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
Mené sur 280 patients atteints d'un lymphome folliculaire récidivant, cet essai prospectif randomisé évalue, du point de vue de la survie sans progression et de la survie globale, l'efficacité du rituximab en traitement d'entretien, après une chimiothérapie à haute dose et une greffe autologue de cellules souches, ou préalablemant à la greffe pour effectuer une purge in vivo des cellules souches
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.
Journal of Clinical Oncology , résumé, 2013