title: Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma post-autologous transplant: meta-analysis versus historical data.
abstract: OBJECTIVE
  This meta-analysis evaluated the antitumor activity of brentuximab vedotin versus historical values in patients with relapsed/refractory Hodgkin lymphoma post-autologous stem cell transplantation (ASCT).
  
  
  METHODS
  A systematic literature review identified studies (1993-February 2013) reporting complete remission (CR) rates in patients with relapsed/refractory Hodgkin lymphoma post-ASCT. Publications reporting CR rates, identified through interrogation of multiple electronic databases and manual searches (with search terms used to capture 'relapsed', 'refractory', 'HL', and 'ASCT'), were included if they reported: ≥20 relapsed/refractory Hodgkin lymphoma patients, where ≥80% were aged ≥12 years and ≥50% had failed prior ASCT. Overall CR rate was determined using a random-effect model, and compared with that reported for brentuximab vedotin in a pivotal phase 2 trial (SG035-0003).
  
  
  METHODS
  Across 17 evaluable studies of historical or experimental agents (n = 812), the estimated overall CR rate was 11.1% (95% confidence interval [CI] 7.0, 17.6; range, 0-38.5%) versus 33.3% (95% CI 25.3, 43.9) for brentuximab vedotin (p < 0.0001). In sensitivity analyses, the estimated overall CR rates for historical/experimental agents were 13.6% (95% CI 8.7, 21.4) when only HL trials that reported a CR rate of >0% were included (13 studies; n = 696; p = 0.0009 vs. brentuximab vedotin), and 9.0% (95% CI 4.9, 16.6) when only HL trials were included where CR definition was reported and was measured using the same criteria as in the SG035-0003 study (12 studies; n = 562; p = 0.0001 vs. brentuximab vedotin).
  
  
  CONCLUSIONS
  Indirect comparisons against a heterogeneous historical sample population naturally limit our ability to draw comparisons, yet the results from this quantitative meta-analysis suggest that the antitumor activity of brentuximab vedotin may exceed that of other therapies used to treat patients with relapsed/refractory Hodgkin lymphoma post-ASCT.
authors.affiliation: Global Outcomes and Epidemiology Research, Millennium: The Takeda Oncology Company , Cambridge, MA , USA.
authors.forename: Vijayveer
authors.initials: V
authors.lastname: Bonthapally
authors.forename: Eric
authors.initials: E
authors.lastname: Wu
authors.forename: Alexander
authors.initials: A
authors.lastname: Macalalad
authors.forename: Hongbo
authors.initials: H
authors.lastname: Yang
authors.forename: Oluwatoyin
authors.initials: O
authors.lastname: Shonukan
authors.forename: Yi
authors.initials: Y
authors.lastname: Liu
authors.forename: Andy
authors.initials: A
authors.lastname: Chi
authors.forename: Dirk
authors.initials: D
authors.lastname: Huebner
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000079963:Brentuximab Vedotin; D006689:Hodgkin Disease / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D012074:Remission Induction / Q000379:methods; D033581:Stem Cell Transplantation / Q000379:methods; D014182:Transplantation, Autologous
chemical_list: D000970:Antineoplastic Agents; D018796:Immunoconjugates; D000079963:Brentuximab Vedotin
keywords: Brentuximab vedotin; Hodgkin lymphoma; Meta-analysis; Remission induction; Stem cell transplantation; Systematic review