ATLANTA—Concomitant administration of rituximab (Rituxan) and chemotherapy with cyclophosphamide, vincristine, and prednisone (CVP) appears effective in patients with stage III-IV follicular non-Hodgkin's lymphoma (NHL), Philippe Solal-Cligny, MD, PhD, of the Jean Bernard Cancer Center, Le Mans, France, said at the 47th Annual Meeting of the American Society of Hematology (ASH abstract 350).
Dr. Solal-Cligny explained that "several randomized studies showed that a combination of rituximab plus chemotherapy significantly improved progression-free survival in patients with follicular lymphoma whose disease required initial treatment. However, there is no consensus on the optimal chemotherapy to give to these patients."
At ASH, Dr. Solal-Cligny and his colleagues presented updated efficacy results, with median follow-up of 42 months, of their phase III multicenter, international trial evaluating CVP plus rituximab as initial treatment for patients with CD20-positive, stage III-IV follicular NHL who had received no prior systemic therapy. They previously reported 30-month results in Blood (105:1417-1423, 2005).
Patients were randomized to receive CVP (n = 159) or rituximab plus CVP (R-CVP) (n = 162) for a total of four 3-week cycles, at which point patients were restaged. Those achieving at least a partial response were continued on the same regimen for four additional cycles. Almost half of all patients had a poor-prognosis Follicular Lymphoma International Prognostic Index (FLIPI) score of 3 to 5.
The R-CVP regimen was significantly superior to CVP in terms of overall response rate (80.9% vs 56.6%, P < .0001) and proportion of patients achieving complete response (CR) or unconfirmed CR (40.7% vs 10%, P < .0001). The addition of rituximab also increased the durability of responses (median 38 months vs 13.5 months, P < .0001).
The median time to treatment failure was significantly longer with R-CVP vs CVP (27.0 vs 6.6 months, P < .0001), he reported, as were the median time to progression, relapse, or death (34 vs 14.5 months, P < .0001), and median disease-free survival (45 months vs 20.5 months, P = .0006). Although at 42 months median follow-up, the median overall survival had not been reached for either arm, the investigators observed a trend toward improved overall survival with the addition of rituximab (P = .0553).
A safety analysis showed an increased frequency in grade 3-4 adverse events in the combination arm: 34% of R-CVP patients had at least one grade 3-4 adverse event vs 19.5% with CVP. This was primarily due to an increased frequency of grade 3-4 neutropenia with R-CVP vs CVP (24% vs 14.5%). Dr. Solal-Cligny pointed out, however, that there was no increased incidence of febrile neutropenia, which was low in both arms.