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 IlariucciGian 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, Pier Luigi Zinzani

Research output: Contribution to journalArticle

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. Seventyseven 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.

Original languageEnglish
Pages (from-to)23443-23450
Number of pages8
JournalOncotarget
Volume9
Issue number34
DOIs
Publication statusPublished - May 1 2018

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Keywords

  • Ibrutinib
  • Mantle cell lymphoma
  • Real life
  • Refractory
  • Relapsed

ASJC Scopus subject areas

  • Oncology

Cite this

Broccoli, A., Casadei, B., Morigi, A., Sottotetti, F., Gotti, M., Spina, M., Volpetti, S., Ferrero, S., Spina, F., Pisani, F., Merli, M., Visco, C., Paolini, R., Zilioli, V. R., Baldini, L., Di Renzo, N., Tosi, P., Cascavilla, N., Molica, S., ... Zinzani, P. L. (2018). Italian real life experience with ibrutinib: Results of a large observational study on 77 relapsed/refractory mantle cell lymphoma. Oncotarget, 9(34), 23443-23450. https://doi.org/10.18632/oncotarget.25215