Clinical Research Papers:
Italian real life experience with brentuximab vedotin: results of a large observational study on 234 relapsed/refractory Hodgkin’s lymphoma
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Abstract
Cinzia Pellegrini1,*, Alessandro Broccoli1,*, Alessandro Pulsoni2, Luigi Rigacci3, Caterina Patti4, Guido Gini5, Donato Mannina6, Monica Tani7, Chiara Rusconi8, Alessandra Romano9, Anna Vanazzi10, Barbara Botto11, Armando Santoro12, Stefan Hoaus13, Gian Matteo Rigolin14, Pellegrino Musto15, Patrizio Mazza16, Stefano Molica17, Paolo Corradini18, Angelo Fama19, Francesco Gaudio20, Michele Merli21, Fioravante Ronconi22, Giuseppe Gritti23, Daniele Vallisa24, Patrizia Tosi25, Anna Marina Liberati26, Antonello Pinto27, Vincenzo Pavone28, Filippo Gherlinzoni29, Maria Paola Bianchi30, Stefano Volpetti31, Livio Trentin32, Maria Cecilia Goldaniga33, Maurizio Bonfichi34, Amalia De Renzo35, Corrado Schiavotto36, Michele Spina37, Angelo Michele Carella38, Vittorio Stefoni1, Lisa Argnani1 and Pier Luigi Zinzani1
1 Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Bologna, Italy
2 Department of Cellular Biotechnologies and Hematology, Hematology, Sapienza University, Rome, Italy
3 Department of Hematology, University and Hospital Careggi, Firenze, Italy
4 Department of Hematology, Azienda Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy
5 Department of Hematology, Ospedali Riuniti di Ancona, Ancona, Italy
6 Hematology Unit, Ospedale Papardo, Messina, Italy
7 Hematology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy
8 Division of Hematology, Niguarda Hospital, Milan, Italy
9 Division of Hematology, AOU, Catania, Italy
10 European Institute of Oncology, Milano, Italy
11 Hematology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Torino, Italy
12 Oncology and Hematology, Humanitas Cancer Center, Rozzano, Italy
13 Institute of Hematology, Catholic University, Rome, Italy
14 Hematology Section, St. Anna University Hospital, Cona, Ferrara, Italy
15 Scientific Direction, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture, Pz, Italy
16 Ospedale Moscati, Department of Hematology-Oncology, Taranto, Italy
17 Department of Hematology, Ciaccio-Pugliese Hospital, Catanzaro, Italy
18 Department of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy
19 Hematology Unit, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy
20 Hematology Unit, Policlinico di Bari, Bari, Italy
21 Hematology, Ospedale di Circolo, Fondazione Macchi, Varese, Italy
22 Division of Hematology and Stem Cell Transplantation Unit, Cardarelli Hospital, Napoli, Italy
23 Department of Hematology, Hospital Papa Giovanni XXIII, Bergamo, Italy
24 Division of Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy
25 Hematology Unit, Infermi Hospital Rimini, Rimini, Italy
26 Hematology, Ospedale Perugia, Perugia, Italy
27 Hematology-Oncology and Stem Cell Transplantation Unit, National Cancer Institute, Fondazione Pascale, IRCCS, Napoli, Italy
28 Division of Hematology, Ospedale G. Panico, Tricase, Lecce, Italy
29 Hematology Unit, Ca’ Foncello Hospital, Treviso, Italy
30 Sant’Andrea Hospital, Sapienza University, Rome, Italy
31 Department of Hematology, DISM, Azienda Sanitaria Universitaria Integrata, Udine, Italy
32 Department of Medicine, Hematology and Clinical Immunology Unit, University of Padua, Padua, Italy
33 Onco-Hematology Unit, Fondazione Ca’ Granda IRCCS Ospedale Maggiore Policlinico, Milan, Italy
34 Hematology, IRCCS Policlinico San Matteo, Pavia, Italy
35 Hematology, AOU Federico II Napoli, Napoli, Italy
36 Hematology, San Bortolo Hospital, Vicenza, Italy
37 Division of Medical Oncology A, National Cancer Institute, Aviano, Italy
38 Division of Hematology 1, IRCCS A.O.U. San Martino IST, Genova, Italy
* These authors have contributed equally to this work
Correspondence to:
Pier Luigi Zinzani, email:
Keywords: brentuximab vedotin, long-term response, real life, Hodgkin’s lymphoma, stem cell transplantation
Received: April 04, 2017 Accepted: May 08, 2017 Published: May 23, 2017
Abstract
A large Italian multicenter observational retrospective study was conducted on the use of brentuximab vedotin (BV) for patients with relapsed Hodgkin’s lymphoma (HL) to check if clinical trial results are confirmed even in a real life context. 234 CD30+ HL patients were enrolled. Best response was observed after a median of 4 cycles in 140 patients (59.8%): 74 (31.6%) patients obtained a complete response (CR) and 66 (28.2%) achieved a partial response (PR); overall response rate at the end of the treatment was 48.3% (62 CR and 51 PR). The best response rate was higher in the elderly subset: 14 (50%) CR and 5 (17.8%) PR. Disease free survival was 26.3% at 3 years and progression free survival 31.9% at 4.5 years. Duration of response did not differ for who achieved at least PR and then either did or did not undergo consolidative transplant. Overall, the treatment was well tolerated and no death has been linked to BV-induced toxicity.
Our report confirms activity in elderly patients, duration of response unrelated to the consolidation with transplant procedure, the relevance of the CR status at first restaging, and the role of BV as a bridge to transplant for chemorefractory patients.
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PII: 18114