1. 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)
- Author
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Coreline N. Burggraaff, Gregor Verhoef, Otto S. Hoekstra, Marie José Kersten, Lidwine W. Tick, Mels Hoogendoorn, Margreet Oosterveld, Daphne de Jong, Nicole C. H. P. van der Burg-de Graauw, Marinus van Marwijk Kooy, Matthijs H Silbermann, Aart Beeker, Marjolein van der Poel, Bart de Keizer, Eva de Jongh, Jeanette K. Doorduijn, Harry R. Koene, Thomas Stauffer Larsen, Memis Y Bilgin, Lara H Böhmer, Joost W. J. van Esser, Peter de Nully Brown, Marcel Nijland, Maria B.L. Leijs, J.F.M. Pruijt, Anne I.J. Arens, Josée M Zijlstra-Baalbergen, Pieternella J. Lugtenburg, Kon-Siong G. Jie, Rolf E. Brouwer, King H. Lam, Rob Fijnheer, Bronno van der Holt, Francesco d'Amore, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Hematologie (9), Hematology, Health Technology Assessment (HTA), Pathology, Radiology & Nuclear Medicine, Radiotherapy, CCA - Cancer Treatment and Quality of Life, Clinical Haematology, Stem Cell Aging Leukemia and Lymphoma (SALL), Internal medicine, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and quality of life, and Radiology and nuclear medicine
- Subjects
Male ,0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_treatment ,CHOP ,0302 clinical medicine ,Prednisone ,Positron Emission Tomography Computed Tomography ,Antineoplastic Combined Chemotherapy Protocols ,Aged, 80 and over ,response assessment ,DOSE-DENSE RITUXIMAB ,Induction Chemotherapy ,Middle Aged ,CHEMOTHERAPY ,Treatment Outcome ,030220 oncology & carcinogenesis ,Female ,Rituximab ,Lymphoma, Large B-Cell, Diffuse ,Rare cancers Radboud Institute for Health Sciences [Radboudumc 9] ,medicine.drug ,Adult ,medicine.medical_specialty ,Vincristine ,DOXORUBICIN ,Adolescent ,Cyclophosphamide ,plus cyclophosphamide ,elderly-patients ,vincristine ,Maintenance Chemotherapy ,Young Adult ,03 medical and health sciences ,All institutes and research themes of the Radboud University Medical Center ,Internal medicine ,medicine ,Humans ,non-hodgkin-lymphoma ,OPTIMIZATION ,Aged ,Chemotherapy ,business.industry ,medicine.disease ,Lymphoma ,030104 developmental biology ,exposure ,business ,Diffuse large B-cell lymphoma ,Follow-Up Studies - 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 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.
- Published
- 2020
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