Journal article

Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma

Jatin Shah, Sharon Shacham, Michael Kauffman, Patrick Daniele, Dimitrios Tomaras, Gabriel Tremblay, Rene-Olivier Casasnovas, Marie Maerevoet, Josee Zijlstra, George Follows, Joost SP Vermaat, Nagesh Kalakonda, Andre Henri Goy, Sylvain Choquet, Eric Van den Neste, Brian T Hill, Catherine Thieblemont, Federica Cavallo, Fatima de la Cruz, John Kuruvilla Show all

FUTURE ONCOLOGY | FUTURE MEDICINE LTD | Published : 2021

Abstract

Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT) - Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Results: Treatment responders maintained higher FACT - Lymphoma (p ≤ 0.05), FACT - General (p < 0.05) and EuroQoL five-dimensions five-levels index scores (p < 0.001) beginning in cycle 3. The estimated difference in health state utilities for treatment response and progressive d..

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Funding Acknowledgements

This work was funded by Karyopharm Therapeutics. P Daniele, D Tomaras and G Tremblay are employees of Purple Squirrel Economics, which received funding from Karyopharm Therapeutics to conduct the analysis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance was provided by N Vurgun and K Sandman, who are employees of Purple Squirrel Economics. The authors are fully responsible for all content and editorial decisions in this manuscript. This study was performed in compliance with the ethical principles that originate from the Declaration of Helsinki and are consistent with International Council for Harmonisation guidelines on Good Clinical Practice and regulatory requirements as applicable. The study protocol was approved by the institutional review board or an independent ethics committee at each study center. Written informed consent in accordance with federal, local and institutional guidelines was obtained from all patients. The authors certify that this manuscript reports secondary analysis of clinical trial data that was shared with them, and that the use of this shared data is in accordance with the terms agreed upon their receipt. The source of this data is NCT02227251 (Karyopharm Therapeutics). This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.