Single-Agent Rituximab as First-Line and Maintenance Treatment for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma: A Phase II Trial of the Minnie Pearl Cancer Research Network

Abstract

Single-agent rituximab, used at a standard dose and schedule, is active in the first-line treatment of patients with CLL/SLL, producing substantially higher response rates than previously reported in relapsed or refractory patients (51% v 13%, respectively). Re-treatment with rituximab at 6-month intervals is well tolerated. The PFS time of 18.6 months in patients with CLL/SLL seems shorter than the 36- to 40-month median PFSs previously reported with first-line plus maintenance rituximab in patients with follicular lymphoma. Additional follow-up is required to fully assess the impact of this treatment strategy.

Rituximab therapy in malignant lymphoma

“…In a European study in relapsing patients, the efficacy was low, with only a 10% RR (Foran et al, 2000). In untreated patients, in contrast, found a 51% RR after four injections, with only 4% CR, and a median PFS of 18 and 6 months Hainsworth et al (2003). Further studies are warranted to define the modality of use of rituximab monotherapy in this lymphoma, and its possible benefit.…”

“…A better activity has been observed in untreated patients (Hainsworth et al, 2003). Dose escalation, achieved by a thriceweekly dosing schedule (Byrd et al, 2001), or higher weekly doses, 500-2250 mg/m 2 (O'Brien et al, 2001), is necessary to reach significant clinical activity, with a RR of respectively 45 and 36%, as a single agent.…”

Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011

“…Rituximab also has single-agent activity in CLL. [7][8][9] Additionally, several large phase 2 studies combining rituximab with fludarabine 10,11 or the combination of fludarabine and cyclophosphamide 12 have demonstrated a much higher complete response rate than previously observed with any other therapeutic approaches used in CLL before this time. To date, comparative studies of rituximab and fludarabine combinations to fludarabine monotherapy have not been performed.…”

Changing paradigms in the treatment of chronic lymphocytic leukemia

“…27,28 Initial studies with rituximab monotherapy in previously treated patients with CLL and small lymphocytic lymphoma showed ORRs of 10-15%, [29][30][31][32] and although responses may be seen in up to 50% of untreated patients they are usually transient and CRs are rare. 33 The primary toxicities with rituximab are infusional reactions. Other side effects such as tumor lysis syndrome, reactivation of hepatitis, neutropenia, severe mucocutaneous reactions and progressive multifocal leukoencephalopathy are rare, but may be fatal.…”

“…Rituximab has been studied as a post-induction treatment. In one study, rituximab monotherapy was given as a consolidation therapy at 6 monthly intervals in those responding to or stable after initial front-line rituximab monotherapy for 4 weeks; 33 consolidation promoted additional responses, increasing the ORR and CR rate from 51 and 4%, respectively, after initial therapy to 58 and 9% after consolidation. The median PFS was 18.6 months at the time of reporting, with 1-year and 2-year PFS projected to be 62 and 49% respectively.…”