A Phase 3, Randomized, Placebo-Controlled Trial of Filgrastim in Patients (Pts) with Hematologic Malignancies (HM) Treated with a Myeloablative Conditioning Regimen and Allogenic Bone Marrow Transplantation (allo BMT).
Notice bibliographique
Résumé
Abstract Background. Recombinant methionyl granulocyte colony-stimulating factor (methuG-CSF; Filgrastim) is commonly used to reduce the duration of neutropenia that follows allo BMT performed after high-dose chemo-/radiotherapy (HDT) in pts with HM. Recently, a retrospective chart review suggested that leukemic pts treated with G-CSF after allo BMT had faster neutrophil recovery, but slower platelet engraftment, increased risk of graft vs host disease (GvHD), and reduced survival relative to pts who did not receive G-CSF (Ringdén et al, 2004). The present double-blind, randomized, placebo-controlled, multicenter phase 3 study was designed to evaluate the effects of Filgrastim treatment on neutrophil recovery. Pts were to be followed for 2 years. Methods. Eligible pts were aged 12–55 and scheduled for allo BMT from a sibling donor preceded by high-dose chemotherapy +/− total body irradiation for treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL), high-risk non-Hodgkin’s lymphoma (NHL), acute myeloid leukemia (AML), or chronic myeloid leukemia (CML). Pts were randomized to receive either Filgrastim (5μg/kg/day) or placebo from transplant until recovery of an absolute neutrophil count (ANC) of ≥0.5x109/L or for a maximum of 42 days. Randomization was stratified by age (<18 and ≥18 years) and remission status (1st complete remission/subsequent remissions) within each center. The primary endpoint was the time to ANC of ≥0.5x109/L. Assuming a standard deviation of 3.8 days, the study was powered to have a probability of at least 80% of detecting a difference of at least 3.6 days between the groups for the endpoint of time to ANC ≥0.5x109/L using a two-tailed significance of 5%. Results. The first pt was enrolled in 1993; however, the planned sample size of 100 pts (50 per arm) was not reached due to slow enrollment and the study was terminated in 1996. A total of 66 pts were enrolled; of these, 51 were analysed (25 Filgrastim, 26 placebo). Filgrastim-treated pts achieved an ANC of ≥0.5x109/L at a median (quartiles) time of 15 (13, 16) days compared with 19 (17, 22) days for placebo; ANC ≥1.0x109/L was reached by 16 (15, 17) and 22 (21, 28) days, respectively. Median (quartiles) time to discharge from hospital was 30 (26, 43) days for Filgrastim vs 36 (28, 42) days for placebo. The number of pts with platelet count ≥25x109/L within 56 days was 16 for Filgrastim vs 23 for placebo, and 12 vs 18, respectively, for platelet count ≥50x109/L within 56 days. The incidence, maximum severity and number of days to onset of acute GvHD were similar across the groups. No difference in adverse events was reported; 4 Filgrastim pts died (0 of disease progression) and 8 placebo pts died (3 of disease progression). Conclusion. The results of this phase 3, double-blind, placebo-controlled, randomized trial in pts with HM receiving allo BMT may suggest that Filgrastim treatment enhances neutrophil engraftment with no negative impact on platelet recovery or GvHD.
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 | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,002 | 0,004 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
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 ».