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A prospective multicenter study investigating rituximab combined with intensive chemotherapy in newly diagnosed pediatric patients with aggressive mature B cell non-Hodgkin lymphoma (CCCG-BNHL-2015): a report from the Chinese Children’s Cancer Group

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Abstract

The evidence for the safety and efficacy of adding rituximab to intensive chemotherapy in pediatric patients with aggressive mature B cell non-Hodgkin lymphoma/leukemia (B-NHL/B-AL) is not yet robust. In this prospective multi-institutional trial, 419 evaluable patients ≤ 16 years of age with newly diagnosed B-NHL/B-AL were enrolled. Patients were stratified into 4 risk groups according to stage, resection status, and serum lactate dehydrogenase. Patients in group R1 received 3 therapy courses in the treatment order A-B-A. Patients in group R2 received 5 courses A-B-A-B-A. Patients in group R3 received 6 courses A-BB-AA-BB-AA-BB. For patients in group R4, rituximab was added to the chemotherapy backbone for patients in R3 (A-RBB-RAA-RBB-RAA-BB). At a median follow-up of 54 months, the 4-year event-free survival (EFS) for the entire group was 88.3 ± 1.6% (76.0 ± 4.3% in the historical study). The EFS rates according to the intention-to-treat principle were 100%, 98.6 ± 1.2%, 94.2 ± 1.8%, and 73.5 ± 3.7% for patients in treatment groups R1, R2, R3, and R4, respectively (P < 0.001). There were 9 (2.1%) toxic deaths due to infection during treatment. Regarding the toxicities of rituximab, grade 3/4 thrombocytopenia, mucositis, and infection occurred in 44.0%, 33.3%, and 64.0% after courses R-BB and grade 3/4 neutropenia, thrombocytopenia, and infection occurred in 96.3%, 77.8%, and 54.1% after courses RAA. The addition of rituximab to intensive chemotherapy is feasible even in a developing country. EFS was significantly improved when compared with the historical data. clinicals.gov identifier: NCT02405676.

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Funding

This study was supported by the National Key Clinical Specialty Project.

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Authors and Affiliations

  1. Department of Hematology/Oncology, School of Medicine, Shanghai Children’s Medical Center, Shanghai Jiaotong University, Shanghai, China

    Yi-Jin Gao, Ya-Li Han & Jing-Yan Tang

  2. Department of Hematology/Oncology, Nanjing Children’s Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

    Yong-Jun Fang & Jun Wang

  3. Department of Pediatrics, Key Laboratory of Birth Defects and Related Disease of Women and Children, Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China

    Ju Gao & Xia Guo

  4. Department of Pediatric Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China

    Jie Yan

  5. Department of Pediatric Hematology/Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China

    Liang-Chun Yang & Min Xie

  6. Department of Pediatric Hematology/Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China

    Ai-Guo Liu

  7. Department of Pediatric Hematology/Oncology, Qilu Hospital of Shandong University, Jinan, Shandong, China

    Xiu-Li Ju

  8. Department of Hematology/Oncology, Children’s Hospital of Sochow University, Sochow, Jiangsu, China

    Jun Lu

Authors
  1. Yi-Jin Gao
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  2. Yong-Jun Fang
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  3. Ju Gao
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  4. Jie Yan
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  5. Liang-Chun Yang
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  6. Ai-Guo Liu
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  7. Xiu-Li Ju
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  8. Jun Lu
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  9. Ya-Li Han
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  10. Jun Wang
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  11. Min Xie
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  12. Xia Guo
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  13. Jing-Yan Tang
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Contributions

YJG and JYT designed and planned the study. YJG wrote the first draft of the manuscript. YLH analyzed the data and prepared the survival curve figure. JG involved in critical reviewing. YJG, YJF, JG, LCY, AGL, XLJ, JL, and JYT contributed to patient enrollment. YLH, JW, LCY, MX, XG, and JL involved in data collection. All authors decided to publish the paper and approved the final manuscript.

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Correspondence to Yi-Jin Gao.

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Gao, YJ., Fang, YJ., Gao, J. et al. A prospective multicenter study investigating rituximab combined with intensive chemotherapy in newly diagnosed pediatric patients with aggressive mature B cell non-Hodgkin lymphoma (CCCG-BNHL-2015): a report from the Chinese Children’s Cancer Group. Ann Hematol 101, 2035–2043 (2022). https://doi.org/10.1007/s00277-022-04904-w

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