Treatment of Older Patients with Mantle-Cell Lymphoma

HC Kluin-Nelemans, E Hoster, O Hermine, J Walewski, M Trneny, CH Geisler, S Stilgenbauer, C Thieblemont, U Vehling-Kaiser, Jeanette Doorduijn, B Coiffier, R Forstpointner, H Tilly, L Kanz, P Feugier, M Szymczyk, M Hallek, S Kremers, G Lepeu, L SanhesJM Zijlstra, R Bouabdallah, Elly Lugtenburg, M Macro, M Pfreundschuh, V Prochazka, F Di Raimondo, V Ribrag, M Uppenkamp, M Andre, W Klapper, W Hiddemann, M Unterhalt, MH Dreyling

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Abstract

BACKGROUND The long-term prognosis for older patients with mantle-cell lymphoma is poor. Chemoimmunotherapy results in low rates of complete remission, and most patients have a relapse. We investigated whether a fludarabine-containing induction regimen improved the complete-remission rate and whether maintenance therapy with rituximab prolonged remission. METHODS We randomly assigned patients 60 years of age or older with mantle-cell lymphoma, stage II to IV, who were not eligible for high-dose therapy to six cycles of rituximab, fludarabine, and cyclophosphamide (R-FC) every 28 days or to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) every 21 days. Patients who had a response underwent a second randomization to maintenance therapy with rituximab or interferon alfa, each given until progression. RESULTS Of the 560 patients enrolled, 532 were included in the intention-to-treat analysis for response, and 485 in the primary analysis for response. The median age was 70 years. Although complete-remission rates were similar with R-FC and R-CHOP (40% and 34%, respectively; P = 0.10), progressive disease was more frequent with R-FC (14%, vs. 5% with R-CHOP). Overall survival was significantly shorter with R-FC than with R-CHOP (4-year survival rate, 47% vs. 62%; P = 0.005), and more patients in the R-F CONCLUSIONS R-CHOP induction followed by maintenance therapy with rituximab is effective for older patients with mantle-cell lymphoma. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT00209209.)
Original languageUndefined/Unknown
Pages (from-to)520-531
Number of pages12
JournalNew England Journal of Medicine
Volume367
Issue number6
DOIs
Publication statusPublished - 2012

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  • EMC MM-02-41-03

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