High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years

Blood. 2009 Jan 29;113(5):995-1001. doi: 10.1182/blood-2008-05-160200. Epub 2008 Oct 27.

Abstract

Autologous stem cell transplantation (ASCT) as first-line therapy for follicular lymphoma (FL) remains controversial. The multicenter study randomized 172 patients with untreated FL for either immunochemotherapy or high-dose therapy (HDT) followed by purged ASCT. Conditioning was performed with total body irradiation (TBI) and cyclophosphamide. The 9-year overall survival (OS) was similar in the HDT and conventional chemotherapy groups (76% and 80%, respectively). The 9-year progression-free survival (PFS) was higher in the ASCT than the chemotherapy group (64% vs 39%; P = .004). A PFS plateau was observed in the HDT group after 7 years. On multivariate analysis, OS and PFS were independently affected by the per-formance status score, the number of nodal areas involved, and the treatment group. Secondary malignancies were more frequent in the HDT than in the chemotherapy group (6 secondary myelodysplastic syndrome/acute myeloid leukemia and 6 second solid tumor cancers vs 1 acute myeloid leukemia, P = .01). The occurrence of a PFS plateau suggests that a subgroup of patients might have their FL cured by ASCT. However, the increased rate of secondary malignancies may discourage the use of purged ASCT in combination with TBI as first-line treatment for FL. This trial has been registered with ClinicalTrials.gov under identifier NCT00696735.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Bone Marrow Purging*
  • Cyclophosphamide / administration & dosage
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Immunotherapy / methods
  • Lymphoma, Follicular / mortality*
  • Lymphoma, Follicular / therapy*
  • Male
  • Middle Aged
  • Myeloablative Agonists / administration & dosage
  • Neoplasms, Second Primary / mortality*
  • Stem Cell Transplantation*
  • Survival Rate
  • Transplantation Conditioning*
  • Transplantation, Autologous
  • Whole-Body Irradiation

Substances

  • Myeloablative Agonists
  • Cyclophosphamide

Associated data

  • ClinicalTrials.gov/NCT00696735