Patient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in participants with high-risk locally advanced cervical cancer
Bibliographic record
Abstract
Objective In ENGOT-cx11/GOG-3047/KEYNOTE-A18 (NCT04221945), pembrolizumab (vs placebo) + concurrent chemoradiotherapy (CCRT) followed by pembrolizumab (vs placebo) significantly improved progression-free survival and overall survival in participants with newly diagnosed, high-risk locally advanced cervical cancer (LACC). We report patient-reported outcomes (PROs) from the study. Methods Participants (≥18 years) with high-risk LACC (FIGO 2014 stage IB2–IIB with node-positive disease or stage III–IVA) were randomized 1:1 to 5 cycles of pembrolizumab 200 mg or placebo Q3W plus CCRT, followed by 15 cycles of pembrolizumab 400 mg or placebo Q6W. CCRT was 5 cycles (optional 6th dose) of cisplatin 40 mg/m 2 Q1W plus external beam radiotherapy followed by brachytherapy. Secondary PRO endpoints included EORTC QLQ-C30 GHS/QoL and physical functioning subscales and EORTC QLQ-CX24 symptom experience scale; EQ-5D-5L visual analogue scale (VAS) was an exploratory endpoint. No alpha was assigned to the PRO analyses. Results 1008 (95.1 %) of 1060 randomized participants were included in the PRO full analysis set population. No meaningful between-group differences were observed for any of the prespecified PRO instruments. Between-group differences (95 % CIs) in least-squares mean score changes from baseline to week 36 (primary time point) were 0.57 (−2.34 to 3.49) for QLQ-C30 GHS/QoL, 0.64 (−1.54 to 2.82) for QLQ-C30 physical functioning, 0.54 (−1.02 to 2.09) for QLQ-CX24 symptom experience, and −0.55 (−2.97 to 1.86) for EQ-5D-5L VAS. Empirical mean score changes over time and the proportions of participants whose scores improved, remained stable, or deteriorated over time were similar between treatment arms. Conclusions Pembrolizumab+CCRT did not negatively impact participants' health-related quality of life.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".