title: Phase II study of intensive post-remission chemotherapy and stem cell transplantation for adult acute lymphoblastic leukemia and lymphoblastic lymphoma: Japan Clinical Oncology Group Study, JCOG9402.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of intensive post-remission chemotherapy for untreated patients aged 15-69 years with adult acute lymphoblastic leukemia and lymphoblastic lymphoma in a multicenter Phase II study.
  
  
  METHODS
  The chemotherapy regimen consisted of induction, post-remission and maintenance for 2 years. The primary endpoint was 5-year progression-free survival, and secondary endpoints included complete remission rate, overall survival and adverse events. Among 115 patients enrolled, 108 eligible patients [median age, 33.5 years (range, 15-69)] including 96 acute lymphoblastic leukemia and 12 lymphoblastic lymphoma were assessed. Other major characteristics were male 50%, T-cell phenotype 21%, Philadelphia chromosome 22%, B-symptom+ 35% and performance status 2/3 22%.
  
  
  RESULTS
  Eighty-seven patients achieved complete remission (81%; 95% confidence interval 72-88%), while five (5%) died during the chemotherapy protocol. The median overall survival and progression-free survival were 1.8 years (95% confidence interval, 1.5-2.6) and 1.2 years (95% confidence interval, 0.8-1.6), respectively. Their 5-year overall survival and progression-free survival were 29 and 28%, respectively. The 5-year overall survival of 31 patients who underwent allogeneic (n = 19) or autologous (n = 12) stem cell transplantation during first complete response was 51%. Major non-hematologic toxicities of Grade 3 or greater were infections (21%) and pulmonary complications (6%). When compared with the investigators' previous Phase II trials, JCOG9402 improved progression-free survival and overall survival when compared with JCOG8702; however, it did not show improvement when compared with JCOG9004.
  
  
  CONCLUSIONS
  Although the intensified induction and post-remission chemotherapy was feasible and 28% of the patients with adult acute lymphoblastic leukemia or lymphoblastic lymphoma achieved long-term progression-free survival, JCOG9402 did not show improvement.
authors.affiliation: National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Teruhisa
authors.initials: T
authors.lastname: Azuma
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Takeyama
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Michihiro
authors.initials: M
authors.lastname: Hidaka
authors.forename: Mitsutoshi
authors.initials: M
authors.lastname: Kurosawa
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kasai
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Noriyasu
authors.initials: N
authors.lastname: Fukushima
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Mukai
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Tsukasaki
authors.forename: Masanori
authors.initials: M
authors.lastname: Shimoyama
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D012074:Remission Induction; D016019:Survival Analysis; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous; D017211:Treatment Failure; D016896:Treatment Outcome