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Article: Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children

TitleRituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children
Authors
Issue Date2020
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2020, v. 382, p. 2207-2219 How to Cite?
AbstractBACKGROUND: 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.)
Persistent Identifierhttp://hdl.handle.net/10722/290626
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorMinard-Colin, V-
dc.contributor.authorAupérin, A-
dc.contributor.authorPillon, M-
dc.contributor.authorBurke, GAA-
dc.contributor.authorBarkauskas, DA-
dc.contributor.authorWheatley, K-
dc.contributor.authorDelgado, RF-
dc.contributor.authorAlexander, S-
dc.contributor.authorUyttebroeck, A-
dc.contributor.authorBollard, CM-
dc.contributor.authorZsiros, J-
dc.contributor.authorCsoka, M-
dc.contributor.authorKazanowska, B-
dc.contributor.authorChiang, AK-
dc.contributor.authorMiles, RR-
dc.contributor.authorWotherspoon, A-
dc.contributor.authorAdamson, PC-
dc.contributor.authorVassal, G-
dc.contributor.authorPatte, C-
dc.contributor.authorGross, TG-
dc.date.accessioned2020-11-02T05:44:52Z-
dc.date.available2020-11-02T05:44:52Z-
dc.date.issued2020-
dc.identifier.citationNew England Journal of Medicine, 2020, v. 382, p. 2207-2219-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/290626-
dc.description.abstractBACKGROUND: 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.)-
dc.languageeng-
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/-
dc.relation.ispartofNew England Journal of Medicine-
dc.rightsFrom [Publication Title, Author(s), Title of Article, Volume No., Page No. Copyright © (notice year) Massachusetts Medical Society. Reprinted with permission.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.titleRituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children-
dc.typeArticle-
dc.identifier.emailChiang, AK: chiangak@hku.hk-
dc.identifier.authorityChiang, AK=rp00403-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1056/NEJMoa1915315-
dc.identifier.pmid32492302-
dc.identifier.pmcidPMC7720281-
dc.identifier.scopuseid_2-s2.0-85085997893-
dc.identifier.hkuros317751-
dc.identifier.volume382-
dc.identifier.spage2207-
dc.identifier.epage2219-
dc.identifier.isiWOS:000538140600014-
dc.publisher.placeUnited States-
dc.identifier.issnl0028-4793-

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