Long-term follow-up of the randomized, open label, phase 3 European Mantle Cell Lymphoma (MCL) Elderly trial (ClinicalTrials.gov identifier: NCT00209209) confirmed the 2012 primary readout that rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) followed by rituximab maintenance until progression in older patients with MCL results in superior clinical outcomes and supports maintenance with rituximab extending beyond 2 years as safe and effective.

Median follow-up of this updated readout, published in the Journal of Clinical Oncology, was 7.6 years. Previously, overall survival (OS) was superior in the R-CHOP group (280 patients) compared with the rituximab, fludarabine, and cyclophosphamide (R-FC) group (280 patients), and improvements persisted, with a median OS of 6.4 years in the R-CHOP arm and 3.9 years in the R-FC arm (P =.0054).

In the original trial design, patients who responded to induction were randomly assigned to receive maintenance with either rituximab (87 patients) or interferon alfa (97) until progression.

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Patients who received rituximab maintenance after responding to R-CHOP induction had a median progression-free survival (PFS) of 5.4 years and a median OS of 9.8 years. In comparison, in patients who received interferon alfa maintenance, median PFS was significantly shorter at 1.9 years (P <.001), as was median OS at 7.1 years (P =.0026).

At 2 years after initiation of R-CHOP, 58% of responders assigned to rituximab maintenance were still on therapy. At 5 years, this proportion decreased to 32%.

Following R-FC, maintenance with rituximab was correlated with a surprisingly high incidence of death in remission at 5 years of 22%. Following R-CHOP, rituximab maintenance was associated with low toxicity, with grade 3 to 4 leukopenia or infection occurring in fewer than 5% of patients. The postinduction toxicity profile of rituximab maintenance was more pronounced in the R-FC arm, with grade 3 to 4 leukopenia occurring in up to 40% of patients and frequent grade 3 to 4 infections occurring in up to 15% of patients.

“In conclusion, the excellent results of R-CHOP followed by rituximab maintenance for older patients with MCL persisted in a mature follow-up,” wrote the researchers. “Prolongation of rituximab maintenance beyond 2 or 3 years is effective and safe.”

Reference

  1. Kluin-Nelemans HC, Hoster E, Hermine O, et al. Treatment of older patients with mantle cell lymphoma (MCL): long-term follow-up of the Randomized European MCL Elderly Trial [published online December 5, 2019]. J Clin Oncol. doi:10.1200/JCO.19.01294

This article originally appeared on Hematology Advisor