END OF TREATMENT <scp>PET‐CT</scp> PREDICTS PROGRESSION‐FREE SURVIVAL IN <scp>DLBCL</scp> AFTER FIRST‐LINE TREATMENT: RESULTS FROM THE PHASE III <scp>GOYA</scp> STUDY
Notice bibliographique
Résumé
Introduction: Establishing a new clinical trial end point, such as end of treatment (EOT) complete response assessed by 18F-FDG-PET (PET-CR), would allow early assessment of therapeutic efficacy. The prognostic value of EOT PET-CR for PFS and OS in DLBCL patients (pts) has been reported in several small studies, but requires confirmation in a large data set. We investigated the prognostic value of EOT PET for PFS in a large pt cohort treated with obinutuzumab (G) or rituximab (R) plus CHOP in the phase III GOYA study (NCT01287741; Vitolo 2016). Methods: Pts aged ≥18 years, with an ECOG performance status ≤2 and IPI score of ≥2, were enrolled, as well as low-risk pts with IPI scores of 1 (not due to age alone) or 0 (with bulky disease). Pts were randomised 1:1 to receive 8 × 21-day cycles of G (1000 mg IV on days [D] 1, 8, and 15, cycle [C] 1 and D1, C2-8) or R (375 mg/m2 IV on D1, C1-8) plus 6 or 8 cycles of CHOP (number of cycles preplanned for all pts at each site). Pts had an EOT PET-CT assessment 6-8 weeks after completion of treatment. PET-CT data were analysed according to Lugano criteria (based on Deauville 5-point scale; JCO 2014) modified in some patients by biopsy findings (m5PS; Table footnote), and revised International Working Group criteria (IWG2007; JCO 2007), at an independent central review facility by 3 radiologists plus a clinical reviewer. PET-CR status, according to each criteria, was compared with PFS. Results: Of 1418 enrolled pts, 1346 had a baseline PET scan, and 1334 had detectable lesions. Baseline clinical characteristics, eg, age, stage and IPI, were similar between treatment arms. There was no statistical difference in PFS between the treatment arms; thus, the entire cohort was analysed as a whole. Results at EOT by m5PS and IWG2007 criteria are presented (Table). After a median follow-up of 29 months, EOT PET-CR was highly predictive of PFS using m5PS or IWG2007; m5PS-based PET-CR yielded a lower hazard ratio (HR 0.27; 95% CI 0.20-0.38; p < 0.001) than IWG2007 (HR 0.34; 95% CI 0.25-0.46; p < 0.001; Figure). 2.5-yr PFS from EOT for m5PS response was 86.1% (95% CI 83.3-88.5) in pts achieving PET-CR vs 58.8% (95% CI 49.3-67.1) in pts who did not. Conclusions: This large prospective study confirms PET-CR as a strong predictor of PFS in DLBCL after 1 L immunochemotherapy, applying m5PS or IWG2007 criteria; m5PS provided a slight advantage. Meta analyses of these data with other prospective studies would be needed to further evaluate the potential surrogacy of PET-CR for PFS as a novel end point for future clinical trials. Keywords: diffuse large B-cell lymphoma (DLBCL); positron emission tomography (PET); prognostic indices
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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 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,001 |
| 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 découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».