Koji Nagafuji, Yoshikiyo Ito, Toshihiro Miyamoto, Tetsuya Eto, Tomohiko Kamimura, Koji Kato, Yasuhiko Miyazaki, Atsuhi Wake, Kentaro Kohno, Ken Takase, Yutaka Imamura, Naoyuki Uchida, Kazuki Tanimoto, Noriaki Kawano, Toshiro Kurokawa, Yukio Kondo, Tomoaki Fujisaki, Junichi Tsukada, Koji Yonemoto, Koichi Akashi
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Post-induction, 96.7% achieved complete remission (CR). The 3-year event-free survival (EFS) and overall survival (OS) were 51% and 76%, respectively. Patients undergoing allo-HSCT in CR1 had improved outcomes, with a 3-year EFS of 64% and OS of 87%. MRD-negative patients before transplantation exhibited superior survival (EFS: 71% vs. 29%; OS: 94% vs. 57%). Comparison with the MRD2008 trial revealed similar outcomes, with the MRD2014 trial achieving a 3-year EFS of 51% and OS of 76% vs. 52% and 84% in MRD2008. Although not statistically significant, the MRD2014 trial showed trends of increased relapse (CIR: 39% vs. 26%, p = 0.305) and reduced non-relapse mortality (NRM: 10% vs. 21%, p = 0.181).</p><p><strong>Conclusion: </strong>The ALL/MRD2014 trial underscores the importance of MRD status and allo-HSCT in Ph+ ALL. 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Post-induction, 96.7% achieved complete remission (CR). The 3-year event-free survival (EFS) and overall survival (OS) were 51% and 76%, respectively. Patients undergoing allo-HSCT in CR1 had improved outcomes, with a 3-year EFS of 64% and OS of 87%. MRD-negative patients before transplantation exhibited superior survival (EFS: 71% vs. 29%; OS: 94% vs. 57%). Comparison with the MRD2008 trial revealed similar outcomes, with the MRD2014 trial achieving a 3-year EFS of 51% and OS of 76% vs. 52% and 84% in MRD2008. Although not statistically significant, the MRD2014 trial showed trends of increased relapse (CIR: 39% vs. 26%, p = 0.305) and reduced non-relapse mortality (NRM: 10% vs. 21%, p = 0.181).</p><p><strong>Conclusion: </strong>The ALL/MRD2014 trial underscores the importance of MRD status and allo-HSCT in Ph+ ALL. 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引用次数: 0
摘要
目的：评估持续达沙替尼改善成年BCR::ABL1 ALL患者预后的疗效。方法：与MRD2008试验相比，前瞻性、多中心ALL/MRD2014试验引入了一种改进的方案，包括持续使用达沙替尼和降低化疗强度。结果：入组的164例成年ALL患者（2014-2019年）中，61例philadelphia阳性（Ph+）(中位年龄50岁；男性38人，女性23人)。诱导后，96.7%达到完全缓解（CR）。3年无事件生存期（EFS）和总生存期（OS）分别为51%和76%。在CR1中接受同种异体造血干细胞移植的患者有改善的结果，3年EFS为64%，OS为87%。移植前mrd阴性患者表现出更高的生存率(EFS: 71% vs. 29%；OS: 94% vs. 57%)。与MRD2008试验的比较显示出类似的结果，MRD2014试验的3年EFS为51%，OS为76%，而MRD2008试验为52%和84%。虽然没有统计学意义，但MRD2014试验显示复发率增加（CIR: 39%对26%，p = 0.305）和非复发死亡率降低（NRM: 10%对21%，p = 0.181）的趋势。结论：ALL/MRD2014试验强调了Ph+ ALL中MRD状态和同种异体造血干细胞移植的重要性。持续以达沙替尼为基础的方案在mrd阴性患者中提供良好的结果。试验注册：本研究已在UMIN临床试验注册中心（UMIN- ctr）注册，编号为UMIN000012382。
Clinical Impact of Continuous Dasatinib Administration on the Prognosis of Patients With BCR::ABL1 Acute Lymphoblastic Leukemia: Result of the Prospective MRD2014 Study Conducted by Fukuoka Blood and Marrow Transplantation Group (FBMTG).
Aim: To assess the efficacy of continuous dasatinib in improving outcomes for adult patients with BCR::ABL1 ALL.
Methods: The prospective, multicenter ALL/MRD2014 trial introduced a modified protocol compared to the MRD2008 trial, incorporating continuous dasatinib use and reduced chemotherapy intensity.
Results: Among the 164 adult ALL patients enrolled (2014-2019), 61 were Philadelphia-positive (Ph+) (median age 50 years; 38 males, 23 females). Post-induction, 96.7% achieved complete remission (CR). The 3-year event-free survival (EFS) and overall survival (OS) were 51% and 76%, respectively. Patients undergoing allo-HSCT in CR1 had improved outcomes, with a 3-year EFS of 64% and OS of 87%. MRD-negative patients before transplantation exhibited superior survival (EFS: 71% vs. 29%; OS: 94% vs. 57%). Comparison with the MRD2008 trial revealed similar outcomes, with the MRD2014 trial achieving a 3-year EFS of 51% and OS of 76% vs. 52% and 84% in MRD2008. Although not statistically significant, the MRD2014 trial showed trends of increased relapse (CIR: 39% vs. 26%, p = 0.305) and reduced non-relapse mortality (NRM: 10% vs. 21%, p = 0.181).
Conclusion: The ALL/MRD2014 trial underscores the importance of MRD status and allo-HSCT in Ph+ ALL. Continuous dasatinib-based regimens offer favorable outcomes in MRD-negative patients.
Trial registration: This study was registered with the UMIN Clinical Trials Registry (UMIN-CTR), number UMIN000012382.
期刊介绍：
European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.
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