Rituximab Maintenance Therapy After Autologous Stem-Cell Transplantation in Patients With Relapsed CD20+ Diffuse Large B-Cell Lymphoma: Final Analysis of the Collaborative Trial in Relapsed Aggressive Lymphoma.

Oct 2012

Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N,Shpilberg O, Dührsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Brière J, Salles G, Moskowitz CH, Glass B.

Source

Christian Gisselbrecht and Josette Brière, Hôpital Saint Louis, Paris; Nicolas Mounier, Centre Hospitalier Universitaire de l'Archet, Nice; Noel J. Milpied, Hôpital Haut-Lévêque, Pessac; Gilles Salles, Hospices Civils de Lyon and Université de Lyon, Lyon, France; Norbert Schmitz and Bertram Glass, Asklepios Klinik St Georg, Hamburg; Ulrich Dührsen, Universitätsklinikum Essen, Essen; Andreas Viardot, Universitätsklinik Ulm, Ulm, Germany; Devinder Singh Gill, Princess Alexandra Hospital, Woodville, South Australia; David D. Ma, St Vincent's Hospital Sydney, Darlinghurst, New South Wales; Ray Lowenthal, Royal Hobart Hospital, Tasmania, Australia; David C. Linch, University College London, Cancer Institute, London; John Radford, University of Manchester, Christie Hospital National Health Service Trust, Manchester, United Kingdom; Marek Trneny, Charles University General Hospital, Prague, Czech Republic; Andre Bosly, Université Catholique de Louvain Mont-Godinne, Yvoir, Belgium; Nicolas Ketterer, Clinique Bois-Cerf, Lausanne, Switzerland; Ofer Shpilberg, Davidoff Center, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel; Hans Hagberg, Akademiska Sjukhuset, Uppsala, Sweden; and Craig H. Moskowitz, Memorial Sloan-Kettering Cancer Center, New York, NY.

Abstract

PURPOSE

The standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL) is salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT). The impact of maintenance rituximab after ASCT is not known. 

PATIENTS AND METHODS

In total, 477 patients with CD20(+) DLBCL who were in their first relapse or refractory to initial therapy were randomly assigned to one of two salvage regimens. After three cycles of salvage chemotherapy, the responding patients received high-dose chemotherapy followed by ASCT. Then, 242 patients were randomly assigned to either rituximab every 2 months for 1 year or observation. 

RESULTS: 

46% v 56% for relapsed disease after 12 months), secondary age-adjusted International Prognostic Index (saaIPI) more than 1 - EFS: 37% v 61% for saaIPI , - and prior treatment with rituximab - EFS: 47% v 59% for no prior rituximab - . A significant difference in EFS between women at sixty three percent and men at forty six percent was also observed in the rituximab group. In the Cox model for maintenance, the saaIPI was a significant prognostic factor , as was male sex. 

CONCLUSION

In relapsed DLBCL, we observed no difference between the control group and the rituximab maintenance group and do not recommend rituximab after ASCT.

Full Text: Journal of Clinical Oncology