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.
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Authors | Pier Luigi Zinzani, Simonetta Viviani, Antonella Anastasia, Umberto Vitolo, Stefano Luminari, Francesco Zaja, Paolo Corradini, Michele Spina, Ercole Brusamolino, Alessandro M Gianni, Armando Santoro, Barbara Botto, Enrico Derenzini, Cinzia Pellegrini, Lisa Argnani |
Journal | Haematologica
(Haematologica)
Vol. 98
Issue 8
Pg. 1232-6
(Aug 2013)
ISSN: 1592-8721 [Electronic] Italy |
PMID | 23645687
(Publication Type: Journal Article, Multicenter Study, Observational Study)
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Chemical References |
- Immunoconjugates
- Brentuximab Vedotin
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Topics |
- Adolescent
- Adult
- Aged
- Brentuximab Vedotin
- Child
- Disease-Free Survival
- Female
- Follow-Up Studies
- General Practice
(methods)
- Hodgkin Disease
(diagnosis, drug therapy, epidemiology)
- Humans
- Immunoconjugates
(therapeutic use)
- Italy
(epidemiology)
- Male
- Middle Aged
- Retrospective Studies
- Secondary Prevention
- Young Adult
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