Pulse therapy with vincristine and dexamethasone for childhood acute lymphoblastic leukaemia (CCCG-ALL-2015): an open-label, multicentre, randomised, phase 3, non-inferiority trial

Yang, Wenyu; Cai, Jiaoyang; Shen, Shuhong; Gao, Ju; Yu, Jianhua; Hu, Shaoyan; Jiang, Hua; Fang, Yongjun; Liang, Chaozhao; Ju, Xiuli; Wang, Xuedong; Zhai, Xiaowen; Tian, Xin; Wang, Ningling; Liu, Aiguo; Jiang, Hui; Jin, Runming; Sun, Lirong; Yang, Minghua; Leung, Alex Wing Kwan; Pan, Kaili; Zhang, Yingchi; Chen, Jing; Zhu, Yiping; Zhang, Hui; Li, Chunfu; Yang, Jun J.; Cheng, Cheng; Li, Chi Kong; Tang, Jingyan; Zhu, Xiaofan; Pui, Ching‐Hon

doi:10.1016/s1470-2045(21)00328-4

Cited by 62 publications

(73 citation statements)

References 29 publications

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“…T-cell lineage features of leukemic cells were determined according to standard techniques ( 11 , 12 ) ( Supplementary Table 1 ). Enrollment in the CCCG-ALL-2015 classification/biology study was required for study entry ( 13 , 14 ). Minimal residual disease (MRD) testing was performed at our hospital by flow cytometry using established methodologies ( 12 ) on days 19 and 46 of treatment ( Supplementary Table 2 ).…”

Section: Methodsmentioning

confidence: 99%

A Novel Risk Defining System for Pediatric T-Cell Acute Lymphoblastic Leukemia From CCCG-ALL-2015 Group

et al. 2022

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ObjectiveT-cell acute lymphoblastic leukemia (T-ALL) is a rare hematological malignancy with a poor prognosis. The present study aims to identify the precise risk grouping of children with T-ALL.MethodsWe analyzed the outcomes for 105 consecutive patients treated using the Chinese Children’s Cancer Group ALL-2015 (CCCG-ALL-2015) protocol registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-14005706) between 2015 and 2020 in our center. Nine out of 21 clinical and biological indicators were selected for the new scoring system based on the analysis in this study.ResultsThe 5-year overall survival (OS), event-free survival (EFS), and disease-free survival (DFS) rates for the 105 patients were 83.1 ± 4.8%, 72.4 ± 5.6%, and 78.4 ± 3.6%, respectively. Based on the new scoring system, 90 evaluable children were regrouped into low-risk (n=22), intermediate-risk (n=50), and high-risk (n=18) groups. The 5-year survival (OS, EFS, and RFS) rates for all patients in the low-risk group were 100%, significantly higher than the rates for those in the intermediate-risk group (91.2 ± 5.2%, 74.4 ± 8.6%, and 82.5 ± 6.2%, respectively) and high-risk group (59.0 ± 13.2%, 51.9 ± 12.4%, and 51.9 ± 12.4%, respectively) (all P values < 0.01).ConclusionThe CCCG-ALL-2015 program significantly improved the treatment outcomes for childhood T-ALL as compared with the CCCG-ALL-2008 protocol. Our new refined risk grouping system showed better stratification among pediatric T-ALL patients and better potential in evaluating therapeutic efficacy.

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Section: Methodsmentioning

confidence: 99%

A Novel Risk Defining System for Pediatric T-Cell Acute Lymphoblastic Leukemia From CCCG-ALL-2015 Group

et al. 2022

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“…According to CCCGALL2015 protocol [ 17 , 18 ], induction chemotherapy of “VDLD (vincristine + daunorubicin + PEG-Asp + Prednisone) + CAM (cyclophosphamide + cytarabine + mercaptopurine)” was 36–40 days in total, and the recovery period after chemotherapy was about 10–20 days. Therefore, the scope of this study was defined as the patient’s situation from the start of induction chemotherapy to 60 days.…”

