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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.
AuthorsKensei Tobinai, Kunihiko Takeyama, Fumito Arima, Keiko Aikawa, Tohru Kobayashi, Shuichi Hanada, Masaharu Kasai, Michinori Ogura, Eisaburo Sueoka, Kiyoshi Mukai, Kinuko Tajima, Haruhiko Fukuda, Shigeru Shirakawa, Tomomitsu Hotta, Shimoyama Masanori, Lymphoma Study Group of the Japan Clinical Oncology Group
JournalCancer science (Cancer Sci) Vol. 98 Issue 9 Pg. 1350-7 (Sep 2007) ISSN: 1347-9032 [Print] England
PMID17640299 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Antimetabolites, Antineoplastic
  • Cytarabine
  • Granulocyte Colony-Stimulating Factor
  • Etoposide
  • Mitoxantrone
  • Mercaptopurine
  • Methotrexate
Topics
  • Adolescent
  • Adult
  • Aged
  • Antimetabolites, Antineoplastic (administration & dosage)
  • Combined Modality Therapy
  • Cytarabine (administration & dosage)
  • Etoposide (administration & dosage)
  • Female
  • Granulocyte Colony-Stimulating Factor (administration & dosage)
  • Humans
  • Male
  • Mercaptopurine (administration & dosage)
  • Methotrexate (administration & dosage)
  • Middle Aged
  • Mitoxantrone (administration & dosage)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy, therapy)
  • Stem Cell Transplantation
  • Transplantation, Autologous

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