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Blood, 29 January 2009, Vol. 113, No. 5, pp. 995-1001. Prepublished online as a Blood First Edition Paper on October 27, 2008; DOI 10.1182/blood-2008-05-160200.
CLINICAL TRIALS AND OBSERVATIONS 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 years1 Department of Hematology, Bretonneau University Hospital, Tours; 2 Department of Hematology, University Hospital, Angers; 3 Department of Biostatistics, Faculty of Medicine, Tours; 4 Department of Pathology, Centre Hospitalier, Orléans; 5 Department of Hematology, University Hospital of Nantes, Nantes; 6 Department of Hematology, University Hospital, Brest; 7 Department of Hematology, Centre Hospitalier, La Roche-sur-Yon; 8 Department of Hematology, University Hospital of Poitiers, Jean Bernard Hospital, Poitiers; 9 Department of Hematology, University Hospital, Grenoble; 10 Department of Hematology, University Hospital of Montpellier, Montpellier; 11 François Baclesse Anticancer Center, Caen; 12 Department of Hematology, University Hospital, Amiens; 13 Department of Hematology, University Hospital, Saint-Etienne; 14 Department of Hematology, Catherine de Sienne Clinic, Nantes; 15 Department of Hematology, Georges Pompidou European Hospital, Paris; 16 Antoine Lacassagne Anticancer Center, Nice; 17 Department of Hematology, University Hospital, Clermont-Ferrand; 18 Department of Hematology, University Hospital of Bordeaux, Bordeaux; and 19 Inserm, U645, Franche-Comté University and Department of Hematology, Jean Minjoz Hospital, Besançon, France 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 [ClinicalTrials.gov] .
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