Maintenance Therapy After ASCT in Younger Patients With Mantle Cell Lymphoma
In a French phase III trial, maintenance rituximab (Rituxan) improved event-free survival vs observation after autologous stem cell transplantation (ASCT) in younger patints with mantle cell lymphoma. These findings were reported by Le Gouill et al in The New England Journal of Medicine.
Study Details
In the trial, 299 patients aged < 66 years with untreated mantle cell lymphoma eligible for ASCT who had Ann Arbor stage II to IV disease were enrolled between September 2008 and August 2012. Of them, 279 received protocol treatment with 4 courses of induction with rituximab, dexamethasone, cytarabine, and a platinum derivative (R-DHAP); 257 underwent ASCT; and 240 were randomized to rituximab maintenance at 375 mg/m2 every 2 months for 3 years (n = 120) or observation (n = 120). The primary endpoint was event-free survival after ASCT.
Survival Outcomes
Among all patients, the overall response rate was 89%, and the complete response rate was 77% after four courses of induction therapy. Median follow-up was 50.2 months after ASCT.
Median event-free, progression-free, and overall survival were not reached in either group. Event-free survival at 4 years was 79% in the rituximab group vs 61% in the observation group (hazard ratio [HR] = 0.46, P = .001). At 4 years, progression-free survival was 83% vs 64% (HR = 0.40, P < .001), and overall survival was 89% vs 80% (HR = 0.50, P = .04).
Adverse Events
Serious infection after ASCT occurred in four patients in each group. The most common grade 3 or 4 toxicity was neutropenia. Death due to second cancers occurred in three patients in the rituximab group and in one patient in the observation group. No late effects of rituximab were observed in either group.
The investigators concluded: “Rituximab maintenance therapy after transplantation prolonged event-free survival, progression-free survival, and overall survival among patients with mantle-cell lymphoma who were younger than 66 years of age at diagnosis.”
The study was funded by Roche and Amgen.
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