Surrogate Endpoints for Overall Survival in Advanced Hepatocelluar Carcinoma in the Era of Immunotherapy: A Trial Level Meta-Analysis
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Notice bibliographique
Résumé
<p>Background: Systemic therapy containing immune checkpoint inhibitors (ICIs) has become the standard of care for patients with advanced hepatocellular carcinoma (HCC). A prior analysis from the pre-ICI era demonstrated a moderate correlation between progression-free survival (PFS) and overall survival (OS). We performed a literature-based meta-analysis to include randomized phase III trials (RCTs) of ICIs to evaluate surrogate endpoints for OS in advanced HCC. Methods: RCTs evaluating systemic therapies in advanced HCC published/presented between 2007 and 2024 were identified through a systemic literature search. Hazard ratios (HRs) for OS and PFS were extracted. The change in the overall response rates (ΔORR) was calculated as the difference between experimental and control arms. Pearson correlation and mixed-effects meta-regression analyses were performed. Strength of correlation was determined using the criteria from the Institute for Quality and Efficiency in Health Care (IQWIG). Surrogate threshold effect (STE) was determined for each comparison when possible. Subgroup analysis was performed. A p < 0.05 was considered to be statistically significant. Results: In total, 21 1st-line and 12 2nd-line RCTs were included. Of 1st-line RCTs, 48% evaluated ICIs either alone or in combination. There was a weak correlation between HR-PFS and HR-OS (n = 18, r = 0.64, 95% confidence interval (CI): 0.25–0.85, p = 0.004) and no correlation between ΔORR and HR-OS (n = 21, r = 0.42, 95% CI: −0.01 – 0.72, p = 0.06). The STE for HR-PFS was 0.68. Subgroup analyses revealed a moderate correlation between HR-PFS and HR-OS in 1st-line RCTs enrolling fewer patients with nonviral etiology (n = 9, r = 0.75, 95% CI: 0.17–0.94, p = 0.02). There was, however, a strong correlation between HR-PFS and HR-OS in 2nd-line RCTs (n = 10, r = 0.90, 95% CI: 0.61–0.98, p < 0.001). The STE for HR-PFS in 2nd-line RCTs was 0.87. Conclusion: The correlation between HR-PFS and HR-OS is weak in 1st-line RCTs in advanced HCC where OS remains the most appropriate endpoint. There is a strong association between HR-PFS and HR-OS for 2nd-line RCTs, suggesting that PFS is a suitable surrogate endpoint in that setting. </p>
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle