Rituximab maintenance doubles remission duration in MCL

Hanneke Kluin-Nelemans, MD

London—New research has shown that rituximab maintenance doubles remission duration in patients with mantle cell lymphoma (MCL) compared to those on interferon-alfa (IFN) maintenance. Patients on rituximab experienced a median of 77 months remission duration compared to 24 months with IFN.

Hanneke C. Kluin-Nelemans, MD, of the University Medical Center Groningen in The Netherlands, presented the results at the 16th Congress of the European Hematology Association held June 9 - 12.

Patients with MCL older than 60 years survive only a median of 3 - 5 years, most often because of relapse after induction therapy. So the European Mantle Cell Lymphoma Network set out to see if relapses could be reduced by using rituximab as maintenance therapy. Dr Kluin-Nelemans indicated this is the first study of MCL in the elderly.

The study was conducted in 8 countries from 2004 - October 2010 and enrolled 560 patients older than 60 years with stage II-IV disease who were not eligible for high-dose therapy.

Patients were randomized to 2 different induction schemes, thrice-weekly R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) for 6-8 cycles or 4-weekly R-FC (rituximab, fludarabine, cyclophosphamide) for 6 cycles. Patients were a median age of 70 years, 68% were male, and 79% had stage IV disease.

Two hundred eighty-eight patients achieved complete remission or partial remission and were randomized to maintenance. The rituximab arm received 1 maintenance dose every 2 months, and the IFN arm received 1-3 doses per week. Two hundred twenty-three were evaluable.

After a median follow-up of 33 months, patients on rituximab maintenance had more than double the remission duration of those on IFN (P=0.0109). Overall survival, however, was not different between the 2 arms.

Dr Kluin-Nelemans pointed out that patients treated with R-CHOP and rituximab maintenance appeared to have some survival advantage compared with those who received IFN maintenance.

Rituximab maintenance was safe and tolerated well by a majority of patients. Eighty percent of patients on the IFN arm discontinued therapy, compared with 34% in the rituximab arm.

Grade 3-4 leukocytopenia and thrombocytopenia were higher in the IFN arm, and nonhematologic grade 3-4 adverse events were rare, except for infections, which occurred in 7% of patients in each arm.

At 4 years after the start of therapy, 77% of patients on rituximab and 62% on IFN were still alive. And 87% who had received R-CHOP induction followed by rituximab maintenance were surviving at 4 years.

Patients who responded to induction therapy but chose not to continue with maintenance therapy fared poorly, with a median remission duration of 26 months.

These results led the investigators to recommend that R-CHOP followed by rituximab, one dose every 2 months, be the new standard of care for elderly patients with MCL.

Discussion

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