Lenalidomide plus rituximab for the initial treatment of frail older patients with DLBCL: the FIL_ReRi phase 2 study.

Abstract

Treatment of diffuse large B-cell lymphoma (DLBCL) in older patients is challenging, especially for those who are not eligible for anthracycline-containing regimens. Fondazione Italiana Linfomi (FIL) started the FIL_ReRi study, a 2-stage single-arm trial to investigate the activity and safety of the chemo-free combination of rituximab and lenalidomide (R2) in ≥70-year-old untreated frail patients with DLBCL. Frailty was prospectively defined using a simplified geriatric assessment tool. Patients were administered a maximum of 6 28-day cycles of 20 mg oral lenalidomide from days 2 to 22 and IV rituximab 375 mg/m2 on day 1, with response assessment after cycles 4 and 6. Patients with partial response or complete response (CR) at cycle 6 were administered lenalidomide 10 mg/d from days 1 to 21 for every 28 cycles for a total of 12 cycles or until progression or unacceptable toxicity. The primary end point was the overall response rate (ORR) after cycle 6; the coprimary end point was the rate of grade 3 or 4 extrahematological toxicity. The ORR was 50.8%, with 27.7% CR. After a median follow-up of 24 months, the median progression-free survival was 14 months, and the 2-year duration of response was 64%. Thirty-four patients experienced extrahematological toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events grade ≥3. The activity of the R2 combination was observed in a significant proportion of subjects, warranting further exploration of a chemo-free approach in frail older patients with DLBCL. This trial was registered at EudraCT as #2015-003371-29 and clinicaltrials.gov as #NCT02955823.

• Authors: Guido Gini, Monica Tani, Alessandra Tucci, Luigi Marcheselli, Marina Cesaretti, Monica Bellei, Anna Pascarella, Filippo Ballerini, Mauro Petrini, Francesco Merli, Attilio Olivieri, Francesco Lanza, Ombretta Annibali, Vittorio Ruggero Zilioli, Anna Marina Liberati, Maria Chiara Tisi, Annalisa Arcari, Dario Marino, Gerardo Musuraca, Vincenzo Pavone, Alberto Fabbri, Samantha Pozzi, Donato Mannina, Caterina Plenteda, Melania Celli, Stefano Luminari
• Journal: Blood (Blood) Vol. 142 Issue 17 Pg. 1438-1447 (10 26 2023) ISSN: 1528-0020 [Electronic] United States
• PMID: 37418685 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: © 2023 by The American Society of Hematology.

Chemical References

• Rituximab
• Lenalidomide

Topics

• Humans
• Aged
• Rituximab (therapeutic use)
• Lenalidomide (therapeutic use)
• Frail Elderly
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Lymphoma, Large B-Cell, Diffuse (pathology)
• Treatment Outcome