Haematologica (Nov 2017)
Italian real-life experience with brentuximab vedotin: results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma
- Alessandro Broccoli,
- Cinzia Pellegrini,
- Alice Di Rocco,
- Benedetta Puccini,
- Caterina Patti,
- Guido Gini,
- Donato Mannina,
- Monica Tani,
- Chiara Rusconi,
- Alessandra Romano,
- Anna Vanazzi,
- Barbara Botto,
- Carmelo Carlo-Stella,
- Stefan Hohaus,
- Pellegrino Musto,
- Patrizio Mazza,
- Stefano Molica,
- Paolo Corradini,
- Angelo Fama,
- Francesco Gaudio,
- Michele Merli,
- Angela Gravetti,
- Giuseppe Gritti,
- Annalisa Arcari,
- Patrizia Tosi,
- Anna Marina Liberati,
- Antonello Pinto,
- Vincenzo Pavone,
- Filippo Gherlinzoni,
- Virginia Naso,
- Stefano Volpetti,
- Livio Trentin,
- Maria Cecilia Goldaniga,
- Maurizio Bonfichi,
- Amalia De Renzo,
- Corrado Schiavotto,
- Michele Spina,
- Sergio Storti,
- Angelo Michele Carella,
- Vittorio Stefoni,
- Lisa Argnani,
- Pier Luigi Zinzani
Affiliations
- Alessandro Broccoli
- Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Italy
- Cinzia Pellegrini
- Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Italy
- Alice Di Rocco
- Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy
- Benedetta Puccini
- Hematology Department, University and Hospital Careggi, Firenze, Italy
- Caterina Patti
- Department of Hematology, Azienda Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy
- Guido Gini
- Department of Hematology, Ospedali Riuniti di Ancona, Italy
- Donato Mannina
- Hematology Unit, Ospedale Papardo, Messina, Italy
- Monica Tani
- Hematology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy
- Chiara Rusconi
- Division of Hematology, Niguarda Hospital, Milan, Italy
- Alessandra Romano
- Division of Hematology, AOU, Catania, Italy
- Anna Vanazzi
- European Institute of Oncology, Milan, Italy
- Barbara Botto
- SC Ematologia, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Torino, Italy
- Carmelo Carlo-Stella
- Oncology and Hematology, Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano, Italy
- Stefan Hohaus
- Institute of Hematology, Catholic University, Rome, Italy
- Pellegrino Musto
- Scientific Direction, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture (Pz), Italy
- Patrizio Mazza
- Ospedale Moscati Department of Hematology-Oncology, Taranto, Italy
- Stefano Molica
- Department of Hematology, Ciaccio-Pugliese Hospital, Catanzaro, Italy
- Paolo Corradini
- Department of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Italy
- Angelo Fama
- Hematology Unit, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy
- Francesco Gaudio
- Hematology Unit, Policlinico di Bari, Italy
- Michele Merli
- Hematology, Ospedale di Circolo, Fondazione Macchi, Varese, Italy
- Angela Gravetti
- Division of Hematology and Stem Cell Transplantation Unit, Cardarelli Hospital, Napoli, Italy
- Giuseppe Gritti
- Department of Hematology, Hospital Papa Giovanni XXIII, Bergamo, Italy
- Annalisa Arcari
- Division of Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy
- Patrizia Tosi
- Hematology Unit, Infermi Hospital Rimini, Italy
- Anna Marina Liberati
- Hematology, Ospedale Perugia, Italy
- Antonello Pinto
- Hematology-Oncology and Stem Cell Transplantation Unit, National Cancer Institute, Fondazione Pascale, IRCCS, Napoli, Italy
- Vincenzo Pavone
- Division of Hematology, Ospedale G. Panico, Tricase, Lecce, Italy
- Filippo Gherlinzoni
- Hematology Unit, Ca’ Foncello Hospital, Treviso, Italy
- Virginia Naso
- Sant’Andrea Hospital – Sapienza, Rome, Italy
- Stefano Volpetti
- Department of Hematology, DISM, Azienda Sanitaria Universitaria Integrata, Udine, Italy
- Livio Trentin
- Hematology and Clinical Immunology Unit, Department of Medicine, University of Padua, Italy
- Maria Cecilia Goldaniga
- OncoHematology Unit, Fondazione Ca’ Granda IRCCS Ospedale Maggiore Policlinico, Milan, Italy
- Maurizio Bonfichi
- Hematology, IRCCS Policlinico San Matteo, Pavia, Italy
- Amalia De Renzo
- Hematology, AOU Federico II Napoli, Italy
- Corrado Schiavotto
- Hematology, San Bortolo Hospital, Vicenza, Italy
- Michele Spina
- Division of Medical Oncology A, National Cancer Institute, Aviano, Italy
- Sergio Storti
- Hematology, Università Cattolica Sacro Cuore Campobasso, Italy
- Angelo Michele Carella
- Division of Hematology 1, IRCCS A.O.U. San Martino IST, Genova, Italy
- Vittorio Stefoni
- Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Italy
- Lisa Argnani
- Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Italy
- Pier Luigi Zinzani
- Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Italy
- DOI
- https://doi.org/10.3324/haematol.2017.171355
- Journal volume & issue
-
Vol. 102,
no. 11
Abstract
Between November 2012 and July 2014, in accordance with national law 648/96, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in everyday clinical practice to check whether clinical trial results are confirmed in a real-life context. The primary endpoint of this study was best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of four cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. The overall response rate was 62.5%. At the latest follow up, 15/18 patients are still in complete remission (3 with consolidation). The progression-free survival rate at 24 months was 39.1% and the disease-free survival rate at the same time was 54% (median not reached). All the long-term responders were aged
