Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma

Scott D. Ramsey, Auayporn Nademanee, Tamas Masszi, Jerzy Holowiecki, Muneer Abidi, Andy Chen, Patrick Stiff, Simonetta Viviani, John W. Sweetenham, John Radford, Yanyan Zhu, Vijayveer Bonthapally, Elizabeth Thomas, Akshara Richhariya, Naomi N. Hunder, Jan Walewski, Craig H. Moskowitz

Research output: Contribution to journalArticle

10 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)860-867
Number of pages8
JournalBritish Journal of Haematology
Volume175
Issue number5
DOIs
StatePublished - Dec 1 2016
Externally publishedYes

Keywords

  • CD30
  • Hodgkin lymphoma
  • autologous-haematopoietic stem cell transplant
  • brentuximab vedotin
  • quality of life

ASJC Scopus subject areas

  • Hematology

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  • Cite this

    Ramsey, S. D., Nademanee, A., Masszi, T., Holowiecki, J., Abidi, M., Chen, A., Stiff, P., Viviani, S., Sweetenham, J. W., Radford, J., Zhu, Y., Bonthapally, V., Thomas, E., Richhariya, A., Hunder, N. N., Walewski, J., & Moskowitz, C. H. (2016). Quality of life results from a phase 3 study of brentuximab vedotin consolidation following autologous haematopoietic stem cell transplant for persons with Hodgkin lymphoma. British Journal of Haematology, 175(5), 860-867. https://doi.org/10.1111/bjh.14316