TY - JOUR
T1 - Treatment of Older Patients with Mantle-Cell Lymphoma
AU - Kluin-Nelemans, Hanneke C.
AU - Hoster, Eva
AU - Hermine, Olivier
AU - Walewski, Jan
AU - Trneny, Marek
AU - Geisler, Christian H.
AU - Stilgenbauer, Stephan
AU - Thieblemont, Catherine
AU - Vehling-Kaiser, Ursula
AU - Doorduijn, Jeanette K.
AU - Coiffier, Bertrand
AU - Forstpointner, Roswitha
AU - Tilly, Herve
AU - Kanz, Lothar
AU - Feugier, Pierre
AU - Szymczyk, Michal
AU - Hallek, Michael
AU - Kremers, Stephan
AU - Lepeu, Gerard
AU - Sanhes, Laurence
AU - Zijlstra, Josee M.
AU - Bouabdallah, Redah
AU - Lugtenburg, Elly
AU - Macro, Margaret
AU - Pfreundschuh, Michael
AU - Prochazka, Vit
AU - Di Raimondo, Francesco
AU - Ribrag, Vincent
AU - Uppenkamp, Michael
AU - Andre, Marc
AU - Klapper, Wolfram
AU - Hiddemann, Wolfgang
AU - Unterhalt, Michael
AU - Dreyling, Martin H.
PY - 2012/8/9
Y1 - 2012/8/9
N2 - 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.
AB - 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.
U2 - 10.1056/NEJMoa1200920
DO - 10.1056/NEJMoa1200920
M3 - Article
C2 - 22873532
SN - 0028-4793
VL - 367
SP - 520
EP - 531
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 6
ER -