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 S. P Vermaat; Nagesh Kalakonda; Andre Henri Goy; Sylvain Choquet; Eric Van Den Neste; Brian T. Hill; Catherine Thieblemont; Federica Cavallo; Fátima De La Cruz; John Kuruvilla; Nada Hamad; Reda Bouabdallah; Ulrich Jäger; Paolo Caimi; Ronit Gurion; Krzysztof Warzocha; Sameer Bakhshi; Juan Manuel Sancho; Michael Schuster; Miklós Egyed; Fritz Offner; Theodoros P. Vasilakopoulos; Priyanka Samal; Agnes Nagy; Matthew Ku; Miguel Ángel Canales Albendea

doi:10.2217/fon-2020-0946

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 S. P Vermaat
, Nagesh Kalakonda
, Andre Henri Goy
, Sylvain Choquet
, Eric Van Den Neste
, Brian T. Hill
, Catherine Thieblemont
, Federica Cavallo
, Fátima De La Cruz
, John Kuruvilla

Nada Hamad, Reda Bouabdallah, Ulrich Jäger, Paolo Caimi, Ronit Gurion, Krzysztof Warzocha, Sameer Bakhshi, Juan Manuel Sancho, Michael Schuster, Miklós Egyed, Fritz Offner, Theodoros P. Vasilakopoulos, Priyanka Samal, Agnes Nagy, Matthew Ku, Miguel Ángel Canales Albendea

Karyopharm Therapeutics Inc.
Health Economics
Université de Bourgogne
Université libre de Bruxelles
Amsterdam UMC
Cambridge University Hospitals NHS Foundation Trust
Leiden University
University of Liverpool
Hackensack Meridian Health-Hackensack University Medical Center
Sorbonne Université
Université catholique de Louvain
Cleveland Clinic Foundation
Université Paris Cité
University of Turin
Hospital Universitario Virgen del Rocio
Centre of Excellence on Aging and Chronic Diseases of McGill Integrated University Health Network
St. Vincent's Hospital Melbourne
Institut Paoli Calmettes
Medical University of Vienna
UH Cleveland Medical Center
Tel Aviv University
Institute of Hematology and Blood Transfusion
All India Institute of Medical Sciences, New Delhi
Generalitat de Catalunya
Somogy County Kaposi Mór Hospital
Ghent University
National and Kapodistrian University of Athens
Siksha ‘O’ Anusandhan University
Semmelweis University
Hospital Universitario La Paz

Research output: Contribution to journal › Review article › peer-review

10 Scopus citations

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.

Original language	English
Pages (from-to)	1295-1310
Number of pages	16
Journal	Future Oncology
Volume	17
Issue number	11
DOIs	https://doi.org/10.2217/fon-2020-0946
State	Published - Apr 2021

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

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10.2217/fon-2020-0946

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Shah, J., Shacham, S., Kauffman, M., Daniele, P., Tomaras, D., Tremblay, G., Casasnovas, R. O., Maerevoet, M., Zijlstra, J., Follows, G., P Vermaat, J. S., Kalakonda, N., Goy, A. H., Choquet, S., Den Neste, E. V., Hill, B. T., Thieblemont, C., Cavallo, F., La Cruz, F. D., ... Canales Albendea, M. Á. (2021). Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma. Future Oncology, 17(11), 1295-1310. https://doi.org/10.2217/fon-2020-0946

