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)
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.; Bohmer, 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, Josee M.
(2020) Journal of Clinical Oncology, volume 38, issue 29, pp. 3377 - 3387
(Article)
Abstract
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
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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.
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Keywords: Oncology, Cancer Research, Journal Article
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology
Note: Funding Information: The funding sources had no role in design, data collection, data analysis, or interpretation of the findings. Supported by Grant No. CKTO 2006-14 from the Dutch Cancer Society, which funded clinical data management, and by Roche Nederland, which funded the pharmacokinetic and clinical studies and supplied the off-label rituximab. Publisher Copyright: © 2020 by American Society of Clinical Oncology. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
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