S101: OMISSION OF RADIOTHERAPY IN PRIMARY MEDIASTINAL B-CELL LYMPHOMA PATIENTS FOLLOWING COMPLETE METABOLIC RESPONSE TO STANDARD IMMUNOCHEMOTHERAPY: RESULTS OF THE IELSG37 RANDOMISED TRIAL (NCT01599559)
Notice bibliographique
Résumé
Topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical Background: Primary mediastinal B-cell lymphoma (PMBCL) has a good prognosis if remission is rapidly achieved with dose-intensive immunochemotherapy. In these patients, mediastinal radiotherapy (RT) may consolidate responses; however, it increases the risk of second malignancies and coronary or valvular heart disease. Aims: The IELSG37 (NCT01599559) trial was planned with a non-inferiority design to test whether RT can be omitted in patients who achieve a complete metabolic response (CMR) after immunochemotherapy. Methods: Patients with newly diagnosed PMBCL were eligible. Initial rituximab and anthracycline-based regimen was chosen according to local practice. CMR was defined, upon central review of positron emission computed tomography (PET/CT) scans, as Deauville score 1 to 3, according to the Lugano classification. Responding patients were randomised to observation (OBS) or consolidation RT (30 Gy). Randomisation was stratified on gender, chemotherapy regimen, country, and PET/CT score. The primary endpoint was the progression-free survival (PFS) after randomisation. The sample size (540 patients to enrol, and 376 to randomise) was calculated assuming a 30-month PFS probability of 0.85 in both arms, with alpha at 0.05, 80% power and a hazard ratio (HR) of 1.77 as non-inferiority margin. Results: An interim analysis at median follow-up of 30 months showed a much lower number of observed events than expected, hence, the Independent Data Monitoring Committee (IDMC) of the trial recommended to complete the planned total accrual without increasing the study size or duration. The primary endpoint analysis was performed, according to the IDMC recommendation, with ≥80% of patients having a minimum follow-up of 30 months. 545 patients (209 men, 336 women) were enrolled. Induction immunochemotherapy was completed and response assessed in 530 patients, 268 of them (50.6%) achieved a CMR and were randomly allocated to OBS (n= 132) or RT (n=136). The median follow-up time of randomised patients was 59 months (interquartile range, 42-64). PFS at 30 months from randomisation was 98.5% (95%CI, 94.2-99.6) in the RT arm and 96.2% (95%CI, 91.1-98.4) in the OBS arm (Log-rank P=0.274). The estimated relative effect of radiotherapy vs observation in terms of hazard ratio (HR) was 0.47 (0.12-1.88) without adjustments and 0.68 (0.16-2.91) after stratification for the variables used for randomisation. At 30 months the absolute risk reduction from RT was 2.3% (-1.5 to 6.2) unadjusted, and 1.2% (-3.2 to 7.0) after adjustment. The number needed to treat is high (43 patients, unadjusted, and 126 after stratification). The 5-year overall survival was 99% in both arms. To date, 3 grade 3-4 cardiac events and 3 second cancers were recorded, all in patients randomised to radiation. Summary/Conclusion: This is the largest prospective study of PMBCL ever carried out. Although the event rate did not reach the expected level, and longer follow-up is required to properly evaluate late toxicities, our findings provide solid evidence to support the omission of RT in patients achieving a CMR after immunochemotherapy.Keywords: Extranodal lymphoma, Diffuse large B cell lymphoma, Radiotherapy, Positron emission tomography (PET)
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Comment cette classification a été obtenuedéplier
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 | 0,001 |
| 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 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 ».