Section: Methodsmentioning

confidence: 99%

Characteristics in gut microbiome is associated with chemotherapy-induced pneumonia in pediatric acute lymphoblastic leukemia

et al. 2021

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Background Children with acute lymphoblastic leukemia (ALL) undergoing chemotherapy experience a relatively high risk of infection. And the disturbance of gut microbiota is generally believed to impair intestinal barrier function and may induce bacterial infections and inflammation. The study aimed to investigate the alterations in the gut microbiota and assess its relationship with chemotherapy-induced pneumonia in pediatric ALL patients. Methods We conducted a case–control study with 14 cases affected by pneumonia and 44 unaffected subjects and characterized the physiological parameters and gut microbiota by microarray-based technique. Results There were significant differences in α- and β-diversity in the affected group compared with the control group. At species level, the LEfSe analysis revealed that Enterococcus malodoratus, Ochrobactrum anthropi and Actinomyces cardiffensis were significantly abundant in the affected subjects. A receiver operating characteristic (ROC) curve yielded the area under the curve (AUC) of 0.773 for classification between the two groups. In addition, the Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways involved in the bacterial secretion system were more enriched in the affected group than in the control group. Conclusions Gut microbiota alteration was associated with chemotherapy-induced pneumonia in pediatric ALL patients, which provided a new perspective on the personalized clinical care of pediatric ALL.

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“…The International BFM (I-BFM) Study Group prospective randomized multi-protocols study found that IR patients who received intensive ALL BFM-backbone protocols did not benefit from six pulses of VCR/Dexa during MT [74]. A recent large randomized trial from China showed that omitting these pulses in LR patients did not impact survival outcomes [75]. However, the EORTC ALL 58951-trial showed better survival [76].…”

Section: Vcr/steroid Pulsesmentioning

confidence: 99%

Curing the Curable: Managing Low-Risk Acute Lymphoblastic Leukemia in Resource Limited Countries

Lee

Yeoh

2021

JCM

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Although childhood acute lymphoblastic leukemia (ALL) is curable, global disparities in treatment outcomes remain. To reduce these global disparities in low-middle income countries (LMIC), a paradigm shift is needed: start with curing low-risk ALL. Low-risk ALL, which accounts for >50% of patients, can be cured with low-toxicity therapies already defined by collaborative studies. We reviewed the components of these low-toxicity regimens in recent clinical trials for low-risk ALL and suggest how they can be adopted in LMIC. In treating childhood ALL, the key is risk stratification, which can be resource stratified. NCI standard-risk criteria (age 1–10 years, WBC < 50,000/uL) is simple yet highly effective. Other favorable features such as ETV6-RUNX1, hyperdiploidy, early peripheral blood and bone marrow responses, and simplified flow MRD at the end of induction can be added depending on resources. With limited supportive care in LMIC, more critical than relapse is treatment-related morbidity and mortality. Less intensive induction allows early marrow recovery, reducing the need for intensive supportive care. Other key elements in low-toxicity protocol designs include: induction steroid type; high-dose versus low-dose escalating methotrexate; judicious use of anthracyclines; and steroid pulses during maintenance. In summary, the first effective step in curing ALL in LMIC is to focus on curing low-risk ALL with less intensive therapy and less toxicity.

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Pulse therapy with vincristine and dexamethasone for childhood acute lymphoblastic leukaemia (CCCG-ALL-2015): an open-label, multicentre, randomised, phase 3, non-inferiority trial

Cited by 62 publications

References 29 publications

A Novel Risk Defining System for Pediatric T-Cell Acute Lymphoblastic Leukemia From CCCG-ALL-2015 Group

A Novel Risk Defining System for Pediatric T-Cell Acute Lymphoblastic Leukemia From CCCG-ALL-2015 Group

Characteristics in gut microbiome is associated with chemotherapy-induced pneumonia in pediatric acute lymphoblastic leukemia

Curing the Curable: Managing Low-Risk Acute Lymphoblastic Leukemia in Resource Limited Countries

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