Adding Rituximab to Dose-Dense Chemotherapy May Be of Benefit in Burkitt Lymphoma
In a French phase III trial reported in The Lancet, Ribrag et al showed that adding rituximab (Rituxan) to dose-dense chemotherapy improved event-free survival among adults with Burkitt lymphoma.
Study Details
In the open-label trial, 260 patients were randomized between October 2004 and September 2010 to receive chemotherapy (lymphoma Malin B, LMB) with (n = 130) or without (n = 130) rituximab. Patients were stratified according to absence (60 in rituximab group, 64 in control group) or presence (70 in rituximab group, 66 in control group) of bone marrow or central nervous system (CNS) involvement.
Chemotherapy included induction with COPADM (fractionated cyclophosphamide, vincristine, prednisone, doxorubicin, high-dose methotrexate) in all patients and consolidation with CYM (cytarabine, methotrexate, and steroids) in patients without and CYVE (cytarabine and etoposide) in those with marrow or CNS involvement. Rituximab was given at 375 mg/m2 on day 1 and day 6 during the two courses of COPADM. The primary endpoint was 3-year event-free survival.
Event-Free Survival
Median follow-up was 38 months. Three-year event-free survival was 75% (95% confidence interval [CI] = 66%–82%) in the rituximab group vs 62% (95% CI = 53%–70%) in the control group (hazard ratio [HR] = 0.59, P = .025). Three-year overall survival was 83% vs 70% (HR = 0.51, P = .012).
Toxicity
Adverse events did not differ between the two groups. The most common adverse events were infections (grade 3 or 4 in 17% vs 15% of treatment cycles) and hematologic adverse events (mean duration of grade 4 neutropenia of 3.31 vs 3.38 days per cycle).
The investigators concluded: “Addition of rituximab to a short intensive chemotherapy programme improves [event-free survival] in adults with Burkitt’s leukaemia or lymphoma.”
The study was funded by Gustave Roussy Cancer Campus, Roche, Chugai, and Sanofi.
Vincent Ribrag, MD, of Gustave Roussy, Université Paris Saclay, is the corresponding author of The Lancet article.
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