Lucie Oberic1, Frederic Peyrade2, Mathieu Puyade3, Christophe Bonnet4, Peggy Dartigues-Cuillères5, Bettina Fabiani6, Philippe Ruminy7, Hervé Maisonneuve8, Julie Abraham9, Catherine Thieblemont10, Pierre Feugier11, Gilles Salles12, Fontanet Bijou13, Gian-Matteo Pica14, Gandhi Damaj15, Corinne Haioun16, René-Olivier Casasnovas17, Hassan Farhat18, Ronan Le Calloch19, Agathe Waultier-Rascalou20, Sandra Malak21, Jerome Paget22, Elodie Gat22, Hervé Tilly23, Fabrice Jardin23. 1. Department of Hematology, Institut Universitaire du Cancer, Toulouse-Oncopole, Toulouse, France. 2. Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France. 3. Department of Oncology-Haematology and Cell Therapy, CHU, Poitiers, INSERM, Inserm CIC 1402, Poitiers, France. 4. Clinical Hematology Unit, CHU Liège, Liège Université, Campus Universitaire de Sart Tilman, Liège, Belgique. 5. Anapath Research Unit (EA) EA4340 and Pathology Laboratory, Versailles University and APHP, Ambroise Paré Hospital, Boulogne, France. 6. Department of Pathology, Hopital Saint-Antoine, APHP, Paris, France. 7. INSERM U1245, Centre Henri Becquerel, Rouen, France. 8. Department of Clinical Hematology, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France. 9. Department of Hematology, CHU Dupuytren, Limoges, France. 10. APHP, Hopital Saint-Louis, Hemato-oncologie; Université de Paris, Paris Diderot, Paris, France. 11. Department of Haematology, Centre Hospitalier Régional Universitaire de Nancy, Vandoeuvre Les Nancy, France. 12. Department of Hematology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre Benite, France. 13. Department of Hematology, Hospital Bergonié, Bordeaux, France. 14. Department of Hematology, Centre Hospitalier Métropole Savoie, Chambery, France. 15. Department of Hematology, CHU Caen, Caen, France. 16. Department of Hematology, Henri Mondor University Hospital, UPEC, Creteil, France. 17. Department of Hematology and INSERM1231, CHU Dijon Bourgogne, Dijon, France. 18. Department of Hematology, Centre Hospitalier de Versailles André Mignot, Versailles, France. 19. Centre hospitalier de Quimper Cornouaille/Université de Bretagne Occidentale, France. 20. Department of Hematology, Centre Hospitalier Universitaire Nimes Caremeau, Nîmes, France. 21. Department of Hematology, CLCC Rene Huguenin Institut Curie, Saint-Cloud, France. 22. LYSARC, The Lymphoma Academic Research Organisation, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France. 23. Department of Hematology, Centre Henri Becquerel, UNIROUEN, University of Normandy, INSERM U1245, Rouen, France.
Abstract
PURPOSE: The prognosis of elderly patients with diffuse large B-cell lymphoma (DLBCL) is worse than that of young patients. An attenuated dose of chemotherapy-cyclophosphamide, doxorubicin, vincristine, and prednisone plus rituximab (R-miniCHOP)-is a good compromise between efficacy and safety in very elderly patients. In combination with R-CHOP (R2-CHOP), lenalidomide has an acceptable level of toxicity and may mitigate the negative prognosis of the non-germinal center B-cell-like phenotype. The Lymphoma Study association conducted a multicentric, phase III, open-label, randomized trial to compare R-miniCHOP and R2-miniCHOP. PATIENTS AND METHODS: Patients of age 80 years or older with untreated DLBCL were randomly assigned into the R-miniCHOP21 group or the R2-miniCHOP21 group for six cycles and stratified according to CD10 expression and age. The first cycle of rituximab was delivered by IV on D1 after a prephase and then delivered subcutaneously on D1 of cycles 2-6. Lenalidomide was delivered at a dose of 10 mg once daily on D1-D14 of each cycle. The primary end point was overall survival (OS). RESULTS: A total of 249 patients with new DLBCL were randomly assigned (127 R-miniCHOP and 122 R2-miniCHOP). The median age was 83 years (range, 80-96), and 55% of the patients were classified as non-GCB. The delivered dose for each R-miniCHOP compound was similar in both arms. Over a median follow-up of 25.1 months, the intention-to-treat analysis revealed that R2-miniCHOP did not improve OS (2-year OS 66% in R-miniCHOP and 65.7% in R2-miniCHOP arm, P = .98) in the overall population or in the non-GCB population. Grade 3-4 adverse events occurred in 53% of patients with R-miniCHOP and in 81% of patients with R2-miniCHOP. CONCLUSION: The addition of lenalidomide to R-miniCHOP does not improve OS. Rituximab delivered subcutaneously was safe in this population.
RCT Entities:
PURPOSE: The prognosis of elderly patients with diffuse large B-cell lymphoma (DLBCL) is worse than that of young patients. An attenuated dose of chemotherapy-cyclophosphamide, doxorubicin, vincristine, and prednisone plus rituximab (R-miniCHOP)-is a good compromise between efficacy and safety in very elderly patients. In combination with R-CHOP (R2-CHOP), lenalidomide has an acceptable level of toxicity and may mitigate the negative prognosis of the non-germinal center B-cell-like phenotype. The Lymphoma Study association conducted a multicentric, phase III, open-label, randomized trial to compare R-miniCHOP and R2-miniCHOP. PATIENTS AND METHODS: Patients of age 80 years or older with untreated DLBCL were randomly assigned into the R-miniCHOP21 group or the R2-miniCHOP21 group for six cycles and stratified according to CD10 expression and age. The first cycle of rituximab was delivered by IV on D1 after a prephase and then delivered subcutaneously on D1 of cycles 2-6. Lenalidomide was delivered at a dose of 10 mg once daily on D1-D14 of each cycle. The primary end point was overall survival (OS). RESULTS: A total of 249 patients with new DLBCL were randomly assigned (127 R-miniCHOP and 122 R2-miniCHOP). The median age was 83 years (range, 80-96), and 55% of the patients were classified as non-GCB. The delivered dose for each R-miniCHOP compound was similar in both arms. Over a median follow-up of 25.1 months, the intention-to-treat analysis revealed that R2-miniCHOP did not improve OS (2-year OS 66% in R-miniCHOP and 65.7% in R2-miniCHOP arm, P = .98) in the overall population or in the non-GCB population. Grade 3-4 adverse events occurred in 53% of patients with R-miniCHOP and in 81% of patients with R2-miniCHOP. CONCLUSION: The addition of lenalidomide to R-miniCHOP does not improve OS. Rituximab delivered subcutaneously was safe in this population.
Authors: L Hounsome; T A Eyre; R Ireland; A Hodson; R Walewska; K Ardeshna; S Chaganti; P McKay; A Davies; C P Fox; N Kalakonda; P A Fields Journal: Br J Cancer Date: 2021-10-05 Impact factor: 7.640
Authors: P Connor Johnson; Alisha Yi; Nora Horick; Hermioni L Amonoo; Richard A Newcomb; Mitchell W Lavoie; Julia Rice; Matthew J Reynolds; Christine S Ritchie; Ryan D Nipp; Areej El-Jawahri Journal: Oncologist Date: 2021-08-12 Impact factor: 5.837