Lenalidomide maintenance after stem-cell transplantation for multiple myeloma.

Détails

ID Serval
serval:BIB_A51FB5B0019E
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Lenalidomide maintenance after stem-cell transplantation for multiple myeloma.
Périodique
New England Journal of Medicine
Auteur(s)
Attal M., Lauwers-Cances V., Marit G., Caillot D., Moreau P., Facon T., Stoppa A.M., Hulin C., Benboubker L., Garderet L., Decaux O., Leyvraz S., Vekemans M.C., Voillat L., Michallet M., Pegourie B., Dumontet C., Roussel M., Leleu X., Mathiot C., Payen C., Avet-Loiseau H., Harousseau J.L.
Collaborateur(s)
IFM Investigators
Contributeur(s)
Rajkumar V., Spencer A., Chevret S., Nobili-Escriva C., Petillon MO., Olivier P., Cristini C., Llau ME., Agape P., Ali-Ammar N., Assouline D., Audhuy B., Banos A., Bareau B., Belhadj K., Berthou C., Boue F., Boullanger N., Bouscary D., Burkhard R., Cailleres S., Casassus P., Chateleix C., Coiffier B., De Bock R., Demuynck H., Dib M., Dorvaux V., Driessen C., Fitoussi O., Fontan J., Fruchart C., Fuzibet JG., Gratwohl A., Grosbois B., Heizmann M., Jardel H., Jaubert J., Ketterer N., Kolb B., Lacotte Thierry L., Lamy T., Lenain P., Lepeu G., Levaltier X., Lioure B., Maigre M., Maisonneuve H., Matthes T., Meuleman N., Mineur P., Moreau P., Orsini-Piocelle , Pabst T., Pierre P., Rauch D., Ravoet C., De Revel T., Rio B., Rodon P., Salle V., Sebahoun G., Sebban C., Sutton L., Thyss A., Van den Neste E., Vandevelde A., Wetterwald M., Zachee P., Zucca E., Zunic P.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Statut éditorial
Publié
Date de publication
2012
Volume
366
Numéro
19
Pages
1782-1791
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
BACKGROUND: High-dose chemotherapy with autologous stem-cell transplantation is a standard treatment for young patients with multiple myeloma. Residual disease is almost always present after transplantation and is responsible for relapse. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide maintenance therapy after transplantation.
METHODS: We randomly assigned 614 patients younger than 65 years of age who had nonprogressive disease after first-line transplantation to maintenance treatment with either lenalidomide (10 mg per day for the first 3 months, increased to 15 mg if tolerated) or placebo until relapse. The primary end point was progression-free survival.
RESULTS: Lenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001). This benefit was observed across all patient subgroups, including those based on the β(2)-microglobulin level, cytogenetic profile, and response after transplantation. With a median follow-up period of 45 months, more than 70% of patients in both groups were alive at 4 years. The rates of grade 3 or 4 peripheral neuropathy were similar in the two groups. The incidence of second primary cancers was 3.1 per 100 patient-years in the lenalidomide group versus 1.2 per 100 patient-years in the placebo group (P=0.002). Median event-free survival (with events that included second primary cancers) was significantly improved with lenalidomide (40 months, vs. 23 months with placebo; P<0.001).
CONCLUSIONS: Lenalidomide maintenance after transplantation significantly prolonged progression-free and event-free survival among patients with multiple myeloma. Four years after randomization, overall survival was similar in the two study groups. (Funded by the Programme Hospitalier de Recherche Clinique and others; ClinicalTrials.gov number, NCT00430365.).
Mots-clé
Adult, Aged, Antineoplastic Agents/adverse effects, Antineoplastic Agents/therapeutic use, Disease-Free Survival, Double-Blind Method, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Maintenance Chemotherapy, Male, Middle Aged, Multiple Myeloma/drug therapy, Multiple Myeloma/mortality, Neoplasms, Second Primary/epidemiology, Stem Cell Transplantation, Thalidomide/adverse effects, Thalidomide/analogs & derivatives, Young Adult
Pubmed
Web of science
Création de la notice
28/05/2012 18:01
Dernière modification de la notice
03/03/2018 20:15
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