Ibrutinib in patients with relapsed/refractory mantle cell lymphoma: a real-life, retrospective, multicenter trial on behalf of the "RTL" (regional Tuscan lymphoma network).

Mantle cell lymphoma ibrutinib prognosis safety survival

Journal

American journal of blood research
ISSN: 2160-1992
Titre abrégé: Am J Blood Res
Pays: United States
ID NLM: 101569577

Informations de publication

Date de publication:
2021
Historique:
received: 09 06 2021
accepted: 14 07 2021
entrez: 20 9 2021
pubmed: 21 9 2021
medline: 21 9 2021
Statut: epublish

Résumé

Relapsed or refractory (R/R) mantle-cell lymphoma (MCL) patients have a poor prognosis and their management is challenging, in absence of a golden standard as salvage treatment. Bruton's tyrosine kinase inhibitor ibrutinib represents an effective treatment for R/R MCL patients. We investigated ibrutinib efficacy and safety in daily clinical practice, together with factors that could predict disease outcome. We retrospectively analyzed 69 consecutive R/R MCL patients managed in 10 Tuscan onco-hematological centers. The treatment regimen consisted of oral, continuous, single-agent ibrutinib, maximum dosage of 560 mg once per day, until disease progression. Overall response rate was 62.3%, with a CR rate of 39.1%. After a median follow-up of 15.6 months, 40/69 patients (58%) were alive, the main cause of death was progressive disease (PD, 22/69 cases, 31.9%). Median progression-free survival (PFS) and overall survival (OS) were 17 and 34.8 months. Inferior PFS was associated with >1 prior line of therapy and B symptoms. Ibrutinib refractoriness was associated with inferior OS, median OS after ibrutinib failure was only 5 months. In this real-life setting ibrutinib treatment prolonged survival in R/R MCL patients, without unexpected adverse events. Patients receiving ibrutinib as 2

Sections du résumé

BACKGROUND BACKGROUND
Relapsed or refractory (R/R) mantle-cell lymphoma (MCL) patients have a poor prognosis and their management is challenging, in absence of a golden standard as salvage treatment. Bruton's tyrosine kinase inhibitor ibrutinib represents an effective treatment for R/R MCL patients. We investigated ibrutinib efficacy and safety in daily clinical practice, together with factors that could predict disease outcome.
PATIENTS AND METHODS METHODS
We retrospectively analyzed 69 consecutive R/R MCL patients managed in 10 Tuscan onco-hematological centers. The treatment regimen consisted of oral, continuous, single-agent ibrutinib, maximum dosage of 560 mg once per day, until disease progression.
RESULTS RESULTS
Overall response rate was 62.3%, with a CR rate of 39.1%. After a median follow-up of 15.6 months, 40/69 patients (58%) were alive, the main cause of death was progressive disease (PD, 22/69 cases, 31.9%). Median progression-free survival (PFS) and overall survival (OS) were 17 and 34.8 months. Inferior PFS was associated with >1 prior line of therapy and B symptoms. Ibrutinib refractoriness was associated with inferior OS, median OS after ibrutinib failure was only 5 months.
DISCUSSION AND CONCLUSION CONCLUSIONS
In this real-life setting ibrutinib treatment prolonged survival in R/R MCL patients, without unexpected adverse events. Patients receiving ibrutinib as 2

Identifiants

pubmed: 34540345
pmc: PMC8446834

Types de publication

Journal Article

Langues

eng

Pagination

373-383

Informations de copyright

AJBR Copyright © 2021.

Déclaration de conflit d'intérêts

None.

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Auteurs

Emanuele Cencini (E)

Unit of Hematology, Azienda Ospedaliera Universitaria Senese and University of Siena Siena, Italy.

Bianca Mecacci (B)

Unit of Hematology, Azienda Ospedaliera Universitaria Senese and University of Siena Siena, Italy.

Francesca Morelli (F)

Lymphoma Unit, Hematology Department, Careggi Hospital and University of Florence Florence, Italy.

Francesco Ghio (F)

Unit of Hematology, Azienda Ospedaliera Universitaria Pisana and University of Pisa Pisa, Italy.

Ilaria Romano (I)

Lymphoma Unit, Hematology Department, Careggi Hospital and University of Florence Florence, Italy.

Silvia Birtolo (S)

SOS Oncoematologia Pistoia e Pescia Italy.

Federico Simonetti (F)

UOC Ematologia Dipartimentale ATNO, Ospedale Versilia Lido di Camaiore, Italy.

Valentina Zoi (V)

UOS Oncoematologia Usl Toscana Sud Est Arezzo, Italy.

Sabrina Moretti (S)

SOC Ematologia Clinica e Oncoematologia Firenze, Italy.

Emanuela Sant'Antonio (E)

UOC Ematologia Aziendale, Azienda USL Toscana Nordovest, Ospedale S. Luca Lucca, Italy.

Annarosa Cuccaro (A)

UOC Ematologia Aziendale, Azienda USL Toscana Nordovest, Spedali Riuniti Livorno, Italy.

Simone Santini (S)

SOS Oncoematologia, Ospedale S. Stefano Prato, Italy.

Sofia Kovalchuk (S)

Lymphoma Unit, Hematology Department, Careggi Hospital and University of Florence Florence, Italy.

Sara Galimberti (S)

Unit of Hematology, Azienda Ospedaliera Universitaria Pisana and University of Pisa Pisa, Italy.

Monica Bocchia (M)

Unit of Hematology, Azienda Ospedaliera Universitaria Senese and University of Siena Siena, Italy.

Alberto Fabbri (A)

Unit of Hematology, Azienda Ospedaliera Universitaria Senese and University of Siena Siena, Italy.

Classifications MeSH