Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children
| Autor: | Minard-Colin, Véronique, Aupérin, Anne, Pillon, Marta, Burke, G A Amos, Barkauskas, Donald A, Wheatley, Keith, Delgado, Rafael F, Alexander, Sarah, Uyttebroeck, Anne, Bollard, Catherine M, Zsiros, József, Csoka, Monika, Kazanowska, Bernarda, Chiang, Alan K, Miles, Rodney R, Wotherspoon, Andrew, Adamson, Peter C, Vassal, Gilles, Patte, Catherine, Gross, Thomas G, European Intergroup for Childhood Non-Hodgkin Lymphoma, Children’s Oncology Group, Brichard, Bénédicte |
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| Přispěvatelé: | Clinical sciences, Growth and Development, Pediatrics, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Oncology
Male Pediatrics medicine.medical_treatment Lymphoma B-Cell/drug therapy Kaplan-Meier Estimate 030204 cardiovascular system & hematology Rituximab/administration & dosage Antineoplastic Agents Immunological 0302 clinical medicine Neutropenia/chemically induced immune system diseases hemic and lymphatic diseases Antineoplastic Combined Chemotherapy Protocols 030212 general & internal medicine Child Infusions Intravenous Medicine(all) General Medicine Progression-Free Survival Mature B-Cell Non-Hodgkin's Lymphoma Rituximab Female Lymph medicine.drug medicine.medical_specialty Lymphoma B-Cell Neutropenia Adolescent Child preschool Infections/etiology MEDLINE Infections Article 03 medical and health sciences Antineoplastic Agents Immunological/administration & dosage Internal medicine medicine Humans Progression-free survival Chemotherapy business.industry Antineoplastic Combined Chemotherapy Protocols/adverse effects Cancer medicine.disease Lymphoma Clinical trial business Follow-Up Studies |
| Zdroj: | The New England journal of medicine, Vol. 382, no. 23, p. 2207-2219 (2020) N Engl J Med |
| DOI: | 10.1056/nejmoa1915315 |
| Popis: | BACKGROUND: 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. METHODS: We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed. RESULTS: Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio 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 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion. CONCLUSIONS: Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival 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. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.). |
| Databáze: | OpenAIRE |
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