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Oncotarget. 2018 May 4;9(34):23443-23450. doi: 10.18632/oncotarget.25215. eCollection 2018 May 4.

Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma.

Author information

1
Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna, Italy.
2
Operative Unit of Medical Oncology, IRCCS Fondazione Maugeri, Pavia, Italy.
3
Department of Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
4
Division of Medical Oncology A, National Cancer Institute, Aviano, Italy.
5
Department of Hematology, DISM, Azienda Sanitaria Universitaria Integrata, Udine, Italy.
6
Division of Hematology, Department of Molecular Biotechnologies and Scienze for Health, University Torino, Torino, Italy.
7
Unit of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
8
Hematology and Transplantation Unit, Regina Elena National Cancer Institute, Roma, Italy.
9
Unit of Hematology, Ospedale di Circolo, Fondazione Macchi, Varese, Italy.
10
Department of Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy.
11
Hematology Service, Medicine Department, Rovigo Hospital, Rovigo, Italy.
12
Division of Hematology, Niguarda Ca' Granda Hospital, Milano, Italy.
13
OncoHematology Unit, Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico, Milano, Italy.
14
Unit of Hematology, Vito Fazzi Hospital, Lecce, Italy.
15
Hematology Unit, Infermi Hospital Rimini, Rimini, Italy.
16
IRCCS, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
17
Unit of Oncology/Hematology, Azienda Ospedaliera "Pugliese-Ciaccio", Catanzaro, Italy.
18
Unit of Hematology, Arcispedale Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy.
19
Unit of Hematology, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy.
20
Institute of Hematology, Università Cattolica del Sacro Cuore, Roma, Italy.
21
Hemato-Oncology Division, European Institute of Oncology, Milano, Italy.
22
Unit of Hematology, University-Hospital Città della Salute e della Scienza di Torino, Torino, Italy.
23
Department of Medical Sciences, Hematology Unit, University of Modena and Reggio Emilia, Modena, Italy.
24
Unit of Hematology, Ospedale San Gennaro di Napoli, Napoli, Italy.
25
Unit of Hematology, Ospedale Santa Croce E Carle, Cuneo, Italy.
26
Ematologia Clinica, Ospedale Maggiore, Trieste, Italy.
27
Clinica di Ematologia Ospedali Riuniti, Ancona, Italy.
28
Unit of Hematology, University of Padova, Padova, Italy.
29
Humanitas Cancer Center, Istituto Clinico Humanitas, Rozzano, Italy.

Abstract

Although sometimes presenting as an indolent lymphoma, mantle cell lymphoma (MCL) is an aggressive disease, hardly curable with standard chemo-immunotherapy. Current approaches have greatly improved patients' outcomes, nevertheless the disease is still characterized by high relapse rates. Before approval by EMA, Italian patients with relapsed/refractory MCL were granted ibrutinib early access through a Named Patient Program (NPP). An observational, retrospective, multicenter study was conducted. Seventy-seven heavily pretreated patients were enrolled. At the end of therapy there were 14 complete responses and 14 partial responses, leading to an overall response rate of 36.4%. At 40 months overall survival was 37.8% and progression free survival was 30%; disease free survival was 78.6% at 4 years: 11/14 patients are in continuous complete response with a median of 36 months of follow up. Hematological toxicities were manageable, and main extra-hematological toxicities were diarrhea (9.4%) and lung infections (9.0%). Overall, 4 (5.2%) atrial fibrillations and 3 (3.9%) hemorrhagic syndromes occurred. In conclusions, thrombocytopenia, diarrhea and lung infections are the relevant adverse events to be clinically focused on; regarding effectiveness, ibrutinib is confirmed to be a valid option for refractory/relapsed MCL also in a clinical setting mimicking the real world.

KEYWORDS:

ibrutinib; mantle cell lymphoma; real life; refractory; relapsed

Conflict of interest statement

CONFLICTS OF INTEREST No potential conflicts of interest were disclosed.

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