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 - Université Paris Cité Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2017

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

1 Hôpital Saint-Louis
2 GPMCND - Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques
3 IPO Porto - Instituto Português de Oncologia do Porto / Portuguese Oncology Institute of Porto
4 CHU Dijon
5 LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
6 IHBN - Institut d'Hématologie de Basse-Normandie
7 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
8 CHU Henri Mondor [Créteil]
9 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
10 IGR - Institut Gustave Roussy
11 SUM - Medical University of Silesia
12 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
13 Concord Repatriation General Hospital
14 The University of Sydney
15 Centre Léon Bérard [Lyon]
16 UCBL - Université Claude Bernard Lyon 1
17 Hospital Universitario de Salamanca
18 PMU - Paracelsus Medizinische Privatuniversität = Paracelsus Medical University
19 Salzburg Cancer Research Institute
20 Algemeen Ziekenhuis Groeninge Hospital
21 Rabin Medical Center - Beilinson and Hasharon Hospitals [Petach-Tikva, Israel]
22 Centre Hospitalier René Dubos [Pontoise]
23 IPC - Institut Paoli-Calmettes
24 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
25 CHU Annecy
26 Centre Hospitalier Dr Duchenne (Boulogne-sur-mer)
27 CRESIB - Barcelona Centre for International Health Research, Hospital Clinic
28 Frankston Hospital
29 Monash University [Clayton]
30 Algemeen Ziekenhuis Sint Jan AV
31 SFR Necker - UMS 3633 / US24 - Structure Fédérative de Recherche Necker
32 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
33 IMRB - Institut Mondor de Recherche Biomédicale
34 Cliniques universitaires UCL de Mont-Godinne 5530 Yvoir
Bernadette Corront
  • Fonction : Auteur
Gilles Salles

Résumé

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.
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Dates et versions

hal-01609346 , version 1 (03-10-2017)

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Catherine Thieblemont, Hervé Tilly, Maria Gomes Da Silva, Rene-Olivier Casasnovas, Christophe Fruchart, et al.. 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. Journal of Clinical Oncology, 2017, 35 (22), pp.2473-2481. ⟨10.1200/JCO.2017.72.6984⟩. ⟨hal-01609346⟩
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