Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma.

Détails

ID Serval
serval:BIB_3F1CAC361B26
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma.
Périodique
Journal of Clinical Oncology
Auteur(s)
Morschhauser F., Radford J., Van Hoof A., Vitolo U., Soubeyran P., Tilly H., Huijgens P.C., Kolstad A., d'Amore F., Gonzalez Diaz M., Petrini M., Sebban C., Zinzani P.L., van Oers M.H., van Putten W., Bischof-Delaloye A., Rohatiner A., Salles G., Kuhlmann J., Hagenbeek A.
ISSN
1527-7755[electronic]
Statut éditorial
Publié
Date de publication
2008
Peer-reviewed
Oui
Volume
26
Numéro
32
Pages
5156-5164
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Résumé
PURPOSE: We conducted an international, randomized, phase III trial to evaluate the efficacy and safety of consolidation with yttrium-90 ((90)Y)-ibritumomab tiuxetan in patients with advanced-stage follicular lymphoma in first remission. PATIENTS AND METHODS: Patients with CD20(+) stage III or IV follicular lymphoma, who achieved a complete response (CR)/unconfirmed CR (CRu) or partial response (PR) after first-line induction treatment, were randomly assigned to receive (90)Y-ibritumomab tiuxetan (rituximab 250 mg/m(2) on day -7 and day 0 followed on day 0 by (90)Y-ibritumomab tiuxetan 14.8 MBq/kg; maximum of 1,184 MBq) or no further treatment (control). The primary end point was progression-free survival (PFS), which was calculated from the time of random assignment. RESULTS: A total of 414 patients (consolidation, n = 208; control, n = 206) were enrolled at 77 centers. (90)Y-ibritumomab tiuxetan consolidation significantly prolonged median PFS (after a median observation time of 3.5 years) in all patients (36.5 v 13.3 months in control arm; hazard ratio [HR] = 0.465; P < .0001) and regardless of whether patients achieved PR (29.3 v 6.2 months in control arm; HR = 0.304; P < .0001) or CR/CRu (53.9 v 29.5 months in control arm; HR = 0.613; P = .0154) after induction treatment. Median PFS with consolidation was prolonged in all Follicular Lymphoma International Prognostic Index risk subgroups. After (90)Y-ibritumomab tiuxetan consolidation, 77% of patients in PR after induction converted to CR/CRu, resulting in a final CR rate of 87%. The most common toxicity with (90)Y-ibritumomab tiuxetan was hematologic, and grade 3 or 4 infections occurred in 8% of patients. CONCLUSION: Consolidation of first remission with (90)Y-ibritumomab tiuxetan in advanced-stage follicular lymphoma is highly effective with no unexpected toxicities, prolonging PFS by 2 years and resulting in high PR-to-CR conversion rates regardless of type of first-line induction treatment.
Mots-clé
Adult, Aged, Antibodies, Monoclonal/administration &amp, dosage, Antibodies, Monoclonal/adverse effects, Antigens, CD20/analysis, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Canada, Chemotherapy, Adjuvant, Disease-Free Survival, Europe, Female, Humans, Lymphoma, Follicular/drug therapy, Lymphoma, Follicular/immunology, Male, Middle Aged, Neoplasm Staging, Radioimmunotherapy, Radiotherapy, Adjuvant, Time Factors, Treatment Outcome
Pubmed
Web of science
Création de la notice
26/03/2009 16:34
Dernière modification de la notice
20/08/2019 13:36
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