title: Analysis of Japanese registration from the randomized international trial for childhood anaplastic large cell lymphoma (ALCL99-R1).
abstract: The randomized international trial for childhood anaplastic large cell lymphoma, (ALCL99-R1) involving European study groups and a Japanese group, compared six courses of methotrexate 1 g/m(2) over 24 hours with an intrathecal injection (IT) (MTX1 arm) with six courses of methotrexate 3 g/m(2) over 3 hours without IT (MTX3 arm). In this report, data from the Japanese portion of the trial are compared with the results of the international study. Overall, 352 patients were recruited for the international study, and 44 of these patients were from Japan. Median follow-up times were 3.8 and 3.5 years, respectively, in the international and Japanese studies. The two-year event-free and 2-year overall survival rates of the international study were 74% and 93%. The corresponding figures for those registered in Japan were 81% and 96%, respectively. Clinical characteristics and outcomes of patients were similar in the two groups. Incidences of grade 4 hematologic toxicity, infection, and grade 3 to 4 stomatitis, which were reported to be statistically significantly higher after the MTX1 arm in the international study, were also statistically significantly higher after the MTX1 arm for those registered in Japan. Results of ALCL99-R1 treatment in Japan were essentially the same as in the international study. The international study is anticipated to contribute to establishing an optimal treatment for ALCL, a rare childhood lymphoma.
authors.affiliation: Division of Leukemia and Lymphoma, Children's Cancer Center, National Center for Child Health and Development.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mori
authors.forename: Reiji
authors.initials: R
authors.lastname: Fukano
authors.forename: Akiko
authors.initials: A
authors.lastname: Saito
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Takimoto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sekimizu
authors.forename: Atsuko
authors.initials: A
authors.lastname: Nakazawa
authors.forename: Masahito
authors.initials: M
authors.lastname: Tsurusawa
authors.forename: Ryoji
authors.initials: R
authors.lastname: Kobayashi
authors.forename: Keizo
authors.initials: K
authors.lastname: Horibe
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007564:Japan; D017728:Lymphoma, Large-Cell, Anaplastic / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D012042:Registries; D015996:Survival Rate; D016896:Treatment Outcome