Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA
Olivier Fitoussi, Karim Belhadj, Nicolas Mounier, Marie Parrens, Hervé Tilly, Gilles Salles, Pierre Feugier, Christophe Ferme, Loic Ysebaert, Jean Gabarre, Raoul Herbrecht, Maud Janvier, Eric Van Den Neste, Franck Morschhauser, Olivier Casasnovas, Hervé Ghesquieres, Bruno Anglaret, Sabine Brechignac, Corinne Haioun, Christian Gisselbrecht, Olivier Fitoussi, Karim Belhadj, Nicolas Mounier, Marie Parrens, Hervé Tilly, Gilles Salles, Pierre Feugier, Christophe Ferme, Loic Ysebaert, Jean Gabarre, Raoul Herbrecht, Maud Janvier, Eric Van Den Neste, Franck Morschhauser, Olivier Casasnovas, Hervé Ghesquieres, Bruno Anglaret, Sabine Brechignac, Corinne Haioun, Christian Gisselbrecht
Abstract
Background: As rituximab combined with CHOP improves complete remission and overall survival in diffuse large B-cell lymphoma, intensified chemotherapy followed by autologous stem-cell transplantation has also been advocated for high-risk patients. The aim of this study was to establish whether or not combining rituximab with high-dose chemotherapy and auto-transplantation also benefits patient survival.
Design and methods: The LNH2003-3 study was a phase II trial including diffuse large B-cell lymphoma patients with 2 or 3 International Prognostic Index factors. They received four cycles of intensive biweekly chemotherapy with rituximab, doxorubicine, cyclophosphamide, vindesine, bleomycine, prednisolone (R-ACVBP) followed by auto-transplantation in responding patients. Two hundred and nine patients under 60 years of age were included in the study and 155 responding patients underwent auto-transplantation. In addition, a case-control study was performed by matching (1:1) 181 patients treated with R-ACVBP with ACVBP patients not given rituximab but submitted to auto-transplantation from the previous LNH1998-3 trial.
Results: With a median follow up of 45 months, 4-year progression-free survival and overall survival were estimated at 76% (CI: 69-81) and 78% (CI: 72-83), respectively. There was no difference between patients with 2 or 3 International Prognostic Index factors. Four year progression-free survival was significantly higher in R-ACVBP than ACVBP patients (74% vs. 58%; P=0.0005). There was also a significant increase in 4-year overall survival (76% vs. 68%; P=0.0494).
Conclusions: In high-risk diffuse large B-cell lymphoma patients, treatment with R-ACVBP followed by auto-transplantation results in a 78% 4-year overall survival which should be compared to other approaches.
Trial registration: ClinicalTrials.gov NCT00144807.
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Source: PubMed