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, 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
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.
Source: PubMed