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  • Rituximab-CHOP With Early R...
    Lugtenburg, Pieternella Johanna; de Nully Brown, Peter; van der Holt, Bronno; D'Amore, Francesco A; Koene, Harry R; de Jongh, Eva; Fijnheer, Rob; van Esser, Joost W; Böhmer, Lara H; Pruijt, Johannes F; Verhoef, Gregor E; Hoogendoorn, Mels; Bilgin, Memis Y; Nijland, Marcel; van der Burg-de Graauw, Nicole C; Oosterveld, Margreet; Jie, Kon-Siong G; Larsen, Thomas Stauffer; van der Poel, Marjolein W; Leijs, Maria B; Silbermann, Matthijs H; van Marwijk Kooy, Marinus; Beeker, Aart; Kersten, Marie J; Doorduijn, Jeanette K; Tick, Lidwine W; Brouwer, Rolf E; Lam, King H; Burggraaff, Coreline N; de Keizer, Bart; Arens, Anne I; de Jong, Daphne; Hoekstra, Otto S; Zijlstra-Baalbergen, Josée M

    Journal of clinical oncology, 10/2020, Letnik: 38, Številka: 29
    Journal Article

    Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become standard of care for patients with diffuse large B-cell lymphoma (DLBCL). This randomized trial assessed whether rituximab intensification during the first 4 cycles of R-CHOP could improve the outcome of these patients compared with standard R-CHOP. A total of 574 patients with DLBCL age 18 to 80 years were randomly assigned to induction therapy with 6 or 8 cycles of R-CHOP-14 with (RR-CHOP-14) or without (R-CHOP-14) intensification of rituximab in the first 4 cycles. The primary end point was complete remission (CR) on induction. Analyses were performed by intention to treat. CR was achieved in 254 (89%) of 286 patients in the R-CHOP-14 arm and 249 (86%) of 288 patients in the RR-CHOP-14 arm (hazard ratio HR, 0.82; 95% CI, 0.50 to 1.36; = .44). After a median follow-up of 92 months (range, 1-131 months), 3-year failure-free survival was 74% (95% CI, 68% to 78%) in the R-CHOP-14 arm versus 69% (95% CI, 63% to 74%) in the RR-CHOP-14 arm (HR, 1.26; 95% CI, 0.98 to 1.61; = .07). Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55; = .15). Overall survival at 3 years was 81% (95% CI, 76% to 85%) in the R-CHOP-14 arm versus 76% (95% CI, 70% to 80%) in the RR-CHOP-14 arm (HR, 1.27; 95% CI, 0.97 to 1.67; = .09). Patients between ages 66 and 80 years experienced significantly more toxicity during the first 4 cycles in the RR-CHOP-14 arm, especially neutropenia and infections. Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.