Italian real life experience with ibrutinib: results of a large observational study on 77 relapsed/refractory mantle cell lymphoma
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Alessandro Broccoli1, Beatrice Casadei1, Alice Morigi1, Federico Sottotetti2, Manuel Gotti3, Michele Spina4, Stefano Volpetti5, Simone Ferrero6, Francesco Spina7, Francesco Pisani8, Michele Merli9, Carlo Visco10, Rossella Paolini11, Vittorio Ruggero Zilioli12, Luca Baldini13, Nicola Di Renzo14, Patrizia Tosi15, Nicola Cascavilla16, Stefano Molica17, Fiorella Ilariucci18, Gian Matteo Rigolin19, Francesco D'Alò20, Anna Vanazzi21, Elisa Santambrogio22, Roberto Marasca23, Lucia Mastrullo24, Claudia Castellino25, Giovanni Desabbata26, Ilaria Scortechini27, Livio Trentin28, Lucia Morello29, Lisa Argnani1 and Pier Luigi Zinzani1
1Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna, Italy
2Operative Unit of Medical Oncology, IRCCS Fondazione Maugeri, Pavia, Italy
3Department of Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
4Division of Medical Oncology A, National Cancer Institute, Aviano, Italy
5Department of Hematology, DISM, Azienda Sanitaria Universitaria Integrata, Udine, Italy
6Division of Hematology, Department of Molecular Biotechnologies and Scienze for Health, University Torino, Torino, Italy
7Unit of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
8Hematology and Transplantation Unit, Regina Elena National Cancer Institute, Roma, Italy
9Unit of Hematology, Ospedale di Circolo, Fondazione Macchi, Varese, Italy
10Department of Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy
11Hematology Service, Medicine Department, Rovigo Hospital, Rovigo, Italy
12Division of Hematology, Niguarda Ca’ Granda Hospital, Milano, Italy
13OncoHematology Unit, Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico, Milano, Italy
14Unit of Hematology, Vito Fazzi Hospital, Lecce, Italy
15Hematology Unit, Infermi Hospital Rimini, Rimini, Italy
16IRCCS, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
17Unit of Oncology/Hematology, Azienda Ospedaliera "Pugliese-Ciaccio", Catanzaro, Italy
18Unit of Hematology, Arcispedale Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy
19Unit of Hematology, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy
20Institute of Hematology, Università Cattolica del Sacro Cuore, Roma, Italy
21Hemato-Oncology Division, European Institute of Oncology, Milano, Italy
22Unit of Hematology, University-Hospital Città della Salute e della Scienza di Torino, Torino, Italy
23Department of Medical Sciences, Hematology Unit, University of Modena and Reggio Emilia, Modena, Italy
24Unit of Hematology, Ospedale San Gennaro di Napoli, Napoli, Italy
25Unit of Hematology, Ospedale Santa Croce E Carle, Cuneo, Italy
26Ematologia Clinica, Ospedale Maggiore, Trieste, Italy
27Clinica di Ematologia Ospedali Riuniti, Ancona, Italy
28Unit of Hematology, University of Padova, Padova, Italy
29Humanitas Cancer Center, Istituto Clinico Humanitas, Rozzano, Italy
Pier Luigi Zinzani, email: email@example.com
Keywords: ibrutinib; mantle cell lymphoma; relapsed; refractory; real life
Received: January 30, 2018 Accepted: April 07, 2018 Published: May 04, 2018
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.
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