Patients with mantle-cell lymphoma (MCL) are commonly treated with a combination regimen comprising rituximab and high-dose cytarabine, followed by autologous stem-cell transplantation (ASCT). In a study led by Steven Le Gouill, post-transplantation maintenance therapy with rituximab has been shown to extend event-free survival (EFS).

In this trial, 299 patients younger than 66 years of age at diagnosis received induction therapy with rituximab, dexamethasone, high-dose cytarabine and a platinum derivative (R-DHAP regimen). The overall and complete response rates after induction were 94% and 41%, respectively.

Subsequently, 257 patients underwent ASCT, and 240 of them were randomly assigned (1:1 ratio) to either rituximab maintenance therapy or observation only. The scheduled 3-year rituximab treatment course was completed by 83 patients. Median follow-up durations were 54.4 months from inclusion, and 50.2 months from randomization.

In the randomized population, median EFS, progression-free survival (PFS) and overall survival (OS) durations were not reached in either group. The 4-year EFS, PFS and OS rates were higher in the rituximab group compared with the observation group (79%, 83% and 89%, versus 61%, 64% and 80%). Neutropenia, the most common grade 3–4 toxicity, was more frequent with rituximab than with observation (41.1%, 15.7% and 12.1% with <6 months, 6–12 months or 12–36 months of maintenance therapy, respectively, versus 26.3%, 0.9% and 2.9%). Indeed, rituximab was discontinued in 9 patients owing to neutropenia and in 16 patients owing to disease progression.

These results show that maintenance therapy with rituximab after R-DHAP and ASCT improves the outcomes of patients with MCL. Whether this maintenance regimen would benefit patients who receive other pre-ASCT combinations of rituximab remains to be determined.