Treatment of Older Patients with Mantle-Cell Lymphoma

Hanneke C. Kluin-Nelemans, Eva Hoster, Olivier Hermine, Jan Walewski, Marek Trneny, Christian H. Geisler, Stephan Stilgenbauer, Catherine Thieblemont, Ursula Vehling-Kaiser, Jeanette K. Doorduijn, Bertrand Coiffier, Roswitha Forstpointner, Herve Tilly, Lothar Kanz, Pierre Feugier, Michal Szymczyk, Michael Hallek, Stephan Kremers, Gerard Lepeu, Laurence SanhesJosee M. Zijlstra, Redah Bouabdallah, Elly Lugtenburg, Margaret Macro, Michael Pfreundschuh, Vit Prochazka, Francesco Di Raimondo, Vincent Ribrag, Michael Uppenkamp, Marc Andre, Wolfram Klapper, Wolfgang Hiddemann, Michael Unterhalt, Martin H. 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.
Original languageEnglish
Pages (from-to)520-531
Number of pages12
JournalNew England Journal of Medicine
Volume367
Issue number6
DOIs
Publication statusPublished - 9 Aug 2012

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  • EMC MM-02-41-03

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