Phase II study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group Study (E1405).

Blood (Impact Factor: 10.45). 01/2014; 123(11). DOI: 10.1182/blood-2013-08-523845
Source: PubMed


VcR-CVAD (rituximab, bortezomib, modified hyper-CVAD) induction chemoimmunotherapy and maintenance rituximab (MR) was evaluated for efficacy and safety in ECOG protocol E1405. Patients with previously untreated mantle cell lymphoma (MCL) received VcR-CVAD chemotherapy every 21 days for 6 cycles, followed by MR for 2 years. Transplant eligible patients had the option of autologous stem cell transplantation (ASCT) consolidation instead of MR. The primary end point was the complete response (CR) rate to VcR-CVAD. The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicities. Seventy-five eligible patients with a median age of 62 (range 40-76) were enrolled. The ORR was 95% and a CR was achieved in 68% of patients. After a median follow-up of 4.5 years, 3-year PFS and OS were 72% and 88%, respectively. No substantial difference in PFS or OS was observed between patients treated with MR (n=44) versus ASCT (n=22). There were no unexpected toxicities. VcR-CVAD produced high ORR and CR rates in MCL. MR after VcR-CVAD induction performed similarly to ASCT and may improve response duration. Randomized clinical trials (RCTs) comparing MR against ASCT should be considered and RCTs evaluating bortezomib's contribution to conventional therapy are underway. This study was registered with (identifier NCT00433537).

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