{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T08:28:24Z","timestamp":1782203304294,"version":"3.54.5"},"reference-count":29,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T00:00:00Z","timestamp":1679011200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The efficacy and safety on the addition of vincristine (VCR) and dexamethasone (DEX) pulses to maintenance therapy among childhood acute lymphoblastic leukemia (ALL) remain uncertain. Herein, we perform an open\u2010label, multicentre, randomized, phase III clinical trial that was conducted at nine major medical centers in Guangdong Province, China. Patients were randomly assigned either the conventional maintenance therapy (control group, <jats:italic>n<\/jats:italic>\u00a0=\u00a0384) or the VCR\/DEX pulse (treatment group, <jats:italic>n<\/jats:italic>\u00a0=\u00a0375). When limited to the SR cohort, 10\u2010year EFS was 82.6% (95% CI: 75.9\u201389.9) in the control group and 80.7% (95% CI: 74\u201388.1) in the treatment group (<jats:italic>p<\/jats:italic><jats:sub>non\u2010inferiority<\/jats:sub>\u00a0=\u00a0.0002). Similarly, patients with IR also demonstrated non\u2010inferiority of the treatment group to the control group in terms of 10\u2010year EFS (73.6% [95% CI: 67.6\u201380] vs. 77.6% [95% CI: 71.8\u201383.9]; <jats:italic>p<\/jats:italic><jats:sub>non\u2010inferiority<\/jats:sub>\u00a0=\u00a0.005). Among the HR cohort, compared with the control group, patients in the treatment group experienced a significant benefit in terms of 10\u2010year EFS (61.1% [95% CI: 47.7\u201378.2] vs. 72.6% [95% CI: 55.6\u201394.7], <jats:italic>p<\/jats:italic>\u00a0=\u00a0.026) and a trend toward higher 10\u2010year OS (73.8% [95% CI: 61.6\u201388.4] vs. 87.9% [95% CI: 579.2\u201397.5], <jats:italic>p<\/jats:italic>\u00a0=\u00a0.068). In the HR cohort, the total rate of drug\u2010induced liver injury and Grade 3 chemotherapy\u2010induced anemia were both lower for patients in the treatment group than in the control group (55.6% vs. 100%, <jats:italic>p<\/jats:italic>\u00a0=\u00a0.033; 37.5% vs. 60%, <jats:italic>p<\/jats:italic>\u00a0=\u00a0.036). Conversely, the total prevalence of chemotherapy\u2010induced thrombocytopenia was higher for patients in the treatment group than in the control group (88.9% vs. 40%, <jats:italic>p<\/jats:italic>\u00a0=\u00a0.027). Pediatric acute lymphoblastic leukemia with high risk is suitable to VCR\/DEX pulse during maintenance phase for the excellent outcome, while the standard\u2010to\u2010intermediate\u2010risk patients could eliminate the pulses.<\/jats:p>","DOI":"10.1002\/ajh.26910","type":"journal-article","created":{"date-parts":[[2023,3,6]],"date-time":"2023-03-06T16:24:50Z","timestamp":1678119890000},"page":"869-880","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Vincristine and dexamethasone pulses in addition to maintenance therapy among pediatric acute lymphoblastic leukemia (<scp>GD\u2010ALL<\/scp>\u20102008): An open\u2010label, multicentre, randomized, phase <scp>III<\/scp> clinical trial"],"prefix":"10.1002","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1809-0206","authenticated-orcid":false,"given":"Kun\u2010yin","family":"Qiu","sequence":"first","affiliation":[{"name":"Department of Hematology\/Oncology, Children's Medical Center, Sun Yat\u2010sen Memorial Hospital Sun Yat\u2010sen University  Guangzhou China"},{"name":"Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat\u2010Sen Memorial Hospital Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia\u2010yi","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology Guangzhou Women and Children's Medical Center  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li\u2010bin","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, the First Affiliated Hospital Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang\u2010gang","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology Shenzhen Children's Hospital  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3695-6990","authenticated-orcid":false,"given":"Lu\u2010hong","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology, Children's Medical Center, Sun Yat\u2010sen Memorial Hospital Sun Yat\u2010sen University  Guangzhou China"},{"name":"Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat\u2010Sen Memorial Hospital Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ri\u2010yang","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Huizhou Municipal Central Hospital  Huizhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui\u2010qin","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, the Third Affiliated Hospital Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong\u2010sheng","family":"Ruan","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Nanfang Hospital, Southern Medical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zi\u2010jun","family":"Zhen","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Sun Yat\u2010sen University Cancer Center  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chi\u2010kong","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Hong Kong Children Hospital and Prince of Wales Hospital The Chinese University of Hong Kong  Hong Kong 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