Among patients with follicular lymphoma who responded to initial treatment with chemotherapy and RituxanÂ® (rituximab), those who received an additional two years of Rituxan as maintenance therapy remained free of lymphoma progression for longer than patients who did not receive maintenance therapy. These results were published in the The Lancet.
Rituxan is a targeted therapy that binds to a marker known as CD20 on the surface of B-cells. This binding prompts the immune system to destroy the cell, and may also have direct anticancer effects on the cell. Rituxan is commonly used in the treatment of non-Hodgkinâs lymphoma, and more recent studies have shown that itâs also active against chronic lymphocytic leukemia.
Maintenance therapy refers to longer-term treatment that is given after patients achieve remission with standard therapy. The goal of maintenance therapy is to prolong remission.
Rituxan maintenance therapy was evaluated in a Phase III clinical trial known as PRIMA. The study enrolled primarily patients with Stage III or IV follicular lymphoma whose disease had been reduced or eliminated by initial treatment with a combination of chemotherapy and Rituxan. Half the study participants were assigned to receive an additional two years of Rituxan as maintenance therapy, and half received no maintenance therapy.
Patients have now been followed for a median of three years.
- Three-year progression-free survival was 74.9% among patients given Rituxan maintenance therapy compared with 57.6% of patients given no maintenance therapy.
- Overall survival did not differ significantly between the two groups.
- Patients in the Rituxan maintenance group were more likely to experience infections (39% versus 24% in the no-maintenance group).
- Quality of life was similar in the two study groups.
These results suggest that maintenance therapy with Rituxan prolongs remission among patients with follicular lymphoma.
An accompanying editorial notes that some questions remain about the long-term risks and benefits of Rituxan maintenance therapy. The editorial concludes: âUntil these questions are answered, to state that maintenance is needed for all patients with follicular lymphoma who are initially treated with rituximab plus chemotherapy seems premature. However, maintenance is an option and the PRIMA investigators are to be congratulated for this important contribution, and are strongly encouraged to continue follow-up of these patients to answer the questions that remain.â
Salles G, Seymour JF, Offner F et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. The Lancet [early online publication]. December 21, 2010.
Friedberg JW. Rituximab maintenance in follicular lymphoma: PRIMA. The Lancet [early online publication]. December 21, 2010.
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