Rituximab maintenance therapy following autologous stem-cell transplantation (ASCT) is associated with prolonged event-free survival, progression-free survival, and overall survival in younger patients with mantle cell lymphoma (MCL), according to a recent phase III trial.
MCL is typically incurable, and patients with the disease have relapses despite high rates of complete responses after initial immunochemotherapy followed by ASCT.
Steven Le Gouill, MD, PhD, Nantes Medical University (France), and colleagues evaluated 299 patients with MCL who had been younger than age 66 years at diagnosis. Patients (n = 120) were randomly assigned to either receive rituximab maintenance (375 mg) therapy per square meter of body-surface area every 2 months for 3 years following ASCT, or to undergo observation after transplantation (n = 120). The researchers noted that 59 patients did not undergo randomization. Median follow-up from randomization after transplantation lasted 50.2 months
The primary outcome was event-free survival following transplantation in patients who had undergone randomization. An event was defined as disease progression, relapse, death, allergy to rituximab, or severe infection.
Results of the study were initially presented at the 58th American Society of Hematology Annual Meeting (December 3, 2016; San Diego, CA). Updated data were recently published in the New England Journal of Medicine (September 2017;377:1250-1260).
A total of 257 patients had undergone transplantation. Results indicated that the overall response rate following four courses of immunochemotherapy induction [rituximab, dexamethasone, cytarabine, and a platinum derivative (R-DHAP)] was 89%. The reported complete response rate was 77%.
At 4 years after randomization, the rates of event-free survival (79% vs 61%), progression-free (83% vs 64%), and overall survival (89% vs. 80%) were higher in the rituximab group vs the observation group. Cox regression unadjusted analysis showed that the rate of overall survival at 4 years was higher in patients on rituximab maintenance therapy than in those who had undergone observation.
“Rituximab maintenance therapy after transplantation prolonged event-free survival, progression-free survival, and overall survival among patients with MCL who were younger than 66 years of age at diagnosis,” the researchers concluded. —Christina Vogt