Vincristine and dexamethasone pulses in addition to maintenance therapy among pediatric acute lymphoblastic leukemia (GD‐ALL‐2008): An open‐label, multicentre, randomized, phase III clinical trial

Author:

Qiu Kun‐yin12ORCID,Wang Jia‐yi3,Huang Li‐bin4,Li Chang‐gang5,Xu Lu‐hong12ORCID,Liu Ri‐yang6,Chen Hui‐qin7,Ruan Yong‐sheng8,Zhen Zi‐jun9,Li Chi‐kong10,Fang Jian‐pei12ORCID

Affiliation:

1. Department of Hematology/Oncology, Children's Medical Center, Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou China

2. Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat‐Sen Memorial Hospital Sun Yat‐Sen University Guangzhou China

3. Department of Hematology/Oncology Guangzhou Women and Children's Medical Center Guangzhou China

4. Department of Paediatrics, the First Affiliated Hospital Sun Yat‐sen University Guangzhou China

5. Department of Hematology/Oncology Shenzhen Children's Hospital Shenzhen China

6. Department of Paediatrics Huizhou Municipal Central Hospital Huizhou China

7. Department of Paediatrics, the Third Affiliated Hospital Sun Yat‐sen University Guangzhou China

8. Department of Paediatrics Nanfang Hospital, Southern Medical University Guangzhou China

9. Department of Paediatrics Sun Yat‐sen University Cancer Center Guangzhou China

10. Department of Paediatrics, Hong Kong Children Hospital and Prince of Wales Hospital The Chinese University of Hong Kong Hong Kong China

Abstract

AbstractThe 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‐label, 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, n = 384) or the VCR/DEX pulse (treatment group, n = 375). When limited to the SR cohort, 10‐year EFS was 82.6% (95% CI: 75.9–89.9) in the control group and 80.7% (95% CI: 74–88.1) in the treatment group (pnon‐inferiority = .0002). Similarly, patients with IR also demonstrated non‐inferiority of the treatment group to the control group in terms of 10‐year EFS (73.6% [95% CI: 67.6–80] vs. 77.6% [95% CI: 71.8–83.9]; pnon‐inferiority = .005). Among the HR cohort, compared with the control group, patients in the treatment group experienced a significant benefit in terms of 10‐year EFS (61.1% [95% CI: 47.7–78.2] vs. 72.6% [95% CI: 55.6–94.7], p = .026) and a trend toward higher 10‐year OS (73.8% [95% CI: 61.6–88.4] vs. 87.9% [95% CI: 579.2–97.5], p = .068). In the HR cohort, the total rate of drug‐induced liver injury and Grade 3 chemotherapy‐induced anemia were both lower for patients in the treatment group than in the control group (55.6% vs. 100%, p = .033; 37.5% vs. 60%, p = .036). Conversely, the total prevalence of chemotherapy‐induced thrombocytopenia was higher for patients in the treatment group than in the control group (88.9% vs. 40%, p = .027). Pediatric acute lymphoblastic leukemia with high risk is suitable to VCR/DEX pulse during maintenance phase for the excellent outcome, while the standard‐to‐intermediate‐risk patients could eliminate the pulses.

Publisher

Wiley

Subject

Hematology

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