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Clinical Trial
. 2021 Apr;17(11):1295-1310.
doi: 10.2217/fon-2020-0946. Epub 2021 Feb 2.

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

Jatin Shah  1 , Sharon Shacham  1 , Michael Kauffman  1 , Patrick Daniele  2 , Dimitrios Tomaras  2 , Gabriel Tremblay  2 , Rene-Olivier Casasnovas  3 , Marie Maerevoet  4 , Josee Zijlstra  5 , George Follows  6 , Joost S P Vermaat  7 , Nagesh Kalakonda  8 , Andre Henri Goy  9 , Sylvain Choquet  10 , Eric Van Den Neste  11 , Brian T Hill  12 , Catherine Thieblemont  13 , Federica Cavallo  14 , Fátima de la Cruz  15 , John Kuruvilla  16 , Nada Hamad  17 , Reda Bouabdallah  18 , Ulrich Jäger  19 , Paolo Caimi  20 , Ronit Gurion  21 , Krzysztof Warzocha  22 , Sameer Bakhshi  23 , Juan Manuel Sancho  24 , Michael Schuster  25 , Miklós Egyed  26 , Fritz Offner  27 , Theodoros P Vasilakopoulos  28 , Priyanka Samal  29 , Agnes Nagy  30 , Matthew Ku  31 , Miguel Ángel Canales Albendea  32
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Free article
Clinical Trial

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

Jatin Shah et al. Future Oncol. 2021 Apr.
Free article

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 disease was both statistically significant and clinically meaningful (mean difference: 0.07; p = 0.001). Conclusion: In patients with relapsed/refractory diffuse large B-cell lymphoma, objective response to selinexor was associated with HRQoL maintenance, reduction in disease-related HRQoL decrements and higher health utilities.

Keywords: EQ-5D-5L; FACT-Lym; diffuse large B-cell lymphoma; disutility of adverse events; health state utility; health utility; health-related quality of life; patient-reported outcomes; selinexor.

Plain language summary

Lay abstract This work examined quality of life (QoL) among patients with relapsed/refractory diffuse large B-cell lymphoma with two to five prior therapies who received single-agent selinexor in the SADAL clinical trial. Analysis of patient-reported Functional Assessment of Cancer Therapy – Lymphoma and EuroQoL five-dimensions five-levels data showed that patients who had objective clinical response to selinexor maintained their QoL over the course of treatment. Grade ≥3 adverse events and serious adverse events were not associated with clinically meaningful negative QoL impacts. Clinical trial registration: NCT02227251 (ClinicalTrials.gov).

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