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Article: Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial

TitleDose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial
Authors
Issue Date2021
PublisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/
Citation
Journal of Clinical Oncology, 2021, v. 39 n. 33, p. 3716-3724 How to Cite?
AbstractPURPOSE A dose-adjusted etoposide, doxorubicin, and cyclophosphamide with vincristine and prednisone plus rituximab (DA-EPOCH-R) regimen has been shown to deliver excellent survival for adults with primary mediastinal large B-cell lymphoma (PMLBL) without the use of radiotherapy. No international prospective evaluation of this regimen has previously been reported in children and adolescents. PATIENTS AND METHODS We conducted an international single-arm phase II trial involving patients younger than age 18 years with PMLBL who were to receive six courses of DA-EPOCH-R. The primary end point was event-free survival (EFS). Overall survival and toxicity were also assessed. This trial was registered (ClinicalTrials.gov identifier: NCT01516567). RESULTS Analyses were based on 46 patients. The median age was 15.4 years (interquartile range: 14-16 years). The median follow-up was 59.0 months (interquartile range: 52.6-69.2 months). Fourteen events were observed (eight relapses or progressions (including three parenchymal CNS relapses), four residual lymphoma, and two second malignancies). The 4-year EFS was 69.6% (95% CI, 55.2 to 80.9), which did not differ from the rate observed historically (P = .59). Seven deaths occurred (six disease-related and one second malignancy). The overall survival was 84.8% (95% CI, 71.8 to 92.4). Twenty-two patients (48%) reached dose levels ≥ 4. Nonhematologic adverse events grade ≥ 3 or cardiac adverse events grade ≥ 2 occurred in 47 of 276 (17%) courses and 30 of 46 patients (65%). CONCLUSION DA-EPOCH-R did not improve the EFS compared with a historical control in this first prospective multisite international study of children and adolescents with PMLBL. Further studies are required to determine the optimum therapy for children and adolescents with this lymphoma. © 2021 by American Society of Clinical Oncology
Persistent Identifierhttp://hdl.handle.net/10722/309025
ISSN
2023 Impact Factor: 42.1
2023 SCImago Journal Rankings: 10.639
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorBurke, GAA-
dc.contributor.authorMinard-Collin, V-
dc.contributor.authorAuperin, A-
dc.contributor.authorAlexasnder, S-
dc.contributor.authorPillon, M-
dc.contributor.authorDelgado, R-
dc.contributor.authorZsiros, J-
dc.contributor.authorUyttebroeck, A-
dc.contributor.authorDartigues, P-
dc.contributor.authorMiles, RR-
dc.contributor.authorKazanowska, B-
dc.contributor.authorChiang, AK-
dc.contributor.authorHaouy, S-
dc.contributor.authorBollard, CM-
dc.contributor.authorCsoka, M-
dc.contributor.authorWheatley, K-
dc.contributor.authorBarkauskas, DA-
dc.contributor.authorAdamson, PC-
dc.contributor.authorVassal, G-
dc.contributor.authorPatte, C-
dc.contributor.authorGross, TG-
dc.date.accessioned2021-12-14T01:39:35Z-
dc.date.available2021-12-14T01:39:35Z-
dc.date.issued2021-
dc.identifier.citationJournal of Clinical Oncology, 2021, v. 39 n. 33, p. 3716-3724-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/309025-
dc.description.abstractPURPOSE A dose-adjusted etoposide, doxorubicin, and cyclophosphamide with vincristine and prednisone plus rituximab (DA-EPOCH-R) regimen has been shown to deliver excellent survival for adults with primary mediastinal large B-cell lymphoma (PMLBL) without the use of radiotherapy. No international prospective evaluation of this regimen has previously been reported in children and adolescents. PATIENTS AND METHODS We conducted an international single-arm phase II trial involving patients younger than age 18 years with PMLBL who were to receive six courses of DA-EPOCH-R. The primary end point was event-free survival (EFS). Overall survival and toxicity were also assessed. This trial was registered (ClinicalTrials.gov identifier: NCT01516567). RESULTS Analyses were based on 46 patients. The median age was 15.4 years (interquartile range: 14-16 years). The median follow-up was 59.0 months (interquartile range: 52.6-69.2 months). Fourteen events were observed (eight relapses or progressions (including three parenchymal CNS relapses), four residual lymphoma, and two second malignancies). The 4-year EFS was 69.6% (95% CI, 55.2 to 80.9), which did not differ from the rate observed historically (P = .59). Seven deaths occurred (six disease-related and one second malignancy). The overall survival was 84.8% (95% CI, 71.8 to 92.4). Twenty-two patients (48%) reached dose levels ≥ 4. Nonhematologic adverse events grade ≥ 3 or cardiac adverse events grade ≥ 2 occurred in 47 of 276 (17%) courses and 30 of 46 patients (65%). CONCLUSION DA-EPOCH-R did not improve the EFS compared with a historical control in this first prospective multisite international study of children and adolescents with PMLBL. Further studies are required to determine the optimum therapy for children and adolescents with this lymphoma. © 2021 by American Society of Clinical Oncology-
dc.languageeng-
dc.publisherAmerican Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/-
dc.relation.ispartofJournal of Clinical Oncology-
dc.titleDose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial-
dc.typeArticle-
dc.identifier.emailChiang, AK: chiangak@hku.hk-
dc.identifier.authorityChiang, AK=rp00403-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1200/JCO.21.00920-
dc.identifier.pmid34570655-
dc.identifier.scopuseid_2-s2.0-85121991086-
dc.identifier.hkuros330816-
dc.identifier.volume39-
dc.identifier.issue33-
dc.identifier.spage3716-
dc.identifier.epage3724-
dc.identifier.isiWOS:000753387700008-
dc.publisher.placeUnited States-

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