Health-related quality of life analysis of the LEAP-002 study of lenvatinib plus pembrolizumab versus lenvatinib as first-line treatment for advanced hepatocellular carcinoma
Bibliographic record
Abstract
BACKGROUND: Patients with advanced hepatocellular carcinoma (HCC) have a substantial symptom burden that affects their health-related quality of life (HRQoL). Assessing the impact of first-line regimens on HRQoL is essential to evaluate clinical benefit in addition to efficacy and safety in this setting. METHODS: LEAP-002 is a randomized phase III trial of lenvatinib plus pembrolizumab versus lenvatinib plus placebo as first-line treatment for participants with advanced HCC. Patient-reported outcomes (PROs) were prespecified exploratory endpoints assessed in all participants randomly assigned to treatment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 questionnaire (EORTC QLQ-C30), EORTC QLQ Hepatocellular Carcinoma 18-item module (EORTC QLQ-HCC18), and EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L) at baseline and throughout the trial. Median time to confirmed deterioration (TTD) in PROs was estimated using the Kaplan-Meier method. Least-squares mean change from baseline to week 27 (latest time point when completion and compliance rates were ≥60% and ≥80%, respectively) in PRO scores was assessed using a constrained longitudinal data analysis model. No formal hypotheses were tested. RESULTS: The PRO population comprised 779 participants (lenvatinib plus pembrolizumab, n = 390; lenvatinib plus placebo, n = 389). Completion rates for all PRO assessments were >94% at baseline and >63% at week 27. Median TTD for EORTC QLQ-C30 global health status/quality-of-life score was 11.5 months [95% confidence interval (CI) 5.6 months-not reached] in the lenvatinib plus pembrolizumab group and 4.3 months (95% CI 3.5-5.5 months) in the lenvatinib plus placebo group (hazard ratio 0.80, 95% CI 0.65-0.98). TTD and least-squares mean change from baseline to week 27 were similar between treatment groups for EORTC QLQ-C30 scales, EORTC QLQ-HCC18 scores, and the EQ-5D-5L visual analog scale. CONCLUSION: Adding pembrolizumab to lenvatinib, which is a current first-line option as a single agent, maintained HRQoL during the first-line treatment of participants with advanced HCC.
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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 | 0.010 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".