The addition of rituximab to a short intensive chemotherapy regimen improved event-free survival in adult patients with Burkitt lymphoma or leukemia, a study published in the journal The Lancet has shown.1
Burkitt lymphoma is a type of high-grade non-Hodgkin lymphoma that develops from B cells and is one of the fastest growing lymphomas. The standard of care for adults with Burkitt lymphoma or leukemia is short intensive chemotherapy, but single-arm studies have suggested that the addition of rituximab to these regimens may improve patient outcomes. Therefore, researchers sought to evaluate the addition of rituximab in a randomized, controlled trial.
For the open-label, phase 3 trial, researchers enrolled 260 adult patients with untreated HIV-negative Burkitt lymphoma or leukemia. Patients were stratified into 2 groups based on the absence (group B) or presence (group C) of bone marrow or central nervous system involvement. Patients were further stratified in group C with respect to age (< 40 years, 40 to 60 years, and > 60 years) and central nervous system involvement.
Participants were randomly assigned in each group to receive either rituximab 375 mg/m2 intravenously on days 1 and 6 during the first 2 courses of chemotherapy for a total of 4 infusions plus chemotherapy or chemotherapy alone.
Results showed that with a median follow-up of 38 months, patients who received rituximab achieved a 3-year event-free survival of 75% (95% CI, 66 – 82) compared with 62% (95% CI, 53 – 70) for the chemotherapy alone group (HR, 0.59; 95% CI, 0.38 – 0.94; P = .025).
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In terms of safety, adverse events did not significantly differ between the 2 treatment arms. The most common adverse events were infectious and hematologic in nature.
- Ribrag V, Koscielny S, Bosq J, et al. Rituximab and dose-dense chemotherapy for adults with Burkitt’s lymphoma: a randomised, controlled, open-label, phase 3 trial [published online ahead of print April 11, 2016]. Lancet. doi: 10.1016/S0140-6736(15)01317-3.