title: Phase II study of chemotherapy and stem cell transplantation for adult acute lymphoblastic leukemia or lymphoblastic lymphoma: Japan Clinical Oncology Group Study 9004.
abstract: Granulocyte colony-stimulating factor (G-CSF)-supported, post-remission chemotherapy (Cx) for adult acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) was evaluated. One hundred and forty-three eligible patients (median age, 41 years) including 126 ALL and 17 LBL receiving induction Cx (vincristine, cyclophosphamide, prednisolone [PSL], doxorubicin, L-asparaginase, intrathecal-methotrexate [IT-MTX]) were analyzed. For patients achieving complete response (CR), two courses of post-remission Cx (course A of daunorubicin, cytosine arabinoside, vindesine, PSL plus IT-MTX; course B of mitoxantrone, etoposide, vincristine, PSL plus IT-MTX) with the use of G-CSF were repeated alternately; thereafter, maintenance Cx including MTX and 6-mercaptopurine was given for 2 years. One hundred and nineteen (83%) patients achieved CR, while 14 (10%) died during induction. Among the 119 patients achieving CR, five died in remission, 76 relapsed, and the remaining 38 were alive without disease. The median survival time of the 143 eligible patients was 26 months (95% confidence interval, 19-34). At a median follow-up time of 9 years, the 5-year survival rate was 32% and the 5-year progression-free survival (PFS) rate was 26%. The 5-year survival rate of 36 patients who underwent autologous (n = 20) or allogeneic stem cell transplantation (SCT; n = 16) in the first CR group was 58%. Compared with the authors' previous trials, survival and PFS were markedly improved. In conclusion, G-CSF-supported, intensive post-remission Cx and subsequent SCT are worthy of further investigation for the treatment of adult ALL and LBL.
authors.affiliation: National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. ktobinai@ncc.go.jp
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Takeyama
authors.forename: Fumito
authors.initials: F
authors.lastname: Arima
authors.forename: Keiko
authors.initials: K
authors.lastname: Aikawa
authors.forename: Tohru
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hanada
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kasai
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Eisaburo
authors.initials: E
authors.lastname: Sueoka
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mukai
authors.forename: Kinuko
authors.initials: K
authors.lastname: Tajima
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Shigeru
authors.initials: S
authors.lastname: Shirakawa
authors.forename: Tomomitsu
authors.initials: T
authors.lastname: Hotta
authors.forename: Shimoyama
authors.initials: S
authors.lastname: Masanori
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003561:Cytarabine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy / Q000628:therapy*; D033581:Stem Cell Transplantation; D014182:Transplantation, Autologous
chemical_list: D000964:Antimetabolites, Antineoplastic; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D008942:Mitoxantrone; D015122:Mercaptopurine; D008727:Methotrexate