Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze IV, časopisecké články, multicentrická studie
PubMed
30168134
DOI
10.1111/bjh.15539
Knihovny.cz E-zdroje
- Klíčová slova
- Hodgkin lymphoma, brentuximab vedotin, novel anti-tumour agents, phase IV, relapsed/refractory,
- MeSH
- brentuximab vedotin MeSH
- dospělí MeSH
- Hodgkinova nemoc farmakoterapie mortalita MeSH
- imunokonjugáty aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití MeSH
- mladiství MeSH
- následné studie MeSH
- přežití bez známek nemoci MeSH
- prospektivní studie MeSH
- protokoly protinádorové kombinované chemoterapie MeSH
- rizikové faktory MeSH
- senioři MeSH
- transplantace kmenových buněk MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- multicentrická studie MeSH
- Názvy látek
- brentuximab vedotin MeSH
- imunokonjugáty MeSH
Some patients with relapsed/refractory Hodgkin lymphoma (HL) are not considered suitable for stem cell transplant (SCT) and have a poor prognosis. This phase IV study (NCT01990534) evaluated brentuximab vedotin (1·8 mg/kg intravenously once every 3 weeks) in 60 patients (aged ≥18 years) with CD30-positive relapsed/refractory HL, a history of ≥1 prior systemic chemotherapy regimen, who were considered unsuitable for SCT/multi-agent chemotherapy. Primary endpoint was overall response rate (ORR) per independent review facility (IRF). Secondary endpoints included duration of response (DOR), progression-free survival (PFS) per IRF, overall survival (OS), proportion proceeding to SCT and safety. The ORR was 50%, with 12% CR; 47% proceeded to SCT. Median DOR was 4·6 months and median duration of CR was 6·1 months. After a median follow-up of 6·9 and 16·6 months, median PFS and OS were 4·8 months (95% confidence interval, 3·0-5·3) and not reached, respectively; estimated OS rate was 86% at 12 months. Most common adverse events (≥10%) were peripheral neuropathy (35%), pyrexia (18%), diarrhoea and neutropenia (each 10%). Brentuximab vedotin showed notable activity with a safety profile consistent with known toxicities, and may act as a bridge to SCT, enabling high-risk patients who achieve suboptimal response to frontline/salvage chemotherapy/radiotherapy to receive potentially curative SCT.
Department of Haematology Ankara University School of Medicine Ankara Turkey
Department of Haematology Charles University Prague Czech Republic
Department of Haematology Dokuz Eylul University Izmir Turkey
Department of Haematology Jagiellonian University Kraków Poland
Department of Haematology Medical University of Gdańsk Gdańsk Poland
Department of Internal Medicine University Hospital Cologne Cologne Germany
Department of Lymphoid Malignancy Maria Sklodowska Curie Institute Oncology Centre Warszawa Poland
Department of Medicine Hospital Pulau Pinang Pulau Pinang Malaysia
Department of Medicine Siriraj Hospital Bangkok Thailand
Oncology Centre Ramathibodi Hospital Mahidol University Bangkok Thailand
Citace poskytuje Crossref.org
