R-CHOP Plus Rituximab Maintenance Therapy Safe, Effective in Older Patients With MCL

Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) followed by rituximab maintenance therapy is effective and safe for older patients with mantle cell lymphoma (MCL), according to results from a long-term update of the European MCL Elderly clinical trial (J Clin Oncol. 2019 Dec 5. Epub ahead of print).

“In an update of the randomized, open-label, phase 3 European MCL Elderly trial…published in 2012, we aimed to confirm results on long-term outcome focusing on efficacy and safety of long-term use of rituximab maintenance,” explained Hanneke C. Kluin-Nelemans, MD, PhD, University Medical Center Groningen, University of Groningen, the Netherlands, and colleagues.

A total of 560 patients with newly diagnosed MCL underwent randomization for induction with R-CHOP or rituximab, fludarabine, and cyclophosphamide (R-FC). Of these patients, 316 responders then underwent a second randomization to receive rituximab or interferon-alfa maintenance therapy.

Dr Kluin-Nelemans and colleagues compared progression-free survival (PFS) from the maintenance randomization and overall survival (OS) from the initial or maintenance randomizations.

After a median follow-up of 7.6 years, the median OS with R-CHOP was 6.4 years (n = 280) versus 3.9 years with R-FC (n = 280); this was consistent with OS differences previously described. Among patients who responded to R-CHOP, the median PFS and OS with maintenance rituximab (n = 87) were 5.4 and 9.8 years, respectively, compared with 1.9 years (P <.001) and 7.1 years (P = .0026) with interferon-alfa (n = 97).

Among patients treated with R-CHOP, rituximab maintenance was still ongoing 2 years after initiation in 58% of patients and 5 years after initiation in 32% of patients.

Rituximab maintenance after R-FC was tied to a 22% cumulative incidence of death in remission at 5 years. After R-CHOP, toxicity with rituximab was low with grade 3-4 leukopenia or infection occurring in <5% of patients. Rituximab toxicity was more common after R-FC, with grade 3-4 leukopenia in up to 40% of patients and infections in up to 15% of patients.

“The excellent results of R-CHOP followed by rituximab maintenance until progression for older patients with MCL persisted in a mature follow-up. Prolongation of rituximab maintenance beyond 2 years is effective and safe,” Dr Kluin-Nelemans and colleagues concluded.—Janelle Bradley