Publication: Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy
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Issued Date
2018-11-01
Resource Type
ISSN
13652141
00071048
00071048
Other identifier(s)
2-s2.0-85052817145
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Mahidol University
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SCOPUS
Bibliographic Citation
British Journal of Haematology. Vol.183, No.3 (2018), 400-410
Suggested Citation
Jan Walewski, Andrzej Hellmann, Noppadol Siritanaratkul, Guner Hayri Ozsan, Muhit Ozcan, Suporn Chuncharunee, Ai Sim Goh, Wojciech Jurczak, Jan Koren, Ewa Paszkiewicz-Kozik, Bingxia Wang, Shalini Singh, Dirk Huebner, Andreas Engert, Bastian von Tresckow Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy. British Journal of Haematology. Vol.183, No.3 (2018), 400-410. doi:10.1111/bjh.15539 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/46230
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Title
Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy
Other Contributor(s)
Hospital Pulau Pinang
Maria Sklodowska-Curie Institute – Oncology Center
Takeda Oncology
Ankara University, Faculty of Medicine
Uniwersytet Jagielloński w Krakowie
Charles University
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Dokuz Eylül Üniversitesi
Gdanski Uniwersytet Medyczny
Faculty of Medicine, Siriraj Hospital, Mahidol University
Uniklinik Köln
Maria Sklodowska-Curie Institute – Oncology Center
Takeda Oncology
Ankara University, Faculty of Medicine
Uniwersytet Jagielloński w Krakowie
Charles University
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Dokuz Eylül Üniversitesi
Gdanski Uniwersytet Medyczny
Faculty of Medicine, Siriraj Hospital, Mahidol University
Uniklinik Köln
Abstract
© 2018 British Society for Haematology and John Wiley & Sons Ltd 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.