WEDNESDAY, Dec. 22 (HealthDay News) -- Patients with follicular lymphoma have significantly better progression-free survival if they undergo two years of rituximab maintenance therapy after immunochemotherapy, according to a study published online Dec. 21 in The Lancet.
In the PRIMA study, Gilles Salles, M.D., of Université Claude Bernard in Pierre-Bénite, France, and colleagues administered one of three non-randomized immunochemotherapy induction regimens to 1,217 patients with previously untreated follicular lymphoma needing systemic therapy. The investigators then randomized 1,019 patients achieving a complete or partial response to receive two years of rituximab maintenance therapy (375 mg/m² every eight weeks) or observation.
After a median follow-up of 36 months, the investigators found that progression-free survival was significantly improved with rituximab maintenance therapy compared to observation (74.9 versus 57.6 percent). Two years post-randomization, 71.5 percent of patients in the rituximab maintenance group were in complete or unconfirmed complete response compared to 52.2 percent in the observation group. Overall survival did not differ significantly between the rituximab maintenance therapy group and the observation group. The investigators also found that grades 3 and 4 adverse events were recorded in 24 percent of patients in the rituximab maintenance group and 17 percent in the observation group.
"Results of the PRIMA study show that two years of rituximab maintenance therapy significantly prolongs progression-free survival, delays the time to next antilymphoma treatment and next chemotherapy, and improves the quality of response in patients with previously untreated follicular intensity of the first-line induction therapy and the response achieved," the authors write.
The study was funded in part by F. Hoffmann-La Roche; several authors disclosed financial ties to F. Hoffmann-La Roche and other pharmaceutical companies.
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