting the inclusion criteria for that trial was maintained. Many patients were not entered on to the randomized trial because of the presence of at least one exclusion criterion, or because of patient or physician choice. We have compared the baseline characteristics, treatment, and survival of the randomized and non-randomized patients. Results show that 68 consecutive patients met inclusion criteria for the randomized trial. Thirty-eight patients satisfied all eligibility criteria, consented, and were randomized; 30 patients (44%) were not entered. In comparison with randomized patients, non-randomized patients were older (mean 75.9 vs. 72.4 years; P=0.013), had a poorer performance status (P=0.0006), were less likely to be given treatment with curative intent (60% vs. 100%; P<0.001), and were less likely to complete 6 cycles of such treatment (27% vs. 89%; P<0.001). With a median follow-up of > 7 years, actuarial 5-year survival is superior in randomized patients (44.3% vs. 10%; P<0.00001). In conclusion, a substantial number of patients did not enter our randomized trial phase II trial and had different characteristics, received different therapy and had inferior outcomes in comparison with randomized patients. Randomized trials of therapy for elderly lymphoma patients may include special selection criteria and results may not be generalizable to a substantial proportion of other older patients.
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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 | 0.006 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".