title: Brentuximab vedotin in transplant-naive patients with relapsed or refractory hodgkin lymphoma: analysis of two phase I studies.
abstract: BACKGROUND
  Brentuximab vedotin is an antibody-drug conjugate designed to selectively deliver monomethyl auristatin E, a microtubule-disrupting agent, to CD30-expressing cells. Brentuximab vedotin induces durable objective responses in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplantation (ASCT). The objective of this post-hoc analysis was to characterize the safety and efficacy of brentuximab vedotin for patients with relapsed or refractory HL who refused or were ineligible for ASCT.
  
  
  METHODS
  This case series included 20 transplant-naïve patients who were enrolled in two phase I multicenter studies. Patients received brentuximab vedotin intravenously every 3 weeks or every week for 3 out of 4 weeks.
  
  
  RESULTS
  The majority of patients were transplant-naïve because of chemorefractory disease. Median age was 31.5 years (range, 12-87 years). Treatment-emergent adverse events in >20% of patients were peripheral neuropathy, fatigue, nausea, pyrexia, diarrhea, weight decreased, anemia, back pain, decreased appetite, night sweats, and vomiting; most events were grade 1 or 2. Six patients obtained objective responses: two complete remissions and four partial remissions. Median duration of response was not met; censored durations ranged from >6.8 to >13.8 months. Three of six responders subsequently received ASCT.
  
  
  CONCLUSIONS
  Brentuximab vedotin was associated with manageable adverse events in transplant-naïve patients with relapsed or refractory HL. The objective responses observed demonstrate that antitumor activity is not limited to patients who received brentuximab vedotin after ASCT. The promising activity observed in this population warrants further study.
authors.affiliation: Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama 35294-3300, USA. andres.forero@ccc.uab.edu
authors.forename: Andres
authors.initials: A
authors.lastname: Forero-Torres
authors.forename: Michelle
authors.initials: M
authors.lastname: Fanale
authors.forename: Ranjana
authors.initials: R
authors.lastname: Advani
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Rosenblatt
authors.forename: Dana A
authors.initials: DA
authors.lastname: Kennedy
authors.forename: Anas
authors.initials: A
authors.lastname: Younes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000079963:Brentuximab Vedotin; D002648:Child; D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects* / Q000627:therapeutic use*; D017730:Ki-1 Antigen / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009842:Oligopeptides / Q000627:therapeutic use*; D033581:Stem Cell Transplantation; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D018796:Immunoconjugates; D017730:Ki-1 Antigen; D009842:Oligopeptides; D000079963:Brentuximab Vedotin; C495575:monomethyl auristatin E