Risk-adjusted therapy for pediatric non-T cell ALL improves outcomes for standard risk patients: results of JACLS ALL-02.,Blood Cancer Journal

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Risk-adjusted therapy for pediatric non-T cell ALL improves outcomes for standard risk patients: results of JACLS ALL-02.
Blood Cancer Journal ( IF 12.9 ) Pub Date : 2020-02-27 , DOI: 10.1038/s41408-020-0287-4
Daiichiro Hasegawa ₁ , Toshihiko Imamura _{2,

3} , Keiko Yumura-Yagi ₄ , Yoshihiro Takahashi ₅ , Ikuya Usami _{3,

6} , So-Ichi Suenobu ₇ , Shinichiro Nishimura ₈ , Nobuhiro Suzuki ₉ , Yoshiko Hashii ₁₀ , Takao Deguchi ₁₁ , Akiko Moriya-Saito ₃ , Koji Kato ₁₂ , Yoshiyuki Kosaka ₁ , Masahiro Hirayama ₁₁ , Akihiro Iguchi ₁₃ , Hirohide Kawasaki ₁₄ , Hiroki Hori ₁₁ , Atsushi Sato ₁₅ , Tooru Kudoh ₁₆ , Tatsutoshi Nakahata ₁₇ , Megumi Oda ₁₈ , Junichi Hara ₁₉ , Keizo Horibe ₃ ,

Affiliation

Department of Hematology/Oncology, Hyogo Prefectural Children's Hospital, Kobe, Japan.
Department of Pediatrics, Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.
Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yumura Clinic, Osaka, Japan.
Department of Pediatrics, Aomori Prefectural Central Hospital, Aomori, Japan.
Department of Pediatric Hematology and Oncology, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.
Division of General Pediatrics and Emergency Medicine, Department of Pediatrics, Oita University, Oita, Japan.
Department of Pediatrics, Hiroshima University Hospital, Hiroshima, Japan.
Department of Pediatrics, Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo, Japan.
Department of Pediatrics, Osaka University, Suita, Japan.
Department of Pediatrics, Mie University, Tsu, Japan.
Department of Hematology Oncology, Children's Medical Center, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.
Department of Pediatrics, Hokkaido University Hospital, Sapporo, Japan.
Department of Pediatrics Kansai Medical University, Hirakata, Japan.
Department of Hematology/Oncology, Miyagi Children's Hospital, Sendai, Japan.
Saiseikai Nishiotaru Hospital, Otaru, Japan.
Department of Clinical Application, Center for iPS Cell Research and Application (CiRA), Kyoto University, Kyoto, Japan.
Department of Pediatrics, Okayama University, Okayama, Japan.
Department of Pediatric Hematology/Oncology, Osaka City General Hospital, Osaka, Japan.

This study was a second multicenter trial on childhood ALL by the Japan Childhood Leukemia Study Group (JACLS) to improve outcomes in non-T ALL. Between April 2002 and March 2008, 1138 children with non-T ALL were enrolled in the JACLS ALL-02 trial. Patients were stratified into three groups using age, white blood cell count, unfavorable genetic abnormalities, and treatment response: standard risk (SR), high risk (HR), and extremely high risk (ER). Prophylactic cranial radiation therapy (PCRT) was abolished except for CNS leukemia. Four-year event-free survival (4yr-EFS) and 4-year overall survival (4yr-OS) rates for all patients were 85.4% ± 1.1% and 91.2% ± 0.9%, respectively. Risk-adjusted therapy resulted in 4yr-EFS rates of 90.4% ± 1.4% for SR, 84.9% ± 1.6% for HR, and 66.5% ± 4.0% for ER. Based on NCI risk classification, 4yr-EFS rates were 88.2% in NCI-SR and 76.4% in NCI-HR patients, respectively. Compared to previous trial ALL-97, 4yr-EFS of NCI-SR patients was significantly improved (88.2% vs 81.2%, log rank p = 0.0004). The 4-year cumulative incidence of isolated (0.9%) and total (1.5%) CNS relapse were significantly lower than those reported previously. In conclusion, improved EFS in NCI-SR patients and abolish of PCRT was achieved in ALL-02.

中文翻译：

儿科非T细胞ALL的风险调整疗法可改善标准风险患者的预后：JACLS ALL-02的结果。

这项研究是日本儿童白血病研究小组（JACLS）进行的第二项针对儿童ALL的多中心试验，旨在改善非T ALL的结局。在2002年4月至2008年3月之间，共有1138名非T ALL儿童入选了JACLS ALL-02试验。根据年龄，白细胞计数，不利的遗传异常和治疗反应将患者分为三类：标准风险（SR），高风险（HR）和极高风险（ER）。除中枢神经系统白血病外，已取消了预防性颅脑放射疗法（PCRT）。所有患者的四年无事件生存率（4yr-EFS）和四年总生存率（4yr-OS）分别为85.4％±1.1％和91.2％±0.9％。经过风险调整的治疗后，SR的4yr-EFS率为90.4％±1.4％，HR的为84.9％±1.6％，ER的为66.5％±4.0％。根据NCI风险分类，NCI-SR患者的4yr-EFS发生率分别为88.2％和NCI-HR患者为76.4％。与先前的ALL-97试验相比，NCI-SR患者的4yr-EFS显着改善（88.2％对81.2％，对数秩p = 0.0004）。孤立的中枢神经系统复发的4年累积发生率（0.9％）和总CNS复发（1.5％）显着低于以前的报告。总之，在ALL-02中，NCI-SR患者的EFS改善，PCRT取消。

更新日期：2020-02-27

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