Improving outcomes with brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma.
Bibliographic record
Abstract
7534 Background: ECHELON-1 is a phase 3 study of BV plus doxorubicin, vinblastine, and dacarbazine (A+AVD) vs ABVD as frontline therapy in untreated advanced HL (NCT01712490). G-CSF primary prophylaxis (G-PP) was administered at the investigators’ discretion, and during the study was formally recommended by an independent data monitoring committee (IDMC) for patients (pts) receiving A+AVD. For pts receiving A+AVD, G-PP was associated with fewer infections and ≥ Grade 3 AEs, including neutropenia (70% without vs 29% with G-PP) and febrile neutropenia (21% vs 11%). Methods: Exploratory analyses assessing outcomes and exposure in pts who received G-PP on the A+AVD arm compared with those who did not were conducted. G-PP was defined as use of G-CSF by Day 5 of treatment (tx); non-G-PP pts included pts who received G-CSF secondary prophylaxis. Results: 1334 pts with advanced HL were randomized 1:1 to receive A+AVD or ABVD. In 662 pts treated with A+AVD, G-PP was given to 42 of 499 pts who started tx prior to, and 41 of 163 pts who started tx after the IDMC recommendation. Across tx arms, baseline characteristics were similar between the subgroups. G-PP, compared with no G-PP, was associated with a lower rate of BV dose delays (35% vs 49%) and dose reductions (20% vs 26%), and decreased hospitalization rates (pts with at least 1 hospitalization 29% vs 38%). Of the 7 neutropenia-associated deaths during A+AVD tx, none occurred in pts who received G-CSF prior to the onset of neutropenia. A+AVD with G-PP was associated with a decreased risk of a modified progression free survival event (mPFS; Connors, 2018) by 25% compared to A+AVD without G-PP and by 42% compared to ABVD. Clinical trial information: NCT01712490. Conclusions: Concomitant administration of G-PP with A+AVD in pts with advanced HL reduced AEs and frequency of tx delays. Though the sample size is small, G-PP with A+AVD may be associated with improved efficacy and a decrease in early, neutropenia-associated deaths; a prospective clinical trial to further assess the safety and efficacy in pts receiving G-PP with A+AVD is planned. A+AVD ABVD With G-PP Without G-PP N 83 581 670 2-year mPFS % 84.6 81.7 77.2 95% CI 73.7, 91.3 78.1, 84.8 73.7, 80.4 Hazard ratio vs ABVD 0.58 0.79 - 95% CI 0.31, 1.07 0.62, 1.02
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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 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".