title: Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: a phase II study by the Japan Adult Leukemia Study Group.
abstract: The superiority of the pediatric protocol for adolescents with acute lymphoblastic leukemia (ALL) has already been demonstrated, however, its efficacy in young adults remains unclear. The ALL202-U protocol was conducted to examine the efficacy and feasibility of a pediatric protocol in adolescents and young adults (AYAs) with BCR-ABL-negative ALL. Patients aged 15-24 years (n=139) were treated with the same protocol used for pediatric B-ALL. The primary objective of this study was to assess the disease-free survival (DFS) rate and its secondary aims were to assess toxicity, the complete remission (CR) rate and the overall survival (OS) rate. The CR rate was 94%. The 5-year DFS and OS rates were 67% (95% confidence interval (CI) 58-75%) and 73% (95% CI 64-80%), respectively. Severe adverse events were observed at a frequency that was similar to or lower than that in children treated with the same protocol. Only insufficient maintenance therapy significantly worsened the DFS (hazard ratio 5.60, P<0.001). These results indicate that this protocol may be a feasible and highly effective treatment for AYA with BCR-ABL-negative ALL.
authors.affiliation: Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: F
authors.initials: F
authors.lastname: Hayakawa
authors.affiliation: Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Sakura
authors.affiliation: Third Department of Internal Medicine, Yamaguchi University School of Medicine, Ube, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Yujiri
authors.affiliation: Department of General Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Kondo
authors.affiliation: Department of Hematology/Immunology, Fujisawa City Hospital, Fujisawa, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Fujimaki
authors.affiliation: Department of Internal Medicine, Miyagi Cancer Center, Natori, Japan.
authors.forename: O
authors.initials: O
authors.lastname: Sasaki
authors.affiliation: Department of Hematology and Rheumatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Miyatake
authors.affiliation: Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine, Maebashi, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Handa
authors.affiliation: Department of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ueda
authors.affiliation: Department of Internal Medicine, Seichoukai Fuchu Hospital, Izumi, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Aoyama
authors.affiliation: Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Takada
authors.affiliation: Third Department of Internal Medicine, Yamaguchi University School of Medicine, Ube, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: The Jikei University School of Medicine, Tokyo, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Usui
authors.affiliation: Division of Hematology, Tokyo Metropolitan Otsuka Hospital, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Miyawaki
authors.affiliation: Department of Pediatrics and Child Neurology, Oita University Faculty of Medicine, Oita, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Suenobu
authors.affiliation: Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Horibe
authors.affiliation: Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Kiyoi
authors.affiliation: Oncology Center, Hamamatsu University School of Medicine, Hamamatsu, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ohnishi
authors.affiliation: Department of Hematology and Molecular Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Department of Clinical Laboratory Science, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Ohtake
authors.affiliation: Department of Hematology and Oncology, National Cancer Center Hospital, National Cancer Center, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Kobayashi
authors.affiliation: Department of Preventive Medicine, Kyushu University Faculty of Medical Sciences, Fukuoka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Matsuo
authors.affiliation: National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Naoe
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality*; D011446:Prospective Studies; D012074:Remission Induction; D015996:Survival Rate; D055815:Young Adult