END OF TREATMENT <scp>PET‐CT</scp> PREDICTS PROGRESSION‐FREE SURVIVAL IN <scp>DLBCL</scp> AFTER FIRST‐LINE TREATMENT: RESULTS FROM THE PHASE III <scp>GOYA</scp> STUDY
Bibliographic record
Abstract
The study was designed to assess whether GA101-miniCHOP could increase the CRR compared to historical data.The null hypothesis (p0) has been set equal 0.60 on the basis of what reported by Peyrade et al (Lancet Oncol, 2011), and the alternative hypothesis (p1) was set at 0.75, with a type I and II error of 10% and 90%.A total of 71 patients were required with at least 48 CR to conclude for the efficacy of treatment.An interim analysis was planned after 34 patients, and at least 22 CR were required to proceed with enrollment.Analysis was by intention to treat.We here report the results of the stage 1.Results: Thirty-four patients were enrolled from August 2015 to June 2016 by 15 Italian centers.One patient was subsequently excluded due to violation of inclusion criteria.Median age was 82 years (68-89), 18 were males, and IPI was 3-5 in 21 cases.Overall, 228 cycles were delivered, and 27 patients completed all 6 planned courses.Treatment was interrupted in 4 patients due to adverse events (AE) and in 2 due to lack of response.Final response was reported as CR in 14 patients (42%) and partial in 8 (24%); 10 patients had stable or progressive disease (30%), and 1 patient (3%) was not assessed.AEs were reported in 28 cases: hematological grade 3-4 AEs included neutropenia (13 cases, 39%) and thrombocytopenia (1 case, 3%); grade 3-4 non-hematological AEs occurring in more than one case included skeletal muscle (2 cases, 6%) and metabolic disorders (3 cases, 9%).With the observed CR rate, the study has failed the planned interim analysis, and enrollment has been interrupted.Conclusions: GA101-miniCHOP is active and well tolerated for the treatment of elderly unfit patients affected by DLBCL.Based on initial study assumptions and on the observed CRR, at the interim analysis, we will not be able to demonstrate the initial study hypothesis that GA101-miniCHOP could improve results of historical data obtained with R-miniCHOP in this setting of 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".