The Phase III international PRIMA trial has found that two years of rituximab (Rituxan) "maintenance" therapy reduced the risk of follicular lymphoma recurrence by 50 percent in patients who responded to initial chemotherapy. Maintenance therapy is longer-term treatment given after patients achieve remission with standard therapy, with the goal of prolonging remission.

"These findings provide hope for the way we manage this disease. Rituximab maintenance therapy is likely to become a new standard of care for these patients," said lead author Gilles Salles, MD, professor of medicine at the University of Lyon. He noted that most patients with this type of lymphoma are at risk for a relapse within three to six years of their initial therapy.

In this study, patients with primarily stage III or IV follicular lymphoma whose disease was reduced or eliminated by rituximab-based combination chemotherapy (induction therapy) were randomly assigned to receive two additional years of rituximab as maintenance therapy (505 patients) or no maintenance therapy (observation group, 513 patients).

After a median follow-up time of 25 months, disease progression occurred in 18 percent of the rituximab group compared with 34 percent of the observation group. The benefits of rituximab maintenance were observed regardless of patients' stage of remission, age, or prior treatment regimen. The researchers noted that longer follow-up of the patients is needed to confirm the benefits of maintenance rituximab therapy for reducing the risk of lymphoma relapse.

Rituximab maintenance therapy was well tolerated, with the most common side effects being infections (37 percent for the rituximab group compared with 22 percent of the observation group). Quality of life was similar between the two groups.

Based on these data, the manufacturer of rituximab has applied for approval in the United States and Europe for an expanded indication for rituximab as maintenance therapy in these patients.


Source: ASCO 2010: 

Abstract ID: 8004

Rituximab maintenance for 2 years in patients with untreated high tumor burden follicular lymphoma after response to immunochemotherapy.

Authors: G. A. Salles, J. F. Seymour, P. Feugier, F. Offner, A. Lopez-Guillermo, R. Bouabdallah, L. M. Pedersen, P. Brice, D. Belada, L. Xerri