TY - JOUR
T1 - Rituximab-CHOP With Early Rituximab Intensification for Diffuse Large B-Cell Lymphoma
T2 - A Randomized Phase III Trial of the HOVON and the Nordic Lymphoma Group (HOVON-84)
AU - Lugtenburg, Pieternella Johanna
AU - de Nully Brown, Peter
AU - van der Holt, Bronno
AU - D'Amore, Francesco A
AU - Koene, Harry R
AU - de Jongh, Eva
AU - Fijnheer, Rob
AU - van Esser, Joost W
AU - Böhmer, Lara H
AU - Pruijt, Johannes F
AU - Verhoef, Gregor E
AU - Hoogendoorn, Mels
AU - Bilgin, Memis Y
AU - Nijland, Marcel
AU - van der Burg-de Graauw, Nicole C
AU - Oosterveld, Margreet
AU - Jie, Kon-Siong G
AU - Larsen, Thomas Stauffer
AU - van der Poel, Marjolein W
AU - Leijs, Maria B
AU - Silbermann, Matthijs H
AU - van Marwijk Kooy, Marinus
AU - Beker, Aart
AU - Kersten, Marie J
AU - Doorduijn, Jeanette K
AU - Tick, Lidwine W
AU - Brouwer, Rolf E
AU - Lam, King H
AU - Burggraaff, Coreline N
AU - de Keizer, Bart
AU - Arens, Anne I
AU - de Jong, Daphne
AU - Hoekstra, Otto S
AU - Zijlstra-Baalbergen, Josée M
PY - 2020/7/30
Y1 - 2020/7/30
N2 - PURPOSE: 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.PATIENTS AND METHODS: 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.RESULTS: 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; 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.CONCLUSION: Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.
AB - PURPOSE: 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.PATIENTS AND METHODS: 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.RESULTS: 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; 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.CONCLUSION: Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.
U2 - 10.1200/JCO.19.03418
DO - 10.1200/JCO.19.03418
M3 - Article
C2 - 32730183
SP - JCO1903418
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
ER -