Carfilzomib, lenalidomide, dexamethasone (KRD) in BTKi relapsed or refractory mantle cell lymphoma: A phase II study from Fondazione Italiana Linfomi. in British journal of haematology / Br J Haematol. 2024 Oct;205(4):1404-1410. doi: 10.1111/bjh.19617. Epub 2024 Jun 28.
2024
AOU Città della Salute di Torino
AOU Novara
Tipo pubblicazione
Multicenter Study
Autori/Collaboratori (14)Vedi tutti...
Zaja F
AOU Maggiore della Carità, SCDU Ematologia, Novara, Italy.
Dodero A
Azienda Ospedaliera Universitaria Senese, U.O.C. Ematologia, Siena, Italy.
Gaidano G
Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
et alii...
Abstract
Mantle cell lymphoma (MCL) is a rare lymphoproliferative neoplasm considered incurable, with a median survival of 3-5?years. In recent years, Bruton's tyrosine kinase inhibitors (BTKi) have been introduced, demonstrating high therapeutic activity. However, the prognosis for MCL patients failing ibrutinib therapy is particularly poor, with a survival expectation of a few months. In this phase II trial, we assessed the efficacy and safety of the carfilzomib-lenalidomide-dexamethasone (KRD) combination in MCL patients who were relapsed/refractory (R/R) or intolerant to BTKi and in need of treatment. The primary objective of the study was to evaluate the antitumor efficacy of the KRD combination in terms of 12-month overall survival (12-month OS). From September 2019 to December 2020, 16 patients were enrolled from 11 Italian centers. After a median follow-up of 2.37 months (95% CI 0.92-6.47), the 12-month OS was 13%. The rate of grade 3-4 adverse events (AEs) was 35%, and the overall response rate (ORR) was 19%. These results led to the premature termination of enrollment, as defined in the protocol stopping rules. The efficacy of the KRD combination in advanced-stage MCL patients who are R/R to BTKi is unsatisfactory and too toxic.
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PMID : 38938122
DOI : 10.1111/bjh.19617
Keywords
mantle cell lymphoma; clinical haematology; lenalidomide; carfilzomib; Drug Resistance, Neoplasm; Middle Aged; Oligopeptides/therapeutic use/adverse effects/administration & dosage; Agammaglobulinaemia Tyrosine Kinase/antagonists & inhibitors; Aged, 80 and over; Protein Kinase Inhibitors/therapeutic use/adverse effects/administration & dosage; Aged; Female; Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse effects/administration & dosage; Lenalidomide/administration & dosage/therapeutic use/adverse effects; Italy; Male; Dexamethasone/administration & dosage/adverse effects/therapeutic use; Lymphoma, Mantle-Cell/drug therapy/mortality; Humans;