Lenalidomide in combination with intravenous rituximab (revri) in relapsed/refractory primary cns lymphoma or primary intraocular lymphoma: a multicenter prospective " - Université de Lille Accéder directement au contenu
Article Dans Une Revue Annals of Oncology Année : 2019

Lenalidomide in combination with intravenous rituximab (revri) in relapsed/refractory primary cns lymphoma or primary intraocular lymphoma: a multicenter prospective "

Résumé

Primary central nervous system lymphomas (PCNSLs) are mainly diffuse large B-cell lymphomas (DLBCLs) of the non-germinal center B-cell (non-GCB) subtype. This study aimed to determine the efficacy of rituximab plus lenalidomide (R2) in DLBCL-PCNSL. Patients with refractory/relapsed (R/R) DLBCL-PCNSL or primary vitreoretinal lymphoma (PVRL) were included in this prospective phase II study. The induction treatment consisted of eight 28-day cycles of R2 (rituximab 375/m2 i.v. D1; lenalidomide 20 mg/day, D1-21 for cycle 1; and 25 mg/day, D1-21 for the subsequent cycles); in responding patients, the induction treatment was followed by a maintenance phase comprising 12 28-day cycles of lenalidomide alone (10 mg/day, D1-21). The primary end point was the overall response rate (ORR) at the end of induction (P0 = 10%; P1 = 30%). Fifty patients were included. Forty-five patients (PCNSL, N = 34; PVRL, N = 11) were assessable for response. The ORR at the end of induction was 35.6% (95% CI 21.9-51.2) in assessable patients and 32.0% (95% CI 21.9-51.2) in the intent-to-treat analysis, including 13 complete responses (CR)/unconfirmed CR (uCR; 29%) and 3 partial responses (PR; 7%). The best responses were 18 CR/uCR (40%) and 12 PR (27%) during the induction phase. The maintenance phase was started and completed by 18 and 5 patients, respectively. With a median follow-up of 19.2 months (range 1.5-31), the median progression-free survival (PFS) and overall survival (OS) were 7.8 months (95% CI 3.9-11.3) and 17.7 months (95% CI 12.9 to not reached), respectively. No unexpected toxicity was observed. The peripheral baseline CD4/CD8 ratio impacted PFS [median PFS = 9.5 months (95% CI, 8.1-14.8] for CD4/CD8 ≥ 1.6; median PFS = 2.8 months, [95% CI, 1.1-7.8) for CD4/CD8 < 1.6, P = 0.03). The R2 regimen showed significant activity in R/R PCNSL and PVRL patients. These results support assessments of the efficacy of R2 combined with methotrexate-based chemotherapy as a first-line treatment of PCNSL. NCT01956695.

Dates et versions

hal-03562849 , version 1 (09-02-2022)

Identifiants

Citer

Herve Ghesquieres, M. Chevrier, M. Laadhari, O. Chinot, Sylvain Choquet, et al.. Lenalidomide in combination with intravenous rituximab (revri) in relapsed/refractory primary cns lymphoma or primary intraocular lymphoma: a multicenter prospective ". Annals of Oncology, 2019, Annals of Oncology, 30 (4), pp.621-628. ⟨10.1093/annonc/mdz032⟩. ⟨hal-03562849⟩
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