Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase IV, Journal Article, Multicenter Study
PubMed
30168134
DOI
10.1111/bjh.15539
Knihovny.cz E-resources
- Keywords
- Hodgkin lymphoma, brentuximab vedotin, novel anti-tumour agents, phase IV, relapsed/refractory,
- MeSH
- Brentuximab Vedotin MeSH
- Adult MeSH
- Hodgkin Disease drug therapy mortality MeSH
- Immunoconjugates administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate MeSH
- Adolescent MeSH
- Follow-Up Studies MeSH
- Disease-Free Survival MeSH
- Prospective Studies MeSH
- Antineoplastic Combined Chemotherapy Protocols MeSH
- Risk Factors MeSH
- Aged MeSH
- Stem Cell Transplantation MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase IV MeSH
- Multicenter Study MeSH
- Names of Substances
- Brentuximab Vedotin MeSH
- Immunoconjugates 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
References provided by Crossref.org
