Comparison of haplo-SCT and chemotherapy for young adults with standard-risk Ph-negative acute lymphoblastic leukemia in CR1

Meng Lv, Qian Jiang, Dao-Bin Zhou, Yu Hu, Dai-Hong Liu, De-Pei Wu, Jing-Bo Wang, Hao Jiang, Jing Wang, Ying-Jun Chang, Yu Wang, Xiao-Hui Zhang, Lan-Ping Xu, Kai-Yan Liu, Xiao-Jun Huang, Meng Lv, Qian Jiang, Dao-Bin Zhou, Yu Hu, Dai-Hong Liu, De-Pei Wu, Jing-Bo Wang, Hao Jiang, Jing Wang, Ying-Jun Chang, Yu Wang, Xiao-Hui Zhang, Lan-Ping Xu, Kai-Yan Liu, Xiao-Jun Huang

Abstract

Human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) as a postremission treatment for standard risk Philadelphia chromosome-negative acute lymphoblastic leukemia (SR Ph-ALL) in the first complete remission (CR1) has not been defined. In this multicenter, phase 3 study (NCT02042690), of the 131 consecutive Ph-ALL young adult patients (YA, aged 18-39 years) without high-risk features who achieved CR1, 114 patients without HLA-matched donors received consolidation with an adult chemotherapy regimen (n = 55) or haplo-SCT (n = 59). In the landmark analysis, haplo-SCT resulted in a lower 2-year cumulative incidence of relapse (CIR, 12.8% vs 46.7%, P = 0.0017) and superior 2-year leukemia-free survival (LFS, 80.9% vs 51.1%, P = 0.0116) and 2-year overall survival (OS, 91.2% vs 75.7 [64.8-93.2] %, P = 0.0408) than chemotherapy. In the time-dependent multivariate analysis with propensity score adjustment, postremission treatment (haplo-SCT vs chemotherapy) was an independent risk factor for the CIR (HR 0.195, 95% CI 0.076-0.499, P = 0.001), LFS (HR 0.297, 95% CI 0.131-0.675, P = 0.003), and OS (HR 0.346, 95% CI 0.140-0.853, P = 0.011). In all subgroups, CIR was lower in haplo-SCT. Myeloablative haplo-SCT with ATG+G-CSF might be one of the preferred therapies for YA patients with standard-risk Ph-ALL. TRIAL REGISTRATION: ClinicalTrials.gov. Registered on 23 January 2014, https://ichgcp.net/clinical-trials-registry/NCT02042690.

Keywords: Adult chemotherapy; Haplo-SCT; Ph-negative acute lymphoblastic leukemia.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Comparison between chemotherapy and haplo-SCT with landmark. a Cumulative incidence of relapse (CIR). b Non-relapse mortality (NRM). c Leukemia-free survival (LFS). d Overall survival (OS)
Fig. 2
Fig. 2
Forest plot of time-dependent multivariable Cox regression model. a Cumulative incidence of relapse (CIR). b Non-relapse mortality (NRM). c Leukemia-free survival (LFS). d Overall survival (OS)

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Source: PubMed

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