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.
Brentuximab vedotin in relapsed/refractory Hodgkin's lymphoma : the Italian experience and results of its use in daily clinical practice outside clinical trials / P.L. Zinzani, S. Viviani, A. Anastasia, U. Vitolo, S. Luminari, F. Zaja, P. Corradini, M. Spina, E. Brusamolino, A.M. Gianni, A. Santoro, B. Botto, E. Derenzini, C. Pellegrini, L. Argnani. - In: HAEMATOLOGICA. - ISSN 0390-6078. - 98:8(2013 Aug), pp. 1232-1236.
|Titolo:||Brentuximab vedotin in relapsed/refractory Hodgkin's lymphoma : the Italian experience and results of its use in daily clinical practice outside clinical trials|
|Settore Scientifico Disciplinare:||Settore MED/06 - Oncologia Medica|
|Data di pubblicazione:||ago-2013|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.3324/haematol.2012.083048|
|Appare nelle tipologie:||01 - Articolo su periodico|