Results of Eastern Cooperative Oncology Group Protocol E4402 (RESORT): A Randomized Phase III Study Comparing Two Different Rituximab Dosing Strategies for Low Tumor Burden Follicular Lymphoma
Notice bibliographique
Résumé
Abstract Abstract LBA-6 Background: Optimal management for low tumor burden (LTB) follicular lymphoma (FL) in the rituximab (R) era is uncertain. Historical data with watch and wait (W & W) approaches are associated with an average of 3 years to initiation of chemotherapy. We hypothesized that rituximab could delay the need for chemotherapy and that maintenance rituximab (MR) would provide disease control superior to rituximab retreatment (RR) at progression. E4402 is a randomized phase III study comparing MR and RR for patients (pt) with previously untreated, LTB (by GELF criteria) FL. Methods: Pt received R 375 mg/m2 weekly × 4 and responders were randomized to MR (single dose R q 3 mo) or RR (R weekly × 4 at disease progression). Each strategy was continued until treatment failure. The primary endpoint, time to treatment failure (TTTF), was defined as progression within 6 mo of last R, no response to R retreatment, initiation of alternative therapy, or inability to complete protocol therapy. Pt were evaluated every 3 mo, with restaging CT scans every 6 mo. The study had 81% power to detect a TTTF hazard ratio of 0.64 favoring MR. Secondary endpoints included time to first cytotoxic therapy (TTCT), quality of life (QOL) and safety. The ECOG Data Monitoring Committee recommended release of study results at a planned interim analysis in September 2011. Results: From 11/03 to 9/08, 384 with FL were enrolled. Complete or partial response was achieved in 274 pt (71%), who were then randomized to MR (n=140) or RR (n=134). Demographic features were similar in the two arms: median age 59 yr; PS 0–1 in all pt; and FLIPI low-risk (14.9 vs. 16.4%), intermediate-risk (46.3 vs. 42.9%) and high-risk (38.8 vs. 40.7%) for MR vs. RR, respectively. The mean number of R doses/pt (including the 4 induction doses) was 15.8 (range 5– 31) for MR and 4.5 (range 4–16) for RR. With a median follow-up of 3.8 yrs, TTTF was and 3.9 yr for MR vs. 3.6 yr for RR (p=NS, Fig 1). A detailed analysis of treatment failure, by type, will be presented. At 3 yrs, 95% of MR vs. 86% of RR pt (p=.027, Fig 2) remained free of cytotoxic therapy. Grade 3–4 hematologic and non-hematologic toxicities occurred in < 5% of pt; 1 death on study occurred in each Arm. At 12 months post randomization, there was no discernible difference in health related QOL and anxiety between the two arms. Conclusions: In previously untreated, low tumor burden, follicular lymphoma, no difference in TTTF for MR vs. RR was observed. Notably, the time to initiation of cytotoxic therapy was delayed in both arms compared to historical W & W strategies with similarly defined LTB FL populations. MR was slightly superior to RR for TTCT but at a cost of 3x more R. MR did not improve QOL or anxiety. In summary, RR produces outcomes comparable to MR in this patient population. Disclosures: Kahl: Genentech: Consultancy; Roche: Consultancy. Williams:Genentech: Consultancy. Gascoyne:Roche: Consultancy; Genentech: Consultancy. Horning:Genentech: Employment, Equity Ownership.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,015 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,004 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,016 | 0,003 |
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 source (Gemma direct ou Codex distillé), 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 ».