title: Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma.
abstract: Brentuximab vedotin (BV) significantly improved progression-free survival in a phase 3 study in patients with relapsed or refractory Hodgkin lymphoma (RR-HL) post-autologous-haematopoietic stem cell transplant (auto-HSCT); we report the impact of BV on quality of life (QOL) from this trial. The European Quality of Life five dimensions questionnaire was administered at the beginning of each cycle, end of treatment, and every 3 months during follow-up; index value scores were calculated using the time trade-off (TTO) method for UK-weighted value sets. Questionnaire adherence during the trial was 87·5% (N = 329). In an intent-to-treat analysis, compared with placebo, TTO scores in the BV arm did not exceed the minimally important difference (MID) of 0·08 except at month 15 (-0·084; 95% confidence interval, -0·143 to -0·025). On-treatment index scores were similar between arms and did not reach the MID at any time point; mixed-effect modelling showed that BV treatment effect was not significant (P = 0·2127). BV-associated peripheral neuropathy did not meaningfully impact QOL. Utility scores for patients who progressed declined compared with those who did not; TTO scores between these patients exceeded the MID beginning at month 15. In conclusion, QOL decreased modestly with BV consolidation treatment in patients with RR-HL at high risk of relapse after auto-HSCT.
authors.affiliation: Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Ramsey
authors.affiliation: City of Hope National Medical Center, Duarte, CA, USA.
authors.forename: Auayporn
authors.initials: A
authors.lastname: Nademanee
authors.affiliation: Haematology & Stem Cell Department, Szent Istvan & Szent Laszlo Corporate Hospital, Budapest, Hungary.
authors.forename: Tamas
authors.initials: T
authors.lastname: Masszi
authors.affiliation: Department of Bone Marrow Transplantation & Oncohaematology, Maria Sklodowska-Curie Institute of Oncology, Gliwice, Poland.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Holowiecki
authors.affiliation: Spectrum Health Cancer Center, Michigan State University, Grand Rapids, MI, USA.
authors.forename: Muneer
authors.initials: M
authors.lastname: Abidi
authors.affiliation: Oregon Health & Science University, Portland, OR, USA.
authors.forename: Andy
authors.initials: A
authors.lastname: Chen
authors.affiliation: Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Stiff
authors.affiliation: Istituto Nazionale dei Tumori, Milano, Italy.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Viviani
authors.affiliation: Huntsman Cancer Institute, University of Utah Health Care, Salt Lake City, UT, USA.
authors.forename: John W
authors.initials: JW
authors.lastname: Sweetenham
authors.affiliation: University of Manchester and Christie NHS Foundation Trust, Manchester, UK.
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.affiliation: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
authors.forename: Yanyan
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
authors.forename: Vijayveer
authors.initials: V
authors.lastname: Bonthapally
authors.affiliation: Seattle Genetics, Inc., Bothell, WA, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Thomas
authors.affiliation: Seattle Genetics, Inc., Bothell, WA, USA.
authors.forename: Akshara
authors.initials: A
authors.lastname: Richhariya
authors.affiliation: Seattle Genetics, Inc., Bothell, WA, USA.
authors.forename: Naomi N
authors.initials: NN
authors.lastname: Hunder
authors.affiliation: Maria Sklodowska-Curie Institute and Institute of Oncology, Warsaw, Poland.
authors.forename: Jan
authors.initials: J
authors.lastname: Walewski
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Craig H
authors.initials: CH
authors.lastname: Moskowitz
mesh_terms: D064592:Autografts; D000079963:Brentuximab Vedotin; D060830:Consolidation Chemotherapy; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods* / Q000523:psychology; D006689:Hodgkin Disease / Q000523:psychology / Q000628:therapy*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use*; D011788:Quality of Life; D016879:Salvage Therapy / Q000379:methods; D011795:Surveys and Questionnaires
chemical_list: D018796:Immunoconjugates; D000079963:Brentuximab Vedotin
keywords: CD30; Hodgkin lymphoma; autologous-haematopoietic stem cell transplant; brentuximab vedotin; quality of life