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; n = 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. This trial was registered at www.clinicaltrials.gov as #NCT01421667.
authors.affiliation: Department of Medicine, Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, NY;
authors.forename: Steven M
authors.initials: SM
authors.lastname: Horwitz
authors.affiliation: Department of Medicine, Oncology Division, Stanford University Medical Center, Stanford, CA;
authors.forename: Ranjana H
authors.initials: RH
authors.lastname: Advani
authors.affiliation: Department of Internal Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO;
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA;
authors.forename: Eric D
authors.initials: ED
authors.lastname: Jacobsen
authors.affiliation: US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR;
authors.forename: Jeff P
authors.initials: JP
authors.lastname: Sharman
authors.affiliation: Center for Lymphoid Malignancies, Department of Medicine, Columbia University Medical Center/New York Presbyterian Hospital, New York, NY;
authors.forename: Owen A
authors.initials: OA
authors.lastname: O'Connor
authors.affiliation: Department of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA;
authors.forename: Tanya
authors.initials: T
authors.lastname: Siddiqi
authors.affiliation: Seattle Genetics, Inc., Bothell, WA; and.
authors.forename: Dana A
authors.initials: DA
authors.lastname: Kennedy
authors.affiliation: Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Oki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000079963:Brentuximab Vedotin; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017730:Ki-1 Antigen / Q000032:analysis; D016399:Lymphoma, T-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology
chemical_list: D018796:Immunoconjugates; D017730:Ki-1 Antigen; D000079963:Brentuximab Vedotin