Subcutaneous Rituximab-MiniCHOP Compared With Subcutaneous Rituximab-MiniCHOP Plus Lenalidomide in Diffuse Large B-Cell Lymphoma for Patients Age 80 Years or Older

Creators: Oberic, Lucie; Peyrade, Frédéric; Puyade, Mathieu; Bonnet, Christophe; Dartigues-Cuillères, Peggy; Fabiani, Bettina; Ruminy, Philippe; Maisonneuve, Hervé; Abraham, Julie; Thieblemont, Catherine; Feugier, Pierre; Salles, Gilles; Bijou, Fontanet; Pica, Gian Matteo; Damaj, Gandhi Laurent; Haioun, Corinne; Casasnovas, René Olivier; Farhat, Hassan; Le Calloch, Ronan; Waultier-Rascalou, Agathe; Malak, Sandra; Paget, Jerome; Gat, Elodie; Tilly, Hervè; Jardin, Fabrice

Others:: Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037) ; Université Toulouse III - Paul Sabatier (UT3) ; Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM); Pôle de Chirurgie Oncologique générale, Gynécologique et Mammaire [Centre Antoine-Lacassagne] ; Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL) ; UNICANCER-Université Côte d'Azur (UCA)-UNICANCER-Université Côte d'Azur (UCA); CIC - Poitiers ; Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM); Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH) ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay; Service de neurophysiologie [CHU Saint-Antoine] ; CHU Saint-Antoine [AP-HP] ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND) ; Université de Rouen Normandie (UNIROUEN) ; Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM); Hôpital Dupuytren [CHU Limoges]; Hopital Saint-Louis [AP-HP] (AP-HP) ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy); Hospices Civils de Lyon (HCL); Institut Bergonié [Bordeaux] ; UNICANCER; Centre Hospitalier Métropole Savoie [Chambéry]; Laboratoire d'Hématologie Biologique [CHU Caen] ; Université de Caen Normandie (UNICAEN) ; Normandie Université (NU)-Normandie Université (NU)-CHU Caen ; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN); CHU Henri Mondor; CHU Dijon ; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); Centre Hospitalier de Versailles André Mignot (CHV); Université de Bretagne Occidentale - UFR Médecine et Sciences de la Santé (UBO UFR MSS) ; Université de Brest (UBO); Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes) ; Centre Hospitalier Universitaire de Nîmes (CHU Nîmes); Hôpital René HUGUENIN (Saint-Cloud); The Lymphoma Academic Research Organisation [Lyon] (LYSARC)

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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 populatio

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Subcutaneous Rituximab-MiniCHOP Compared With Subcutaneous Rituximab-MiniCHOP Plus Lenalidomide in Diffuse Large B-Cell Lymphoma for Patients Age 80 Years or Older

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