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Abstract
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.
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; Yumura-Yagi Keiko 3 ; Takahashi, Yoshihiro 4 ; Usami Ikuya 5 ; So-ichi, Suenobu 6 ; Nishimura Shinichiro 7 ; Suzuki, Nobuhiro 8 ; Hashii Yoshiko 9 ; Deguchi Takao 10 ; Moriya-Saito Akiko 11 ; Kato Koji 12 ; Kosaka Yoshiyuki 13 ; Hirayama Masahiro 10
; Iguchi Akihiro 14
; Kawasaki Hirohide 15 ; Hori Hiroki 10 ; Sato, Atsushi 16 ; Kudoh Tooru 17 ; Nakahata Tatsutoshi 18 ; Oda Megumi 19 ; Hara Junichi 20 ; Horibe Keizo 11 1 Hyogo Prefectural Children’s Hospital, Department of Hematology/Oncology, Kobe, Japan
2 Graduate School of Medical Science, Department of Pediatrics, Kyoto Prefectural University of Medicine, Kyoto, Japan; National Hospital Organization Nagoya Medical Center, Clinical Research Center, Nagoya, Japan (GRID:grid.410840.9) (ISNI:0000 0004 0378 7902)
3 Yumura Clinic, Osaka, Japan (GRID:grid.410840.9)
4 Aomori Prefectural Central Hospital, Department of Pediatrics, Aomori, Japan (GRID:grid.413825.9) (ISNI:0000 0004 0378 7152)
5 National Hospital Organization Nagoya Medical Center, Clinical Research Center, Nagoya, Japan (GRID:grid.410840.9) (ISNI:0000 0004 0378 7902); Hyogo Prefectural Amagasaki General Medical Center, Department of Pediatric Hematology and Oncology, Hyogo, Japan (GRID:grid.410840.9)
6 Oita University, Division of General Pediatrics and Emergency Medicine, Department of Pediatrics, Oita, Japan (GRID:grid.412334.3) (ISNI:0000 0001 0665 3553)
7 Hiroshima University Hospital, Department of Pediatrics, Hiroshima, Japan (GRID:grid.470097.d) (ISNI:0000 0004 0618 7953)
8 Hokkaido Medical Center for Child Health and Rehabilitation, Department of Pediatrics, Sapporo, Japan (GRID:grid.470097.d)
9 Osaka University, Department of Pediatrics, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971)
10 Mie University, Department of Pediatrics, Tsu, Japan (GRID:grid.260026.0) (ISNI:0000 0004 0372 555X)
11 National Hospital Organization Nagoya Medical Center, Clinical Research Center, Nagoya, Japan (GRID:grid.410840.9) (ISNI:0000 0004 0378 7902)
12 Japanese Red Cross Nagoya First Hospital, Department of Hematology Oncology, Children’s Medical Center, Nagoya, Japan (GRID:grid.414932.9) (ISNI:0000 0004 0378 818X)
13 Hyogo Prefectural Children’s Hospital, Department of Hematology/Oncology, Kobe, Japan (GRID:grid.414932.9)
14 Hokkaido University Hospital, Department of Pediatrics, Sapporo, Japan (GRID:grid.412167.7) (ISNI:0000 0004 0378 6088)
15 Department of Pediatrics Kansai Medical University, Hirakata, Japan (GRID:grid.410783.9) (ISNI:0000 0001 2172 5041)
16 Miyagi Children’s Hospital, Department of Hematology/Oncology, Sendai, Japan (GRID:grid.415988.9) (ISNI:0000 0004 0471 4457)
17 Saiseikai Nishiotaru Hospital, Otaru, Japan (GRID:grid.415988.9)
18 Kyoto University, Department of Clinical Application, Center for iPS Cell Research and Application (CiRA), Kyoto, Japan (GRID:grid.258799.8) (ISNI:0000 0004 0372 2033)
19 Okayama University, Department of Pediatrics, Okayama, Japan (GRID:grid.261356.5) (ISNI:0000 0001 1302 4472)
20 Osaka City General Hospital, Department of Pediatric Hematology/Oncology, Osaka, Japan (GRID:grid.416948.6) (ISNI:0000 0004 1764 9308)




