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Patient-reported outcomes (PROs) in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) treated with dostarlimab (D) plus carboplatin/paclitaxel (CP) compared with CP in the ENGOT-EN6/GOG3031/RUBY trial.

2023· article· en· W4387962267 on OpenAlexaff
Mansoor Raza Mirza, Mark S. Shahin, Matthew A. Powell, Caroline Lundgren, Vladyslav Sukhin, Bhavana Pothuri, Lucy Gilbert, Sarah Gill, Graziana Ronzino, Nicole Nevadunsky, Stefan Kommoss, Lyndsay Willmott, Ingrid Boere, Cara Mathews, Joseph Buscema, Michael Teneriello, Oren Meyers, Jamie Garside, Robert L. Coleman, Brian M. Slomovitz

Bibliographic record

VenueJCO Oncology Practice · 2023
Typearticle
Languageen
FieldMedicine
TopicEndometrial and Cervical Cancer Treatments
Canadian institutionsMcGill University Health Centre
Fundersnot available
KeywordsMedicinePlaceboEndometrial cancerInternal medicinePopulationCarboplatinQuality of life (healthcare)UrologyProgression-free survivalPaclitaxelClinical endpointGastroenterologyRandomized controlled trialOncologyCancerChemotherapyCisplatin

Abstract

fetched live from OpenAlex

332 Background: In RUBY (NCT03981796), a phase 3, global, randomized, double-blind trial, D+CP demonstrated significant and clinically meaningful improvement in PFS vs placebo + CP (P+CP) in pA/rEC. Methods: 494 pts with pA/rEC were randomized 1:1 to D+CP or P+CP Q3W for 6 cycles (C), followed by D or placebo monotherapy Q6W for ≤2 y. EORTC QLQ-C30 and EN24 (prespecified secondary endpoints) were administered on day 1 of each C, at end of treatment (EOT), and at safety and survival follow-ups. Change (chg) from baseline (BL) to C7 (end of chemotherapy) and C13 (1 y) was calculated in the overall and mismatch repair–deficient (dMMR)/microsatellite instability–high (MSI-H) populations. Least-squares means (LSM) were generated using mixed models for repeated measures, adjusting for correlations across multiple assessments within a pt and controlling for BL global, pain, fatigue, and physical function (PF) scores. Results: In the overall population, PROs were similar with D+CP and P+CP through C7, and no differences between arms across the 3-y period were reported; mean chg from BL to EOT showed numerical improvement with D+CP in back/pelvic pain and deterioration with P+CP in global QOL/GHS, social function (SF), body image, and chg in taste. In the dMMR/MSI-H population, at C7, nominally significant improvements in QOL, PF, role function (RF), pain, and back/pelvic pain were seen with D+CP vs P+CP (Table). Conclusions: Dostarlimab+CP significantly improved PFS and maintained HRQOL in dMMR/MSI-H and overall populations, further supporting its use as a standard of care in pA/rEC. Clinical trial information: NCT03981796 .[Table: see text]

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.002
Threshold uncertainty score0.013

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.002
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0010.002
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0020.000

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.

Opus teacher head0.053
GPT teacher head0.365
Teacher spread0.312 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations1
Published2023
Admission routes1
Has abstractyes

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