Authors: | Horwitz, S. M.; Advani, R. H.; Bartlett, N. L.; Jacobsen, E. D.; Sharman, J. P.; O'Connor, O. A.; Siddiqi, T.; Kennedy, D. A.; Oki, Y. |
Article Title: | Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin |
Abstract: | This phase 2, open-label, multicenter study evaluated the efficacy and safety of brentuximab vedotin, a CD30-directed antibody-drug conjugate, in relapsed/refractory CD30+ non-Hodgkin lymphomas. The primary end point was objective response rate (ORR). Key secondary end points included safety, correlation of CD30 expression with response, response duration, and progression-free survival (PFS). Brentuximab vedotin 1.8 mg/kg was administered every 3 weeks until progression or unacceptable toxicity. This planned subset analysis included patients with peripheral T-cell lymphomas (PTCLs; n = 35), specifically angioimmunoblastic T-cell lymphoma (AITL;E = 13) and PTCL not otherwise specified (n = 22). Median age was 64 years; 63% were refractory to most recent therapy. Of 34 evaluable patients, ORR was 41% (8 complete remissions [CRs], 6 partial remissions [PRs]), and ORR was 54% in AITL (5 CRs, 2 PRs) with median PFS of 6.7 months thus far. No correlation between CD30 expression per central review and response was observed. Safety data were consistent with the known profile of brentuximab vedotin, and included at least grade 3 events of neutropenia (14%), peripheral sensory neuropathy, and hyperkalemia (9% each). In summary, brentuximab vedotin showed antitumor activity in patients with relapsed PTCL particularly AITL. © 2014 by The American Society of Hematology. |
Keywords: | adult; cancer chemotherapy; cancer survival; clinical article; controlled study; protein expression; treatment response; aged; drug activity; neutropenia; cancer recurrence; cancer growth; drug dose reduction; drug efficacy; drug safety; drug withdrawal; treatment duration; cancer patient; progression free survival; drug eruption; multiple cycle treatment; phase 2 clinical trial; sensory neuropathy; pneumocystis pneumonia; antineoplastic activity; drug fever; pneumonia; confusion; hyperkalemia; cancer regression; peripheral t cell lymphoma; t cell lymphoma; multicenter study; brain disease; sepsis; open study; drug blood level; adult respiratory distress syndrome; cd30 antigen; lung edema; angioimmunoblastic t cell lymphoma; brentuximab vedotin; infusion related reaction; human; male; female; priority journal; article |
Journal Title: | Blood |
Volume: | 123 |
Issue: | 20 |
ISSN: | 0006-4971 |
Publisher: | American Society of Hematology |
Date Published: | 2014-05-15 |
Start Page: | 3095 |
End Page: | 3100 |
Language: | English |
DOI: | 10.1182/blood-2013-12-542142 |
PROVIDER: | scopus |
PUBMED: | 24652992 |
PMCID: | PMC4425442 |
DOI/URL: | |
Notes: | Blood -- Cited By (since 1996):1 -- Export Date: 8 July 2014 -- CODEN: BLOOA -- Source: Scopus |