title: Advanced stage anaplastic large cell lymphoma in children and adolescents: results of ANHL0131, a randomized phase III trial of APO versus a modified regimen with vinblastine: a report from the children's oncology group.
abstract: BACKGROUND
  Optimal therapy for children and adolescents with advanced stage anaplastic large cell lymphoma (ALCL) is unknown. ANHL0131 examined whether a maintenance regimen including vinblastine compared to the standard APO (doxorubicin, prednisone, vincristine, methotrexate, 6-mercaptopurine) regimen would result in superior event-free survival.
  
  
  METHODS
  One hundred and twenty five eligible patients were enrolled. Induction was identical for both arms. Post induction patients were randomized to receive APO with vincristine every 3 weeks or a regimen that substituted vincristine with weekly vinblastine (APV).
  
  
  RESULTS
  There was no difference between the patients randomized to the APO versus APV arms in either event free survival (EFS) or overall survival (OS) (three year EFS 74% vs. 79%, P = 0.68 and three years OS of 84% vs. 86%, P = 0.87, respectively). Patients in the APV arm required dose reduction secondary to myelosuppression and had a higher incidence of neutropenia as well as infection with neutropenia compared to those in the APO arm (P < 0.001, P = 0.019, respectively).
  
  
  CONCLUSIONS
  Treatment with weekly vinblastine instead of every three week vincristine as part of multi-agent maintenance therapy did not result in improvement in EFS or OS. Weekly vinblastine was associated with increased toxicity. (ClinicalTrials.gov Identifier NCT00059839).
authors.affiliation: Division of Pediatric Hematology-Oncology, Hospital for Sick Children, Toronto, Ontario.
authors.forename: Sarah
authors.initials: S
authors.lastname: Alexander
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Kraveka
authors.forename: Sheila
authors.initials: S
authors.lastname: Weitzman
authors.forename: Eric
authors.initials: E
authors.lastname: Lowe
authors.forename: Lynette
authors.initials: L
authors.lastname: Smith
authors.forename: James C
authors.initials: JC
authors.lastname: Lynch
authors.forename: Myron
authors.initials: M
authors.lastname: Chang
authors.forename: Marsha C
authors.initials: MC
authors.lastname: Kinney
authors.forename: Sherrie L
authors.initials: SL
authors.lastname: Perkins
authors.forename: Joseph
authors.initials: J
authors.lastname: Laver
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gross
authors.forename: Howard
authors.initials: H
authors.lastname: Weinstein
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D017728:Lymphoma, Large-Cell, Anaplastic / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage; D008727:Methotrexate / Q000008:administration & dosage; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D014750:Vincristine; D014747:Vinblastine; D004317:Doxorubicin; D015122:Mercaptopurine; D011241:Prednisone; D008727:Methotrexate
keywords: anaplastic large cell lymphoma; vinblastine