TY - JOUR
T1 - Rituximab-CHOP With Early Rituximab Intensification for Diffuse Large B-Cell Lymphoma: A Randomized Phase III Trial of the HOVON and the Nordic Lymphoma Group (HOVON-84)
AU - Lugtenburg, P.J.
AU - Brown, P.D.
AU - van der Holt, B.
AU - D'Amore, F.A.
AU - Koene, H.R.
AU - de Jongh, E.
AU - Fijnheer, R.
AU - van Esser, J.W.
AU - Bohmer, L.H.
AU - Pruijt, J.F.
AU - Verhoef, G.E.
AU - Hoogendoorn, M.
AU - Bilgin, M.Y.
AU - Nijland, M.
AU - van der Burg-de Graauw, N.C.
AU - Oosterveld, M.
AU - Jie, K.S.G.
AU - Larsen, T.S.
AU - van der Poel, M.W.
AU - Leijs, M.B.
AU - Silbermann, M.H.
AU - Kooy, M.V.
AU - Beeker, A.
AU - Kersten, M.J.
AU - Doorduijn, J.K.
AU - Tick, L.W.
AU - Brouwer, R.E.
AU - Lam, K.H.
AU - Burggraaff, C.N.
AU - de Keizer, B.
AU - Arens, A.I.
AU - de Jong, D.
AU - Hoekstra, O.S.
AU - Zijlstra-Baalbergen, J.M.
PY - 2020/10/10
Y1 - 2020/10/10
N2 - PURPOSEImmunochemotherapy 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.PATIENTS AND METHODSA 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.RESULTSCR 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; P = .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; P = .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; P = .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; P = .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.CONCLUSIONEarly rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.
AB - PURPOSEImmunochemotherapy 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.PATIENTS AND METHODSA 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.RESULTSCR 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; P = .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; P = .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; P = .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; P = .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.CONCLUSIONEarly rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.
KW - chemotherapy
KW - dose-dense rituximab
KW - doxorubicin
KW - elderly-patients
KW - exposure
KW - non-hodgkin-lymphoma
KW - optimization
KW - plus cyclophosphamide
KW - response assessment
KW - vincristine
KW - RESPONSE ASSESSMENT
KW - DOXORUBICIN
KW - CHEMOTHERAPY
KW - PLUS CYCLOPHOSPHAMIDE
KW - DOSE-DENSE RITUXIMAB
KW - VINCRISTINE
KW - NON-HODGKIN-LYMPHOMA
KW - OPTIMIZATION
KW - ELDERLY-PATIENTS
KW - EXPOSURE
U2 - 10.1200/JCO.19.03418
DO - 10.1200/JCO.19.03418
M3 - Article
C2 - 32730183
VL - 38
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 29
ER -