title: Brentuximab vedotin in relapsed/refractory Hodgkin's lymphoma: the Italian experience and results of its use in daily clinical practice outside clinical trials.
abstract: Clinical trial results indicate that brentuximab vedotin brings considerable promise for the treatment of patients with relapsed or refractory Hodgkin's lymphoma. A retrospective multicenter study was conducted on 65 heavily pretreated patients who underwent therapy through a Named Patient Program in Italy (non trial-setting). The primary study endpoint was the objective response rate; secondary endpoints were safety, overall survival and progression-free survival. The best overall response rate (70.7%), including 21.5% complete responses, was observed at the first restaging after the third cycle of treatment. After a median follow up of 13.2 months, the overall survival rate at 20 months was 73.8% while the progression-free survival rate at 20 months was 24.2%. Globally nine patients are in continuous complete response with a median follow up of 14 months (range, 10-19 months). Four patients proceeded to autotransplantation and nine to allotransplantation. The most frequent extra-hematologic toxicity was peripheral neuropathy, observed in 21.5% of cases (9 patients with grade 1/2 and 5 patients with grade 3/4); neurological toxicity led to discontinuation of treatment in three patients and to dose reduction in four. In general the treatment was well tolerated and toxicities, both hematologic and extra-hematologic, were manageable. This report indicates and confirms that brentuximab vedotin as a single agent is effective and safe also when used in standard, everyday clinical practice outside a clinical trial. Best overall responses were recorded after three or four cycles and showed that brentuximab vedotin provides an effective bridge to further therapeutic interventions.
authors: 1Institute of Hematology L. and A. Seràgnoli, S. Orsola-Malpighi Hospital, Bologna, Italy. pierluigi.zinzani@unibo.it
authors: Pier Luigi
authors: PL
authors: Zinzani
authors: Simonetta
authors: S
authors: Viviani
authors: Antonella
authors: A
authors: Anastasia
authors: Umberto
authors: U
authors: Vitolo
authors: Stefano
authors: S
authors: Luminari
authors: Francesco
authors: F
authors: Zaja
authors: Paolo
authors: P
authors: Corradini
authors: Michele
authors: M
authors: Spina
authors: Ercole
authors: E
authors: Brusamolino
authors: Alessandro M
authors: AM
authors: Gianni
authors: Armando
authors: A
authors: Santoro
authors: Barbara
authors: B
authors: Botto
authors: Enrico
authors: E
authors: Derenzini
authors: Cinzia
authors: C
authors: Pellegrini
authors: Lisa
authors: L
authors: Argnani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000079963:Brentuximab Vedotin; D002648:Child; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D058006:General Practice / Q000379:methods; D006689:Hodgkin Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D018796:Immunoconjugates; D000079963:Brentuximab Vedotin
references: Lancet. 1993 Apr 24;341(8852):1051-4
references: 8096958
references: N Engl J Med. 2010 Nov 4;363(19):1812-21
references: 21047225
references: J Clin Oncol. 2007 Feb 10;25(5):579-86
references: 17242396
references: Am J Hematol. 2010 May;85(5):320-4
references: 20229590
references: Haematologica. 2013 Apr;98(4):611-4
references: 23065511
references: N Engl J Med. 2003 Jun 12;348(24):2386-95
references: 12802024
references: J Clin Oncol. 1999 Jan;17(1):222-9
references: 10458237
references: Lancet. 2002 Jun 15;359(9323):2065-71
references: 12086759
references: Clin Cancer Res. 2012 Jan 1;18(1):248-55
references: 22080439
references: Blood. 2011 Nov 10;118(19):5119-25
references: 21937701
references: N Engl J Med. 1992 Nov 19;327(21):1478-84
references: 1383821
references: Blood. 2012 Jun 28;119(26):6379-81
references: 22611160
references: J Clin Oncol. 2012 Jun 20;30(18):2183-9
references: 22454421
references: Blood. 2012 Aug 16;120(7):1470-2
references: 22786877
references: J Clin Oncol. 2012 Jun 20;30(18):2197-203
references: 22547596