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Haematologica. 2017 Nov;102(11):1931-1935. doi: 10.3324/haematol.2017.171355. Epub 2017 Aug 3.

Italian real-life experience with brentuximab vedotin: results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma.

Author information

1
Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Italy.
2
Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy.
3
Hematology Department, 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, 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, Milan, Italy.
11
SC Ematologia, Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Torino, Italy.
12
Oncology and Hematology, Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano, Italy.
13
Institute of Hematology, Catholic University, Rome, Italy.
14
Scientific Direction, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero in Vulture (Pz), Italy.
15
Ospedale Moscati Department of Hematology-Oncology, Taranto, Italy.
16
Department of Hematology, Ciaccio-Pugliese Hospital, Catanzaro, Italy.
17
Department of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Italy.
18
Hematology Unit, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
19
Hematology Unit, Policlinico di Bari, Italy.
20
Hematology, Ospedale di Circolo, Fondazione Macchi, Varese, Italy.
21
Division of Hematology and Stem Cell Transplantation Unit, Cardarelli Hospital, Napoli, Italy.
22
Department of Hematology, Hospital Papa Giovanni XXIII, Bergamo, Italy.
23
Division of Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy.
24
Hematology Unit, Infermi Hospital Rimini, Italy.
25
Hematology, Ospedale Perugia, Italy.
26
Hematology-Oncology and Stem Cell Transplantation Unit, National Cancer Institute, Fondazione Pascale, IRCCS, Napoli, Italy.
27
Division of Hematology, Ospedale G. Panico, Tricase, Lecce, Italy.
28
Hematology Unit, Ca' Foncello Hospital, Treviso, Italy.
29
Sant'Andrea Hospital - Sapienza, Rome, Italy.
30
Department of Hematology, DISM, Azienda Sanitaria Universitaria Integrata, Udine, Italy.
31
Hematology and Clinical Immunology Unit, Department of Medicine, University of Padua, Italy.
32
OncoHematology Unit, Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico, Milan, Italy.
33
Hematology, IRCCS Policlinico San Matteo, Pavia, Italy.
34
Hematology, AOU Federico II Napoli, Italy.
35
Hematology, San Bortolo Hospital, Vicenza, Italy.
36
Division of Medical Oncology A, National Cancer Institute, Aviano, Italy.
37
Hematology, Università Cattolica Sacro Cuore Campobasso, Italy.
38
Division of Hematology 1, IRCCS A.O.U. San Martino IST, Genova, Italy.
39
Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Italy pierluigi.zinzani@unibo.it.

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 <30 years at first infusion. The treatment was well tolerated even in this real-life context and no deaths were linked to drug toxicity. Brentuximab vedotin induces clinical responses quite rapidly, i.e. within the first four cycles of treatment in most responders, thus enabling timely use of transplantation. For patients ineligible for transplant or for those in whom a transplant procedure failed, brentuximab vedotin may represent a feasible effective therapeutic option in everyday clinical practice.

PMID:
28775121
PMCID:
PMC5664397
DOI:
10.3324/haematol.2017.171355
[Indexed for MEDLINE]
Free PMC Article

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