Rituximab Maintenance Compared With Observation After Brief First-Line R-FND Chemoimmunotherapy With Rituximab Consolidation in Patients Age Older Than 60 Years With Advanced Follicular Lymphoma: A Phase III Randomized Study by the Fondazione Italiana Linfomi

Abstract

A brief R-FND induction plus rituximab consolidation achieved excellent results with high CR and PFS rates, supporting the feasibility of this regimen in patients older than 60 years. A short rituximab maintenance did not achieve a statistically significant PFS improvement over observation.

Rituximab Maintenance Strategy in Advanced Follicular Lymphoma: Facts and Controversies

“…Primary endpoint of the study was 2-year PFS reaching 81% in rituximab group versus 69% in maintenance group. However, this diff erence was not statistically signifi cant (p=0.226) 39 . Th ere may have been several reasons, e.g., short follow up, limited rituximab exposure, small sample underpowered to detect diff erence and use of non-standard immunochemotherapy regimen in the fi rst line setting.…”

“…One of the main criticisms of rituximab maintenance therapy in high tumor burden FL is the fact that improvement in PFS has not yet translated in OS benefi t by clinical trials and meta-analyses 31,[35][36][37][38][39]43 . Several factors aff ecting OS in FL should be taken into account.…”

Rituximab maintenance therapy in diffuse large B-cell lymphoma: is XY the most important variable?

“…5 Early T precursor ALL is characterized by lack of CD1a and CD8, weak CD5 expression, at least one myeloid/stem cell marker, a specific transcriptional profile and the possible involvement of several critical genes. 6 No new treatment approaches are currently available for this subtype, and thus SCT in first complete remission is the preferred option.…”

“…2 The use of rituximab in FL subsequently expanded as results of randomized trials emerged showing remission prolongation with maintenance rituximab after single agent rituximab and combined rituximab-chemotherapy and then similar results in mantle cell lymphoma. [3][4][5][6][7] A theme began to develop: rituximab maintenance was most useful in B-cell NHL subtypes in which the majority of patients do not have durable remissions. However, in diffuse large B-cell lymphoma (DLBCL), the most common NHL, in which the majority of patients who achieve a complete remission after rituximab-chemotherapy are cured, maintenance rituximab therapy has not been felt to be efficacious.…”

Nature and importance of follicular lymphoma precursors

“…For the majority of patients with disseminated disease at diagnosis, rituximab is currently being explored as a promising alternative due to its low toxicity profile and its proven efficacy in symptomatic indolent FL. 78 Intermediate data analysis from an ongoing phase III study in advanced stage FL patients with low tumor burden reported that induction/maintenance with rituximab as single-agent delayed the need for chemotherapy, and decreased the risk of worsening disease compared to the WW arm of the trial. [79][80][81] Time-tonext-therapy and progression-free survival (PFS) were significantly increased (PFS at 3 years was of 33% in the WW arm vs. 81% in the rituximab arm), and the median time to initiation of chemotherapy was not reached at four years in patients on rituximab.…”