Yasuyuki Arai, Ruta Brazauskas, Naya He, A. Samer Al-Homsi, Saurabh Chhabra, Minoo Battiwalla, Masamitsu Yanada, Amir Steinberg, Miguel Angel Diaz Perez, Sanghee Hong, Junya Kanda, Asad Bashey, Haydar A. Frangoul, Sherif M. Badawy, Leo F. Verdonck, Hillard M. Lazarus, Jean A. Yared, Hasan Hashem, Akshay Sharma, Mahmoud Aljurf, Ajoy L. Dias, Muhammad Bilal Abid, Baldeep Wirk, César O. Freytes, Amer M. Zeidan, Usama Gergis, Amer Beitinjaneh, Medhat Askar, Jeffrey J. Pu, Leslie E. Lehmann, Hemalatha G. Rangarajan, William A. Wood, Shahrukh Hashmi, Shingo Yano, Shinichi Kako, Yukiyasu Ozawa, Noriko Doki, Yoshinobu Kanda, Takahiro Fukuda, Yuta Katayama, Tatsuo Ichinohe, Junji Tanaka, Takanori Teshima, Shinichiro Okamoto, Yoshiko Atsuta, Wael Saber
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Wood, Shahrukh Hashmi, Shingo Yano, Shinichi Kako, Yukiyasu Ozawa, Noriko Doki, Yoshinobu Kanda, Takahiro Fukuda, Yuta Katayama, Tatsuo Ichinohe, Junji Tanaka, Takanori Teshima, Shinichiro Okamoto, Yoshiko Atsuta, Wael Saber","doi":"10.1002/jha2.70061","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>In this study, we compared outcomes of intensified myeloablative conditioning regimens using large registry data from Japan (Japanese Society for Transplantation and Cellular Therapy) and the United States (Center for International Blood and Marrow Transplant Research).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Adult patients who underwent their first myeloablative allogeneic hematopoietic stem cell transplantation (HSCT) for acute leukemia in remission between 2010 and 2018 using conditioning regimens of cyclophosphamide plus total-body irradiation (CY/TBI), CY/TBI+cytarabine (AraC), or CY/TBI+etoposide (VP16) were included.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The acute myeloid leukemia (AML) cohort (<i>N</i> = 480, 38.8%) indicated that overall survival (OS) was poorer in CY/TBI+AraC (hazard ratio [HR] 1.46, <i>p</i> < 0.001) and CY/TBI+VP16 (HR 1.39, <i>p</i> = 0.059) compared to CY/TBI. Relapse was not suppressed, while treatment-related mortality (TRM) was significantly higher (HR 1.78 and 1.74, <i>p</i> < 0.001 and 0.018, respectively). In the acute lymphoblastic leukemia (ALL) cohort (<i>N</i> = 3901, 61.2%), OS was comparable among these regimens. With intensified regimens, relapse was significantly suppressed in CY/TBI+VP16 (HR 0.74, <i>p</i> = 0.005), while TRM was higher (HR 1.21, <i>p</i> = 0.077). No interactions were observed regarding the country.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>In AML adding AraC and VP16 to CY/TBI had an adverse effect on OS. Conversely, in ALL, adding VP16 or AraC to CY/TBI did not affect survival, but the addition of VP16 reduced the risk of relapse.</p>\n </section>\n \n <section>\n \n <h3> Clinical Trial Registration</h3>\n \n <p>The authors have confirmed clinical trial registration is not needed for this submission.</p>\n </section>\n </div>","PeriodicalId":72883,"journal":{"name":"EJHaem","volume":"6 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jha2.70061","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Total-Body Irradiation-based Intensified Myeloablative Regimens for Acute Leukemia—An International Collaborative Study\",\"authors\":\"Yasuyuki Arai, Ruta Brazauskas, Naya He, A. 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引用次数: 0
摘要
在这项研究中，我们使用来自日本（日本移植和细胞治疗学会）和美国（国际血液和骨髓移植研究中心）的大量注册数据，比较了强化骨髓清除调节方案的结果。方法纳入2010年至2018年间接受首次清髓异基因造血干细胞移植（HSCT）治疗急性白血病缓解的成人患者，治疗方案为环磷酰胺加全身照射（CY/TBI）、CY/TBI+阿糖胞苷（AraC）或CY/TBI+依托泊苷（VP16）。结果急性髓性白血病（AML）队列（N = 480, 38.8%）显示CY/TBI+AraC组总生存期（OS）较差(风险比[HR] 1.46, p <；0.001)和CY/TBI+VP16 （HR 1.39, p = 0.059）。复发未被抑制，但治疗相关死亡率（TRM）显著升高(HR 1.78和1.74,p <；分别为0.001和0.018)。在急性淋巴细胞白血病（ALL）队列中（N = 3901, 61.2%），这些方案之间的总生存率具有可比性。随着方案的加强，CY/TBI+VP16的复发明显受到抑制（HR 0.74, p = 0.005），而TRM升高（HR 1.21, p = 0.077）。没有观察到有关国家的互动。结论急性髓系白血病患者CY/TBI中加入AraC和VP16对OS有不良影响。相反，在ALL中，在CY/TBI中添加VP16或AraC不影响生存，但添加VP16降低了复发的风险。临床试验注册作者已确认该提交不需要临床试验注册。
Efficacy of Total-Body Irradiation-based Intensified Myeloablative Regimens for Acute Leukemia—An International Collaborative Study
Background
In this study, we compared outcomes of intensified myeloablative conditioning regimens using large registry data from Japan (Japanese Society for Transplantation and Cellular Therapy) and the United States (Center for International Blood and Marrow Transplant Research).
Methods
Adult patients who underwent their first myeloablative allogeneic hematopoietic stem cell transplantation (HSCT) for acute leukemia in remission between 2010 and 2018 using conditioning regimens of cyclophosphamide plus total-body irradiation (CY/TBI), CY/TBI+cytarabine (AraC), or CY/TBI+etoposide (VP16) were included.
Results
The acute myeloid leukemia (AML) cohort (N = 480, 38.8%) indicated that overall survival (OS) was poorer in CY/TBI+AraC (hazard ratio [HR] 1.46, p < 0.001) and CY/TBI+VP16 (HR 1.39, p = 0.059) compared to CY/TBI. Relapse was not suppressed, while treatment-related mortality (TRM) was significantly higher (HR 1.78 and 1.74, p < 0.001 and 0.018, respectively). In the acute lymphoblastic leukemia (ALL) cohort (N = 3901, 61.2%), OS was comparable among these regimens. With intensified regimens, relapse was significantly suppressed in CY/TBI+VP16 (HR 0.74, p = 0.005), while TRM was higher (HR 1.21, p = 0.077). No interactions were observed regarding the country.
Conclusion
In AML adding AraC and VP16 to CY/TBI had an adverse effect on OS. Conversely, in ALL, adding VP16 or AraC to CY/TBI did not affect survival, but the addition of VP16 reduced the risk of relapse.
Clinical Trial Registration
The authors have confirmed clinical trial registration is not needed for this submission.
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