Walewski, Jan ORCID: 0000-0003-4247-2674, Hellmann, Andrzej, Siritanaratkul, Noppadol, Ozsan, Guner Hayri, Ozcan, Muhit, Chuncharunee, Suporn, Goh, Ai Sim, Jurczak, Wojciech ORCID: 0000-0003-1879-8084, Koren, Jan, Paszkiewicz-Kozik, Ewa, Wang, Bingxia, Singh, Shalini, Huebner, Dirk, Engert, Andreas and von Tresckow, Bastian (2018). Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi-agent chemotherapy. Br. J. Haematol., 183 (3). S. 400 - 411. HOBOKEN: WILEY. ISSN 1365-2141

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Abstract

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 center dot 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 center dot 6 months and median duration of CR was 6 center dot 1 months. After a median follow-up of 6 center dot 9 and 16 center dot 6 months, median PFS and OS were 4 center dot 8 months (95% confidence interval, 3 center dot 0-5 center dot 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Walewski, JanUNSPECIFIEDorcid.org/0000-0003-4247-2674UNSPECIFIED
Hellmann, AndrzejUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siritanaratkul, NoppadolUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ozsan, Guner HayriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ozcan, MuhitUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chuncharunee, SupornUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goh, Ai SimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jurczak, WojciechUNSPECIFIEDorcid.org/0000-0003-1879-8084UNSPECIFIED
Koren, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paszkiewicz-Kozik, EwaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wang, BingxiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Singh, ShaliniUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huebner, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engert, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, BastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-166692
DOI: 10.1111/bjh.15539
Journal or Publication Title: Br. J. Haematol.
Volume: 183
Number: 3
Page Range: S. 400 - 411
Date: 2018
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1365-2141
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PHASE-II; MULTICENTER; EFFICACY; SINGLE; UK; GEMCITABINE; NIVOLUMAB; DIAGNOSIS; SAFETY; SGN-35Multiple languages
HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/16669

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