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Research Papers:

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

Alessandro Broccoli, Beatrice Casadei, Alice Morigi, Federico Sottotetti, Manuel Gotti, Michele Spina, Stefano Volpetti, Simone Ferrero, Francesco Spina, Francesco Pisani, Michele Merli, Carlo Visco, Rossella Paolini, Vittorio Ruggero Zilioli, Luca Baldini, Nicola Di Renzo, Patrizia Tosi, Nicola Cascavilla, Stefano Molica, Fiorella Ilariucci, Gian Matteo Rigolin, Francesco D'Alò, Anna Vanazzi, Elisa Santambrogio, Roberto Marasca, Lucia Mastrullo, Claudia Castellino, Giovanni Desabbata, Ilaria Scortechini, Livio Trentin, Lucia Morello, Lisa Argnani and Pier Luigi Zinzani _

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Oncotarget. 2018; 9:23443-23450. https://doi.org/10.18632/oncotarget.25215

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Abstract

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

Correspondence to:

Pier Luigi Zinzani, email: pierluigi.zinzani@unibo.it

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

Received: January 30, 2018     Accepted: April 07, 2018     Published: May 04, 2018

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.


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