Adding Rituximab to LMB Chemo Extends OS, EFS in Young Patients With Mature B-Cell NHL
Phase 3 study findings show that adding rituximab to standard lymphomes malins B (LMB) chemotherapy extends event-free survival (EFS) and overall survival (OS) in young patients with high-grade, high-risk, mature B-cell non-Hodgkin’s lymphoma (NHL; N Engl J Med. 2020;382:2207-2219).
“Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin’s lymphoma are limited,” wrote Véronique Minard-Colin, MD, PhD, Department of Pediatric and Adolescent Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France, and colleagues.
To fill this gap in literature, Dr Minard-Colin et al carried out an open-label, international study of 328 patients (aged <18 years) with high-risk, mature B-cell non-Hodgkin’s lymphoma or acute leukemia; approximately 86% of the patients had Burkitt’s lymphoma. The goal was to compare the addition of 6 rituximab doses to standard lymphomes malins B (LMB) chemotherapy (n = 164) with standard LMB chemotherapy alone (n = 164).
The main end point of the study was EFS, and the researchers also evaluated [OS] and toxic effects.
The median follow-up time frame was 39.9 months, during which events were observed in 10 and 28 patients in the rituximab–chemotherapy and chemotherapy-alone arms, respectively.
The 3-year EFS was 93.9% (95% CI, 89.1-96.7) in the rituximab–chemotherapy arm and 82.3% (95% CI, 75.7-87.5) in the chemotherapy-alone group (hazard ratio [HR] for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15-0.66; 1-sided P = .00096).
Deaths were reported for 8 and 20 patients in each arm, respectively (hazard ratio, 0.36; 95% CI, 0.16-0.82).
Acute adverse events grade ≥4 were reported after pre-phase treatment in 33.3% of patients in the rituximab–chemotherapy group and 24.2% in the chemotherapy group (P = .07); these events were tied mostly to febrile neutropenia and infection.
Of note, almost twice as many patients in the rituximab–chemotherapy group had a low IgG level 1 year after being included in the study.
“Rituximab added to standard LMB chemotherapy markedly prolonged [EFS] and [OS] among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin’s lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection,” Dr Minard-Colin and co-investigators concluded.—Hina M. Porcelli