Patient-reported outcomes (PROs) in primary advanced or recurrent endometrial cancer (pA/rEC) for patients (pts) treated with dostarlimab plus carboplatin/paclitaxel (CP) as compared to CP in the ENGOT-EN6/GOG3031/RUBY trial.
Bibliographic record
Abstract
5504 Background: In RUBY, a phase 3, global, randomized, double-blind, placebo (PBO)-controlled trial, dostarlimab+carboplatin/paclitaxel demonstrated significant and clinically meaningful improvement in PFS compared with PBO+CP in pts with pA/rEC. PROs are reported here. Methods: 494 pts with pA/rEC were randomized 1:1 to dostarlimab (D)+CP or PBO+CP Q3W for 6 cycles followed by D or PBO monotherapy Q6W ≤3 yrs or to disease progression. EORTC QLQ-C30 and EN24 were prespecified secondary endpoints. PROs were administered on Day 1 of each treatment (tx) cycle (C), end of tx (EOT), and at safety and survival follow-ups and reported here for C7, the end of chemotherapy (chemo) and C13, and the end of 1 yr of study. Change (chg) from baseline (BL) to C7/C13 was calculated for all scales assessed. Mixed model for repeated measures analysis was conducted to generate least-squares means (LSM), adjusting for correlations across multiple time point assessments within a pt and controlling for the BL value for the global, pain, fatigue, and physical function (PF) scores. Results: PRO outcomes were similar for D+CP and PBO+CP through the chemo period (C7). The table shows selected scores at C7 and C13 for mean (SD) and chg from BL. Further, no differences across the 3 yr period between the 2 arms were reported; LSM (standard error) for global QoL was 0.5 (1.42; P=0.72), PF was −0.7 (1.39; P=0.63), fatigue was 0.2 (1.75; P=0.91) and pain was −1.0 (1.99; P=0.62). Mean chg from BL to EOT showed improvement in back/pelvic pain for D+CP and deterioration in global QoL/GHS, social functioning, body image, and chg in taste for pts on PBO+CP. Conclusions: Dostarlimab + CP significantly improved PFS while maintaining HRQoL, further supporting its use as a standard of care in pA/rEC. Clinical trial information: NCT03981796 . [Table: see text]
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| 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 | 0.001 | 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".