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 language | English |
|---|---|
| Pages (from-to) | 23443-23450 |
| Number of pages | 8 |
| Journal | Oncotarget |
| Volume | 9 |
| Issue number | 34 |
| DOIs | |
| Publication status | Published - May 1 2018 |
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Keywords
- Ibrutinib
- Mantle cell lymphoma
- Real life
- Refractory
- Relapsed
ASJC Scopus subject areas
- Oncology
Cite this
Italian real life experience with ibrutinib : Results of a large observational study on 77 relapsed/refractory mantle cell lymphoma. / Broccoli, Alessandro; Casadei, Beatrice; Morigi, Alice; Sottotetti, Federico; Gotti, Manuel; Spina, Michele; Volpetti, Stefano; Ferrero, Simone; Spina, Francesco; Pisani, Francesco; Merli, Michele; Visco, Carlo; Paolini, Rossella; Zilioli, Vittorio Ruggero; Baldini, Luca; Di Renzo, Nicola; Tosi, Patrizia; Cascavilla, Nicola; Molica, Stefano; Ilariucci, Fiorella; Rigolin, Gian Matteo; D'Alò, Francesco; Vanazzi, Anna; Santambrogio, Elisa; Marasca, Roberto; Mastrullo, Lucia; Castellino, Claudia; Desabbata, Giovanni; Scortechini, Ilaria; Trentin, Livio; Morello, Lucia; Argnani, Lisa; Zinzani, Pier Luigi.
In: Oncotarget, Vol. 9, No. 34, 01.05.2018, p. 23443-23450.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Italian real life experience with ibrutinib
T2 - Results of a large observational study on 77 relapsed/refractory mantle cell lymphoma
AU - Broccoli, Alessandro
AU - Casadei, Beatrice
AU - Morigi, Alice
AU - Sottotetti, Federico
AU - Gotti, Manuel
AU - Spina, Michele
AU - Volpetti, Stefano
AU - Ferrero, Simone
AU - Spina, Francesco
AU - Pisani, Francesco
AU - Merli, Michele
AU - Visco, Carlo
AU - Paolini, Rossella
AU - Zilioli, Vittorio Ruggero
AU - Baldini, Luca
AU - Di Renzo, Nicola
AU - Tosi, Patrizia
AU - Cascavilla, Nicola
AU - Molica, Stefano
AU - Ilariucci, Fiorella
AU - Rigolin, Gian Matteo
AU - D'Alò, Francesco
AU - Vanazzi, Anna
AU - Santambrogio, Elisa
AU - Marasca, Roberto
AU - Mastrullo, Lucia
AU - Castellino, Claudia
AU - Desabbata, Giovanni
AU - Scortechini, Ilaria
AU - Trentin, Livio
AU - Morello, Lucia
AU - Argnani, Lisa
AU - Zinzani, Pier Luigi
PY - 2018/5/1
Y1 - 2018/5/1
N2 - 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.
AB - 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.
KW - Ibrutinib
KW - Mantle cell lymphoma
KW - Real life
KW - Refractory
KW - Relapsed
UR - http://www.scopus.com/inward/record.url?scp=85046713776&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85046713776&partnerID=8YFLogxK
U2 - 10.18632/oncotarget.25215
DO - 10.18632/oncotarget.25215
M3 - Article
AN - SCOPUS:85046713776
VL - 9
SP - 23443
EP - 23450
JO - Oncotarget
JF - Oncotarget
SN - 1949-2553
IS - 34
ER -