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. 2021 Apr 10;39(11):1203-1213.
doi: 10.1200/JCO.20.02666. Epub 2021 Jan 14.

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

Lucie Oberic  1 , Frederic Peyrade  2 , Mathieu Puyade  3 , Christophe Bonnet  4 , Peggy Dartigues-Cuillères  5 , Bettina Fabiani  6 , Philippe Ruminy  7 , Hervé Maisonneuve  8 , Julie Abraham  9 , Catherine Thieblemont  10 , Pierre Feugier  11 , Gilles Salles  12 , Fontanet Bijou  13 , Gian-Matteo Pica  14 , Gandhi Damaj  15 , Corinne Haioun  16 , René-Olivier Casasnovas  17 , Hassan Farhat  18 , Ronan Le Calloch  19 , Agathe Waultier-Rascalou  20 , Sandra Malak  21 , Jerome Paget  22 , Elodie Gat  22 , Hervé Tilly  23 , Fabrice Jardin  23
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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

Lucie Oberic et al. J Clin Oncol. .
Free article

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.

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Conflict of interest statement

Lucie ObericHonoraria: Roche, Janssen-CilagConsulting or Advisory Role: Roche, TakedaTravel, Accommodations, Expenses: Roche, Janssen-Cilag Frederic PeyradeHonoraria: MSD Oncology Mathieu PuyadeTravel, Accommodations, Expenses: Sanofi Pasteur Christophe BonnetConsulting or Advisory Role: Roche Julie AbrahamHonoraria: Sanofi Pasteur, Gilead Sciences, RocheTravel, Accommodations, Expenses: Janssen-Cilag, Abbvie Catherine ThieblemontHonoraria: Celgene, Abbvie, Bayer, Janssen, Roche, Incyte, Novartis, Gilead SciencesResearch Funding: RocheTravel, Accommodations, Expenses: Roche, Janssen-Cilag, Kite/Gilead, Novartis Pierre FeugierHonoraria: Roche/Genentech, Janssen, Gilead Sciences, Amgen, AbbvieConsulting or Advisory Role: Roche/Genentech, Janssen, Abbvie, Gilead Sciences, Amgen, AstraZenecaSpeakers' Bureau: Roche/Genentech, Abbvie, Amgen, Janssen, Gilead SciencesResearch Funding: Roche/Genentech, Gilead Sciences, Janssen, Abbvie, AmgenTravel, Accommodations, Expenses: Amgen, Gilead Sciences, Janssen, Roche/Genentech, Abbvie Gilles SallesHonoraria: Roche/Genentech, Janssen, Celgene, Gilead Sciences, Novartis, Abbvie, MorphoSysConsulting or Advisory Role: Roche/Genentech, Gilead Sciences, Janssen, Celgene, Novartis, Morphosys, Epizyme, Alimera Sciences, Genmab, Debiopharm Group, Velosbio Gandhi DamajConsulting or Advisory Role: Roche/Genentech, Takeda, iqoneResearch Funding: TakedaTravel, Accommodations, Expenses: Pfizee, Roche/Genentech, Abbvie Corinne HaiounHonoraria: Roche France, Janssen-Cilag, Gilead Sciences, Miltenyi Biotec, Amgen, Takeda, Celgene, Novartis,, Servier/PfizerConsulting or Advisory Role: Roche, Celgene, Janssen-Cilag, Gilead Sciences, Takeda, Miltenyi BiotecTravel, Accommodations, Expenses: Roche, Celgene, Amgen René-Olivier CasasnovasHonoraria: Roche/Genentech, Takeda, Gilead Sciences, Bristol-Myers Squibb, Merck, Abbvie, Celgene, JanssenConsulting or Advisory Role: Roche/Genentech, Takeda, Gilead Sciences, Bristol-Myers Squibb, Merck, Abbvie, Celgene, JanssenResearch Funding: Roche/Genentech, Gilead Sciences, TakedaTravel, Accommodations, Expenses: Roche/Genentech, Takeda, Gilead Sciences, Janssen Ronan Le CallochConsulting or Advisory Role: TakedaTravel, Accommodations, Expenses: Janssen-Cilag Hervé TillyHonoraria: Bristol-Myers Squibb, Servier, RocheConsulting or Advisory Role: Karyopharm Therapeutics, Roche, JanssenTravel, Accommodations, Expenses: Roche Fabrice JardinHonoraria: Roche, CelgeneConsulting or Advisory Role: RocheTravel, Accommodations, Expenses: RocheNo other potential conflicts of interest were reported.

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