Busulfan, Melphalan, and Etoposide (Bume) Showed an Equivalent Effect to Busulfan, Cyclophosphamide, and Etoposide (BuCE) as Conditioning Therapy for Autologous Stem Cell Transplantation in Patients with Relapsed or High Risk Non-Hodgkin's Lymphoma: A Multicenter Randomized Phase II Study by the Consortium for Improving Survival of Lymphoma (CISL)

Abstract

Purpose: High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard management for relapsed or high-risk non-Hodgkin’s lymphoma (NHL). We reported the busulfan/melphalan/etoposide (BuME) conditioning regimen was effective in patients with relapsed or high-risk NHL. Moreover, the busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been used widely in ASCT for NHL. Therefore, based on these encouraging results, this randomized phase II multicenter trial compared the outcomes of BuME and BuCE as conditioning therapies for ASCT in patients with NHL.

Materials and Methods: Patients were randomly assigned to receive either BuME (n=36) or BuCE (n=39). The BuME regimen was comprised of busulfan (3.2 mg/kg/day, intravenous [i.v.]) administered on Days -7, -6, and -5, etoposide (400 mg/m2 i.v.) on Days -5 and -4, and melphalan (50 mg/m2/day i.v.) on Days- 3 and -2. The BuCE regimen was comprised of busulfan (3.2 mg/kg/day i.v.) on Days -7, -6, and -5, etoposide (400 mg/m2/day i.v.) on Days -5 and -4, and cyclophosphamide (50 mg/kg/day i.v.) on Days -3 and -2. The primary endpoint was 2-year progression-free survival (PFS).

Results: Seventy-five patients were enrolled. Eleven (30.5%) patients in the BuME group and 13 (33.3%) patients in the BuCE group had disease progression or died. The 2-year PFS rate was 65.4% in the BuME group and 60.6% in the BuCE group (p=0.75). There were no non-relapse mortalities within 100 days after transplantation.

Conclusion: There were no significant differences in PFS between the two groups. Therefore, busulfan-based conditioning regimens, BuME and BuCE, may be important treatment substitutes for the BCNU-containing regimens.