Rituximab Maintenance for a Maximum of 5 Years After Single-Agent Rituximab Induction in XXXX : Results of the Randomized Controlled Phase III Trial SAKK 35/03.

@entity1 @entity137 @entity706 @entity1349
PURPOSE: Rituximab maintenance therapy has been shown to improve progression-free survival in @entity1 with @entity706 ; however, the optimal duration of maintenance treatment remains unknown. @entity1 AND METHODS: Two hundred seventy @entity1 with untreated, relapsed, stable, or chemotherapy-resistant @entity706 were treated with four doses of rituximab monotherapy in weekly intervals (375 mg/m(2)). @entity1 achieving at least a partial response were randomly assigned to receive maintenance therapy with one infusion of rituximab every 2 months, either on a short-term schedule (four administrations) or a long-term schedule (maximum of 5 years or until disease progression or unacceptable @entity137 ). The primary end point was event-free survival (EFS). Progression-free survival, @entity1349 ( @entity1349 ), and @entity137 were secondary end points. Comparisons between the two arms were performed using the log-rank test for survival end points. RESULTS: One hundred sixty-five @entity1 were randomly assigned to the short-term (n = 82) or long-term (n = 83) maintenance arms. Because of the low event rate, the final analysis was performed after 95 events had occurred, which was before the targeted event number of 99 had been reached. At a median follow-up period of 6.4 years, the median EFS was 3.4 years (95% CI, 2.1 to 5.3) in the short-term arm and 5.3 years (95% CI, 3.5 to not available) in the long-term arm (P = .14). @entity1 in the long-term arm experienced more adverse effects than did those in the short-term arm, with 76% v 50% of @entity1 with at least one adverse event (P < .001), five versus one @entity1 with grade 3 and 4 infections, and three versus zero @entity1 discontinuing treatment because of unacceptable @entity137 , respectively. There was no difference in @entity1349 between the two groups. CONCLUSION: Long-term rituximab maintenance therapy does not improve EFS, which was the primary end point of this trial, or @entity1349 , and was associated with increased @entity137 .
