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

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.

• Authors: 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, Pier Luigi Zinzani
• Journal: Oncotarget (Oncotarget) Vol. 9 Issue 34 Pg. 23443-23450 (May 04 2018) ISSN: 1949-2553 [Electronic] United States
• PMID: 29805746 (Publication Type: Journal Article)