In 2012 a randomized, open-label, phase III European Mantle Cell Lymphoma (MCL) Elderly trial, was published in which the efficacy and safety of R-CHOP treatment in elderly patients with mantle cell lymphoma (MCL) was compared to R-FC treatment. Recently this study was updated in order to establish the long-term effects of treatment with rituximab.
In total, 560 patients with newly diagnosed MCL either received treatment 1, consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), or treatment 2m consisting of rituximab, fludarabine, and cyclophosphamide (R-FC), A second random assignment in 316 responders between rituximab and interferon alfa maintenance followed, to be continued until progression. The update compared progression-free survival from the second randomization and overall survival from the first or second randomizations.
After a median follow-up time of 7.6 years, the previously described difference in OS between the induction arms persisted (median, 6.4 years after R-CHOP [n = 280] v 3.9 years after R-FC [n = 280]; P = .0054). Patients responding to R-CHOP had median progression-free survival and OS times of 5.4 and 9.8 years, respectively, when randomly assigned to rituximab (n = 87), compared with 1.9 years (P < .001) and 7.1 years (P = .0026), respectively, when randomly assigned to interferon alfa (n = 97).
After two years, in 58% of patients treated with R-CHOP, rituximab maintenance was still ongoing. And after five years the percentage was 32%. After R-FC, rituximab maintenance was associated with an unexpectedly high cumulative incidence of death in remission (22% at 5 years). Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%).
Summarizing, the positive results of R-CHOP followed by rituximab maintenance, as described in 2012, also persist over a longer period of time. Prolongation of rituximab maintenance beyond 2 years is effective and safe for elderly MCL patients.