title: Effective VCR/DEX pulse maintenance therapy in the KYCCSG ALL-02 protocol for pediatric acute lymphoblastic leukemia.
abstract: In a previous study of childhood acute lymphoblastic leukemia (ALL) by the Kyushu-Yamaguchi Children's Cancer Study Group, ALL-96, we achieved a 72.1 % 5-year event-free survival (EFS) and an 84.8 % 5-year overall survival (OS). In a subsequent study, ALL-02, we adopted a vincristine dexamethasone (VCR/DEX) pulse regimen as maintenance therapy in the context of the ALL-96 study using the same risk classification and treatment schedule. A total of 156 pediatric cases of ALL were treated with ALL-02. All of the patients were classified as standard-risk or high-risk. Risk stratification was based on white cell counts, immunophenotype, the presence of central nervous system (CNS) disease at diagnosis, organomegaly, and early treatment response (day 14 bone marrow status). The 7-year EFS and OS rates were 77.7 % (95 % CI 70.6-84.8 %) and 89.5 % (95 % CI 84.6-94.4 %), respectively. CNS 3 status [hazard ratio (HR) = 5.0, p = 0.009] and high white blood cell count at diagnosis (HR = 2.6, p = 0.047) were risk factors for poor EFS in multivariate analysis. Our strategies to categorize patients into two risk groups, and to treat with a VCR/DEX pulse were feasible and reasonably effective treatments for pediatric ALL.
authors.affiliation: Department of Pediatrics, Kagoshima University Hospital, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan. okamoto@m2.kufm.kagoshima-u.ac.jp.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Okamoto
authors.affiliation: Department of Pediatrics, Kyushu University, Fukuoka, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Koga
authors.affiliation: Department of Pediatrics, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Jiro
authors.initials: J
authors.lastname: Inagaki
authors.affiliation: Department of Pediatrics, Kurume University, Kurume, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ozono
authors.affiliation: Department of Pediatrics, Kurume University, Kurume, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Ueda
authors.affiliation: Department of Pediatrics, Yamaguchi University, Yamaguchi, Japan.
authors.forename: Maiko
authors.initials: M
authors.lastname: Shimoura
authors.affiliation: Department of Pediatrics, Ohita Prefectural Hospital, Ohita, Japan.
authors.forename: Nobuyoshi
authors.initials: N
authors.lastname: Itonaga
authors.affiliation: Department of Pediatrics, Kagoshima City Hospital, Kagoshima, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Shinkoda
authors.affiliation: Division of Pediatrics, University of Miyazaki, Miyazaki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Moritake
authors.affiliation: Department of Pediatrics, Fukuoka University, Fukuoka, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Nomura
authors.affiliation: Department of Pediatrics, Fukuoka Higashi Medical Center, Fukuoka, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Nakayama
authors.affiliation: Department of Pediatrics, Tokuyama City Hospital, Shunan, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Hotta
authors.affiliation: Department of Pediatrics, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
authors.forename: Yasufumi
authors.initials: Y
authors.lastname: Hidaka
authors.affiliation: Department of Pediatrics, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan.
authors.forename: Hidemi
authors.initials: H
authors.lastname: Shimonodan
authors.affiliation: Department of Pediatrics, Beppu Medical Center, Beppu, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Suga
authors.affiliation: Department of Pediatrics, Kagoshima University Hospital, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Tanabe
authors.affiliation: Department of Pediatrics, Kyushu University, Fukuoka, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Nakashima
authors.affiliation: Department of Pediatrics, National Kyushu Cancer Center, Fukuoka, Japan.
authors.forename: Reiji
authors.initials: R
authors.lastname: Fukano
authors.affiliation: Department of Pediatrics, Kagoshima University Hospital, 8-35-1 Sakuragaoka, Kagoshima, 890-8520, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Kawano
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007223:Infant; D007958:Leukocyte Count; D060046:Maintenance Chemotherapy; D008297:Male; D015999:Multivariate Analysis; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000145:classification / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D012306:Risk; D012307:Risk Factors; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D003907:Dexamethasone
keywords: Maintenance therapy; Pediatric acute lymphoblastic leukemia; VCR and DEX pulse