@article{67820fad0e4f425f8da6f1a299c8569a,

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

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",

author = "Jatin Shah and Sharon Shacham and Michael Kauffman and Patrick Daniele and Dimitrios Tomaras and Gabriel Tremblay and Casasnovas, \{Rene Olivier\} and Marie Maerevoet and Josee Zijlstra and George Follows and \{P Vermaat\}, \{Joost S.\} and Nagesh Kalakonda and Goy, \{Andre Henri\} and Sylvain Choquet and \{Den Neste\}, \{Eric Van\} and Hill, \{Brian T.\} and Catherine Thieblemont and Federica Cavallo and \{La Cruz\}, \{F{\'a}tima De\} and John Kuruvilla and Nada Hamad and Reda Bouabdallah and Ulrich J{\"a}ger and Paolo Caimi and Ronit Gurion and Krzysztof Warzocha and Sameer Bakhshi and Sancho, \{Juan Manuel\} and Michael Schuster and Mikl{\'o}s Egyed and Fritz Offner and Vasilakopoulos, \{Theodoros P.\} and Priyanka Samal and Agnes Nagy and Matthew Ku and \{Canales Albendea\}, \{Miguel {\'A}ngel\}",

note = "Publisher Copyright: {\textcopyright} 2021 Patrick Daniele.",

year = "2021",

month = apr,

doi = "10.2217/fon-2020-0946",

language = "English",

volume = "17",

pages = "1295--1310",

journal = "Future Oncology",

issn = "1479-6694",

number = "11",

}

Shah, J, Shacham, S, Kauffman, M, Daniele, P, Tomaras, D, Tremblay, G, Casasnovas, RO, Maerevoet, M, Zijlstra, J, Follows, G, P Vermaat, JS, Kalakonda, N, Goy, AH, Choquet, S, Den Neste, EV, Hill, BT, Thieblemont, C, Cavallo, F, La Cruz, FD, Kuruvilla, J, Hamad, N, Bouabdallah, R, Jäger, U, Caimi, P, Gurion, R, Warzocha, K, Bakhshi, S, Sancho, JM, Schuster, M, Egyed, M, Offner, F, Vasilakopoulos, TP, Samal, P, Nagy, A, Ku, M & Canales Albendea, MÁ 2021, 'Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma', Future Oncology, vol. 17, no. 11, pp. 1295-1310. https://doi.org/10.2217/fon-2020-0946

TY - JOUR

T1 - Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma

AU - Shah, Jatin

AU - Shacham, Sharon

AU - Kauffman, Michael

AU - Daniele, Patrick

AU - Tomaras, Dimitrios

AU - Tremblay, Gabriel

AU - Casasnovas, Rene Olivier

AU - Maerevoet, Marie

AU - Zijlstra, Josee

AU - Follows, George

AU - P Vermaat, Joost S.

AU - Kalakonda, Nagesh

AU - Goy, Andre Henri

AU - Choquet, Sylvain

AU - Den Neste, Eric Van

AU - Hill, Brian T.

AU - Thieblemont, Catherine

AU - Cavallo, Federica

AU - La Cruz, Fátima De

AU - Kuruvilla, John

AU - Hamad, Nada

AU - Bouabdallah, Reda

AU - Jäger, Ulrich

AU - Caimi, Paolo

AU - Gurion, Ronit

AU - Warzocha, Krzysztof

AU - Bakhshi, Sameer

AU - Sancho, Juan Manuel

AU - Schuster, Michael

AU - Egyed, Miklós

AU - Offner, Fritz

AU - Vasilakopoulos, Theodoros P.

AU - Samal, Priyanka

AU - Nagy, Agnes

AU - Ku, Matthew

AU - Canales Albendea, Miguel Ángel

PY - 2021/4

Y1 - 2021/4

N2 - 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.

AB - 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.

KW - EQ-5D-5L

KW - FACT-Lym

KW - diffuse large B-cell lymphoma

KW - disutility of adverse events

KW - health state utility

KW - health utility

KW - health-related quality of life

KW - patient-reported outcomes

KW - selinexor

UR - https://www.scopus.com/pages/publications/85103094087

U2 - 10.2217/fon-2020-0946

DO - 10.2217/fon-2020-0946

M3 - Review article

C2 - 33528286

AN - SCOPUS:85103094087

SN - 1479-6694

VL - 17

SP - 1295

EP - 1310

JO - Future Oncology

JF - Future Oncology

IS - 11

ER -

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

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Keywords

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