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 performance 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
IntroductionFollicular lymphomas (FLs) are a subgroup of B-cell nonHodgkin lymphomas (NHLs) accounting for 15% to 30% of newly diagnosed lymphomas. [1][2][3] The natural history of this disease is characterized by a long survival that contrasts with systematic relapses. Many chemotherapy regimens have been used for treatment but have not improved long-term outcome, which depends on initial prognostic factors such as the Follicular Lymphoma International Prognostic Index (FLIPI), 4 response to first-line therapy, and minimal residual disease indicated by positivity of the bcl2 rearrangement on analysis of the polymerase chain reaction (PCR). Although new therapeutic approaches, including purine analogs and anti-CD20 monoclonal antibodies, have shown impressive response rates and prolonged progression-free survival (PFS), their effects on overall survival (OS) have yet to be confirmed. The major improvement in the management of FLs has been achieved by the use of the anti-CD20 monoclonal antibody rituximab, which improved OS in combination with chemotherapy in all 4 prospective, randomized studies published to date. [5][6][7][8][9] Before the era of monoclonal antibodies, autologous stem cell transplantation (ASCT) was evaluated as an alternative approach to standard chemotherapy. Numerous studies have shown encouraging results for patients with relapsed follicular NHL, [10][11][12][13] 10,15,16 The fourth study, from the Gruppo Italiano Trapianto di Midollo Osseo (GITMO), compared chemotherapy to ASCT with rituximab in both arms. 17 In 2005 we published the results of the Groupe Ouest-Est d'Etude des Leucémies et Autres Maladies du Sang (GOELAMS) 064 trial, showing a higher overall response rate and longer median event-free survival (EFS) in the high-dose therapy (HDT) group then the conventional chemotherapy group after a median follow-up of 5 years, with no difference in OS but a higher rate of secondary malignancies in the HDT group. 18 We report here the final results of this trial, after an extended follow-up period of 108 months (9 years...