Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Purpose
The objective of this randomized trial was to assess the efficacy and safety of rituximab as in vivo
purging before transplantation and as maintenance treatment immediately after high-dose
chemotherapy and autologous stem-cell transplantation (HDC-ASCT) in patients with relapsed
follicular lymphoma (FL).
Patients and Methods
Patients with relapsed FL who achieved either complete or very good partial remission with
salvage chemotherapy were randomly assigned using a factorial design to rituximab purging (P;
375 mg/m2 once per week for 4 weeks) or observation (NP) before HDC-ASCT and to maintenance
rituximab (M; 375 mg/m2 once every 2 months for four infusions) or observation (NM).
Results
From October 1999 to April 2006, 280 patients were enrolled. The median age was 51 years
(range, 26 to 70 years), and baseline characteristics were well balanced between groups. On
average, patients were 44 months (range, 3 to 464 months) from diagnosis, with 79% having
received two lines and 15% three lines of prior therapy. Median follow-up was 8.3 years. In
contrast to purging, 10-year progression-free survival (PFS) was 48% for P and 42% for NP
groups (hazard ratio [HR], 0.80; 95% CI, 0.58 to 1.11; P .18); maintenance had a significant effect
on PFS (10-year PFS, 54% for M and 37% for NM; HR, 0.66; 95% CI, 0.47 to 0.91; P .012).
Overall survival (OS) was not improved by either rituximab purging or maintenance.
Conclusion
Rituximab maintenance after HDC-ASCT is safe and significantly prolongs PFS but not OS in
patients undergoing transplantation for relapsed FL. Pretransplantation rituximab in vivo purging,
even in rituximab-naive patients, failed to improve PFS or OS.

Keywords:lymphoma, autologous stem cell transplantation