KEYNOTE-629: Health-related quality of life (HRQoL) with pembrolizumab (pembro) in patients (pts) with locally advanced (LA) or recurrent or metastatic (R/M) cutaneous squamous cell carcinoma (cSCC).
Bibliographic record
Abstract
9546 Background: KEYNOTE-629 is a single-arm phase 2 study of pembro for cSCC. At second interim analysis (IA), pembro had robust and durable antitumor activity and manageable safety in LA and R/M cohorts. At first IA, pembro maintained HRQoL in the R/M cohort; LA was not analyzed because of ongoing accrual. HRQoL of pts with LA or R/M cSCC at second IA (database cutoff July 29, 2020; additional 15-mo follow-up since IA1 for the R/M cohort) is shown. Methods: Pts with LA or R/M cSCC received pembro 200 mg IV Q3W for ≤35 cycles. HRQoL was a prespecified exploratory end point assessed using EORTC QLQ-30 and EuroQol EQ-5D-5L instruments administered at baseline, wk 3, and wk 6; then Q6W through y 1; then Q9W until treatment end/discontinuation; and at the 30-day safety follow-up. HRQoL was analyzed in pts who received ≥1 pembro dose and completed baseline and ≥1 postbaseline HRQoL assessments. Mean change from baseline in EORTC QLQ-C30 global health status (GHS)/quality of life (QoL), physical functioning (PF), and EQ-5D-5L visual analog scale (VAS) scores were evaluated at wk 12 to ensure adequate completion rate and through last pt visit at wk 75 for EORTC QLQ-C30 GHS/QoL and PF scores. HRQoL was categorized as improved or deteriorated based on ≥10-point change in EORTC QLQ-C30 scores (considered clinically meaningful). Results: The HRQoL analysis population for LA had 47 pts for EORTC QLQ-C30 and EQ-5D-5L; the R/M cohort had 99 pts for EORTC QLQ-C30 and 100 for EQ-5D-5L. At wk 12, compliance rates were >75% for LA and >80% for R/M cohorts for EORTC QLQ-C30 and EQ-5D-5L. Mean change from baseline to wk 12 was minimal for EORTC QLQ-C30 GHS/QoL, PF, and EQ-5D-5L VAS scores for both cohorts (Table). Mean change from baseline in EORTC QLQ-C30 GHS/QoL and PF scores remained stable over 48 wk in the LA cohort (75-wk data unavailable) and over 75 wk in the R/M cohort. Most pts had improved or stable EORTC QLQ-C30 GHS/QoL and PF scores relative to baseline during follow-up. Conclusions: HRQoL was generally maintained with pembro in LA and R/M cSCC cohorts and was not negatively impacted by tumor progression or AEs. Clinical trial information: NCT03284424. [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 | 0.001 | 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 | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".