title: Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study.
abstract: OBJECTIVE
  Systemic anaplastic large-cell lymphoma (ALCL) is an aggressive subtype of T-cell lymphoma characterized by the uniform expression of CD30. The antibody-drug conjugate brentuximab vedotin delivers the potent antimicrotubule agent monomethylauristatin E to CD30-positive malignant cells. A phase II multicenter trial was conducted to evaluate the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory systemic ALCL.
  
  
  METHODS
  Patients with systemic ALCL and recurrent disease after at least one prior therapy received brentuximab vedotin 1.8 mg/kg intravenously every 3 weeks over 30 minutes as an outpatient infusion. The primary end point of the study was overall objective response rate as assessed by independent central review.
  
  
  RESULTS
  Of 58 patients treated in the study, 50 patients (86%) achieved an objective response, 33 patients (57%) achieved a complete remission (CR), and 17 patients (29%) achieved a partial remission. The median durations of overall response and CR were 12.6 and 13.2 months, respectively. Grade 3 or 4 adverse events in ≥ 10% of patients were neutropenia (21%), thrombocytopenia (14%), and peripheral sensory neuropathy (12%).
  
  
  CONCLUSIONS
  Brentuximab vedotin induced objective responses in the majority of patients and CRs in more than half of patients with recurrent systemic ALCL. Targeted therapy with this CD30-directed antibody-drug conjugate may be an effective treatment for relapsed or refractory systemic ALCL and warrants further studies in front-line therapy.
authors.affiliation: Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111-2497, USA. Barbara.pro@fccc.edu
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.forename: Ranjana
authors.initials: R
authors.lastname: Advani
authors.forename: Pauline
authors.initials: P
authors.lastname: Brice
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Rosenblatt
authors.forename: Tim
authors.initials: T
authors.lastname: Illidge
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Matous
authors.forename: Radhakrishnan
authors.initials: R
authors.lastname: Ramchandren
authors.forename: Michelle
authors.initials: M
authors.lastname: Fanale
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Connors
authors.forename: Yin
authors.initials: Y
authors.lastname: Yang
authors.forename: Eric L
authors.initials: EL
authors.lastname: Sievers
authors.forename: Dana A
authors.initials: DA
authors.lastname: Kennedy
authors.forename: Andrei
authors.initials: A
authors.lastname: Shustov
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000079963:Brentuximab Vedotin; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D017728:Lymphoma, Large-Cell, Anaplastic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D012008:Recurrence; D019233:Retreatment; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D018796:Immunoconjugates; D000079963:Brentuximab Vedotin