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

被引：25

作者：

Burke, G. A. Amos ^{[1
]}

Minard-Colin, Veronique ^{[2
]}

Auperin, Anne ^{[3
]}

Alexander, Sarah ^{[4
]}

Pillon, Marta ^{[5
]}

Delgado, Rafael ^{[6
]}

Zsiros, Jozsef ^{[7
]}

Uyttebroeck, Anne ^{[8
]}

Dartigues, Peggy ^{[9
]}

Miles, Rodney R. ^{[10
,11
,12
]}

Kazanowska, Bernarda ^{[13
]}

Chiang, Alan K. ^{[14
]}

Haouy, Stephanie ^{[15
]}

Bollard, Catherine M. ^{[16
,17
]}

Csoka, Monika ^{[18
]}

Wheatley, Keith ^{[19
]}

Barkauskas, Donald A. ^{[20
]}

Adamson, Peter C. ^{[21
]}

Vassal, Gilles ^{[22
]}

Patte, Catherine ^{[2
]}

Gross, Thomas G. ^{[23
]}

机构：

[1] Cambridge Univ Hosp NHS Fdn Trust, Addenbrookes Hosp, Dept Paediat Haematol Oncol & Palliat Care, Cambridge, England

[2] Univ Paris Saclay, Dept Pediat & Adolescent Oncol, INSERM 1015, Gustave Roussy, Villejuif, France

[3] Univ Paris Saclay, Unit Biostat & Epidemiol, Labeled Ligue Canc, Gustave Roussy,Oncostat 1018,INSERM, Villejuif, France

[4] Hosp Sick Children, Div Haematol Oncol, Toronto, ON, Canada

[5] Univ Padua, Pediat Hematol & Oncol, Padua, Italy

[6] Univ Valencia, Pediat Hematol & Oncol, Valencia, Spain

[7] Princess Maxima Ctr Pediat Oncol, Utrecht, Netherlands

[8] Univ Hosp Leuven, Dept Pediat Hematol & Oncol, Leuven, Belgium

[9] Univ Paris Saclay, Dept Biopathol, Gustave Roussy, Villejuif, France

[10] Dept Pathol, Salt Lake City, UT USA

[11] ARUP Labs, Salt Lake City, UT USA

[12] Huntsman Canc Inst, Salt Lake City, UT USA

[13] Wroclaw Med Univ, Dept Pediat Bone Marrow Transplantat Oncol & Hema, Wroclaw, Poland

[14] Univ Hong Kong, Queen Mary Hosp, Li Ka Shing Fac Med, Dept Paediat & Adolescent Med,Pok Fu Lam, Hong Kong, Peoples R China

[15] CHU Arnaud de Villeneuve, Dept Paediat Haematol, Oncol, Montpellier, France

[16] Childrens Natl Hlth Syst, Ctr Canc & Immunol Res, Washington, DC USA

[17] George Washington Univ, Washington, DC USA

[18] Semmelweis Univ, Pediat Hematol & Oncol, Budapest, Hungary

[19] Univ Birmingham, Coll Med & Dent Sci, Inst Canc & Genom Sci, Canc Res UK Clin Trials Unit, Birmingham, W Midlands, England

[20] Univ Southern Calif, Keck Sch Med, Dept Prevent Med, Los Angeles, CA 90007 USA

[21] Sanofi, Oncol Dev & Pediat Innovat, Cambridge, MA USA

[22] Univ Paris Saclay, Dept Clin Res, Gustave Roussy, Villejuif, France

[23] Childrens Hosp Colorado, Ctr Canc & Blood Dis, Dept Pediat, Aurora, CO USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2021年 / 39卷 / 33期

关键词：

NON-HODGKIN-LYMPHOMA; EPOCH-R; CHEMOTHERAPY; CHILDHOOD; FEATURES; OUTCOMES; CHOP;

D O I：

10.1200/JCO.21.00920

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSE 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. (C) 2021 by American Society of Clinical Oncology

引用

页码：3716 / +

页数：13

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