Carfilzomib, lenalidomide, dexamethasone (KRD) in BTKi relapsed or refractory mantle cell lymphoma: A phase II study from Fondazione Italiana Linfomi

被引：0

作者：

Cavallo, Federica ^{[1
,2
]}

Clerico, Michele ^{[1
]}

Lucchini, Elisa ^{[3
]}

Castiglione, Anna ^{[4
,5
]}

Re, Alessandro ^{[6
]}

Zilioli, Vittorio Ruggiero ^{[7
]}

Visco, Carlo ^{[8
]}

Tani, Monica ^{[9
]}

Olivieri, Jacopo ^{[10
]}

Arcaini, Luca ^{[11
,12
]}

Fabbri, Alberto ^{[13
]}

Gaidano, Gianluca ^{[14
]}

Dodero, Anna ^{[15
]}

Zaja, Francesco ^{[3
,16
]}

机构：

[1] Univ Hosp AOU Citta Salute & Sci, Div Hematol U, Turin, Italy

[2] Univ Turin, Dept Mol Biotechnol & Hlth Sci, Div Hematol U, Turin, Italy

[3] Azienda Sanit Univ Giuliano Isontina, Osped Maggiore, UCO Ematol, Trieste, Italy

[4] Unit Canc Epidemiol CPO Piemonte, Turin, Italy

[5] Univ Turin, Turin, Italy

[6] ASST Spedali Civili Brescia, Div Hematol, Brescia, Italy

[7] ASST Grande Osped Metropolitano Niguarda, Div Hematol, Milan, Italy

[8] Univ Verona, Dept Engn Innovat Med, Sect Hematol, Verona, Italy

[9] Osped S Maria Croci, UOC Ematol, Ravenna, Italy

[10] ASUFC, Div Hematol & Stem Cell Transplantat, Udine, Italy

[11] Univ Pavia, Dept Mol Med, Pavia, Italy

[12] Fdn IRCCS Policlin San Matteo, Div Hematol, Pavia, Italy

[13] Azienda Osped Univ Senese, UOC Ematol, Siena, Italy

[14] AOU Maggiore Car, SCDU Ematol, Novara, Italy

[15] Fdn IRCCS Ist Nazl Tumori Milano, Ematol, Milan, Italy

[16] Univ Trieste, DSM, UCO Ematol, Trieste, Italy

来源：

BRITISH JOURNAL OF HAEMATOLOGY | 2024年 / 205卷 / 04期

关键词：

carfilzomib; clinical haematology; lenalidomide; mantle cell lymphoma; SINGLE-AGENT LENALIDOMIDE; CLINICAL-FEATURES; IBRUTINIB; OUTCOMES; ARM;

D O I：

10.1111/bjh.19617

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1404 / 1410

页数：7

共 33 条

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