Myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission prolongs progression-free survival in follicular lymphoma: results of a prospective, randomized trial of the German Low-Grade Lymphoma Study Group

Abstract

Conventional chemotherapy has failed to substantially prolong survival for patients with advanced follicular lymphoma. To improve outcomes, the German LowGrade Lymphoma Study Group (GLSG) initiated a randomized trial to compare the effect of potentially curative myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) with interferon-␣ (IFN-␣) maintenance therapy in first remission. Three hundred seven patients (younger than 60 years) with follicular lymphoma were recruited into the trial from 130 institutions. After 2 cycles of cyclophosphamide-doxorubicinvincristine-prednisone (CHOP) or mitoxantrone-chlorambucil-prednisone (MCP) induction chemotherapy, patients were randomly assigned to either the ASCT or the IFN-␣ group. The respective therapy was started when patients achieved complete or partial remission after induction chemotherapy. Two hundred forty patients with follicular lymphoma are evaluable for the comparison of ASCT and IFN-␣. In patients who underwent ASCT, the 5-year progression-free survival (PFS) rate was 64.7%, and in the IFN-␣ arm it was 33.3% (P < .0001). As expected, acute toxicity was higher in the ASCT group, but early mortality was below 2.5% in both study arms. In this randomized, multicenter trial, high-dose radiochemotherapy followed by ASCT significantly improved PFS compared with IFN-␣ in patients with follicular lymphoma when applied as consolidation in first remission. Longer follow-up is necessary to determine the effect of ASCT on overall

The outcome of reduced intensity allogeneic stem cell transplantation and autologous stem cell transplantation when performed as a first transplant strategy in relapsed follicular lymphoma: an analysis from the Lymphoma Working Party of the EBMT

“…We have only included patients undergoing transplantation beyond first response, as this is the currently accepted indication for transplantation in FL. [18][19][20] A prospective study comparing auto-SCT with RIST in this setting unfortunately failed due to poor accrual, 16 and further prospective comparative studies in this setting are unlikely to be performed. Therefore, retrospective studies describing these two forms of transplant provide an important source of data.…”

“…[11][12][13][14][15] By contrast, auto-SCT is associated with a low early NRM of o5%. 2,3,[18][19][20] Late toxicities must also be taken into consideration when selecting a transplant strategy. Thus following an auto-SCT the development of secondary MDS (myelodysplastic syndrome)/AML has been reported in up to 10% of patients at 10 years post transplant.…”

Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009

“…Patients with FL are normally not considered candidates for an autologous HSCT as first-line therapy, although three phase III prospective clinical trials [47][48][49] performed before the 'rituximab era' suggested a role in some subgroups of high-risk patients. Autologous HSCT remains the standard approach for early relapsing patients with FL.…”

Autologous stem cell transplantation beyond 60 years of age

“…Most of the randomized trials of NHL including an ASCT arm have accepted only patients less than 60 years of age, [9][10][11][12] although patients up to 65 years have been included in more recent trials. 13,14 In MM, the upper age limit in randomized trials has shifted from 60 15,16 to 65 years.…”