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Rituximab vs nothing after high-dose consolidative first-line chemotherapy with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma Results of the first interim analysis of the randomized LNH98-B3 GELA Study



Rituximab vs nothing after high-dose consolidative first-line chemotherapy with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma Results of the first interim analysis of the randomized LNH98-B3 GELA Study



Blood 102(11): 399a



In the LNH87-2 study we have shown that consolidative HDC provides a better disease-free survival and survival for patients (pts) with aggressive non-Hodgkin's lymphoma presenting with 2 or 3 adverse age-adjusted International-Prognostic-Index (aa-IPI) factors, if they first reach complete remission after induction treatment (Haioun JCO 2000). In the mean time, ritaximab had been evaluated as a single therapeutic agent in aggressive lymphomas with promising efficacy (Coiffier Blood 1998). The primary objective of the present study was to evaluate the potential benefit, as randomly compared to "nothing", of rituximab -375mg/m2/week for 4 weeks -2 months after HDC, in decreasing the relapse rate (second randomization:R2). A secondary objective was to improve the response rate before HDC treatment using the intensified "ACE" chemotherapy regimen (doxorubicin 75mg/m2 d1, cyclophosphamide 1g/m2 d1-d2, etoposide 150mg/m2 d1-d3) as compared to the standard GELA "ACVBP" induction regimen (first randomization:R1). Induction regimens were delivered every 15 days for 4 cycles with G-CSF support. In responding pts, peripheral blood stem cell (PBSC) collection was performed after the third or fourth cycle. HDC (mitoxantrone 45 mg/m2, cyclophosphamide 1500 mg/m2X4d, etoposide 250 mg/m2X4d and carmustine 300 mg/m2) followed by PBSC was started between d80 and d90 after one or two courses of high-dose methotrexate. From 10/99 to 05/03 (closing date), 479 pts younger than 60 years with diffuse large B-cell lymphoma and aa-IPI 2 or 3 were enrolled. We here present the results of the first interim analysis, performed in February 2003, on 297 patients (aa-IPI 3:29%) who underwent randomization (R1) before October 1, 2001. This analysis has been validated by an independent expert committee. 151 pts were assigned to receive ACE and 146 to ACVBP. Complete response (CR+CRu) rates to induction treatment did not significantly differ between the two regimens (69% and 64%, respectively, p=0.37) and toxic death rates were similar (2% and 3%, respectively) despite higher NCIC grade 3-4 infectious toxicity with the ACE regimen. Among the 211 pts who received HDC, 170 were randomized (R2) after hematological recovery to receive either rituximab (n=90) or nothing (n=80). The major reasons for randomization not performed were protocol violation or early progression. 353 infusions of rituximab were administered with no clinically relevant infectious toxicity except two resolutive varicella-zoster virus infections. With a median follow-up of 13 months after R2, the 2y-event free survival did not yet significantly differ between the two groups (rituximab: 80% vs nothing: 70%, p=0.15). A longer follow-up will determine whether rituximab delivered as a post HDC treatment will improve outcome. Moreover the intensified "ACE" induction regimen did not provide a significant improvement of the response rate leading the GELA to now evaluate rituximab combined to ACVBP as induction treatment of such high risk pts.

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