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.

PROCEDURE:

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: Sarah Alexander, Jacqueline M Kraveka, Sheila Weitzman, Eric Lowe, Lynette Smith, James C Lynch, Myron Chang, Marsha C Kinney, Sherrie L Perkins, Joseph Laver, Thomas G Gross, Howard Weinstein
• Journal: Pediatric blood & cancer (Pediatr Blood Cancer) Vol. 61 Issue 12 Pg. 2236-42 (Dec 2014) ISSN: 1545-5017 [Electronic] United States
• PMID: 25156886 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2014 Wiley Periodicals, Inc.

Chemical References

• Vincristine
• Vinblastine
• Doxorubicin
• Mercaptopurine
• Prednisone
• Methotrexate

Topics

• Adolescent
• Adult
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Child
• Child, Preschool
• Doxorubicin (administration & dosage)
• Female
• Follow-Up Studies
• Humans
• Infant
• Lymphoma, Large-Cell, Anaplastic (drug therapy, mortality, pathology)
• Male
• Mercaptopurine (administration & dosage)
• Methotrexate (administration & dosage)
• Neoplasm Staging
• Prednisone (administration & dosage)
• Prognosis
• Survival Rate
• Vinblastine (administration & dosage)
• Vincristine (administration & dosage)
• Young Adult