Title :

Lenalidomide Maintenance Compared With Placebo in Responding Elderly Patients With Diffuse Large B-Cell Lymphoma Treated With First-Line Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone

Author(s) :

Thieblemont, Catherine [Auteur]
Tilly, Herve [Auteur]
Gomes Da Silva, Maria [Auteur]
Casasnovas, Rene-Olivier [Auteur]
Fruchart, Christophe [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Haioun, Corinne [Auteur]
Lazarovici, Julien [Auteur]
Grosicka, Anida [Auteur]
Perrot, Aurore [Auteur]
Trotman, Judith [Auteur]
Sebban, Catherine [Auteur]
Caballero, Dolores [Auteur]
Greil, Richard [Auteur]
Van Eygen, Koen [Auteur]
Cohen Amos, M [Auteur]
Gonzalez, Hugo [Auteur]
Bouabdallah, Reda [Auteur]
Oberic, Lucie [Auteur]
Corront, Bernadette [Auteur]
Choufi, Bachra [Auteur]
Lopez-Guillermo, Armando [Auteur]
Catalano, John [Auteur]
Van Hoof, Achiel [Auteur]
Briere, Josette [Auteur]
Cabecadas, Jose [Auteur]
Salles, Gilles [Auteur]
Gaulard, Philippe [Auteur]
Bosly, Andre [Auteur]
Coiffier, Bertrand [Auteur]

Journal title :

Journal of clinical oncology

Abbreviated title :

J. Clin. Oncol.

Volume number :

35

Pages :

2473

Publication date :

2017

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Lenalidomide, an immunomodulatory ...
Show more >Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Lenalidomide, an immunomodulatory agent, has shown activity in DLBCL. This randomized phase III trial compared lenalidomide as maintenance therapy with placebo in elderly patients with DLBCL who achieved a complete response (CR) or partial response (PR) to R-CHOP induction. Methods Patients with previously untreated DLBCL or other aggressive B-cell lymphoma were 60 to 80 years old, had CR or PR after six or eight cycles of R-CHOP, and were randomly assigned to lenalidomide maintenance 25 mg/d or placebo for 21 days of every 28-day cycle for 24 months. The primary end point was progression-free survival (PFS). Results A total of 650 patients were randomly assigned. At the time of the primary analysis (December 2015), with a median follow-up of 39 months from random assignment, median PFS was not reached for lenalidomide maintenance versus 58.9 months for placebo (hazard ratio, 0.708; 95% CI, 0.537 to 0.933; P = .01). The result was consistent among analyzed subgroups (eg, male v female, age-adjusted International Prognostic Index 0 or 1 v 2 or 3, age younger than 70 v ≥ 70 years), response (PR v CR) after R-CHOP, and positron emission tomography status at assignment (negative v positive). With longer median follow-up of 52 months (October 2016), overall survival was similar between arms (hazard ratio, 1.218; 95% CI, 0.861 to 1.721; P = .26). Most common grade 3 or 4 adverse events associated with lenalidomide versus placebo maintenance were neutropenia (56% v 22%) and cutaneous reactions (5% v 1%), respectively. Conclusion Lenalidomide maintenance for 24 months after obtaining a CR or PR to R-CHOP significantly prolonged PFS in elderly patients with DLBCL.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Research team(s) :

Innovation/évaluation des médicaments injectables

Submission date :

2019-02-26T17:07:10Z