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Clinical Trial
. 2014 Dec;61(12):2236-42.
doi: 10.1002/pbc.25187. Epub 2014 Aug 23.

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

Sarah Alexander  1 , 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
Affiliations
Clinical Trial

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

Sarah Alexander et al. Pediatr Blood Cancer. 2014 Dec.

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).

Keywords: anaplastic large cell lymphoma; vinblastine.

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Figures

Figure 1
Figure 1
Chemotherapy schema
Figure 2
Figure 2
Event free (a) and overall survival (b) by treatment arm
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Figure 3
Figure 4
Figure 4
Event free (a) and overall survival (b) by histologic subtype
See this image and copyright information in PMC

References

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