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Clinical Trial
. 2021 Aug;17(22):2923-2939.
doi: 10.2217/fon-2021-0284. Epub 2021 Apr 15.

Health-related quality of life and pain with selinexor in patients with advanced dedifferentiated liposarcoma

Mrinal Gounder  1 , Albiruni R Abdul Razak  2 , Adrienne M Gilligan  3 , Hoyee Leong  3 , Xiwen Ma  3 , Neeta Somaiah  4 , Sant P Chawla  5 , Javier Martin-Broto  6 , Giovanni Grignani  7 , Scott M Schuetze  8 , Bruno Vincenzi  9 , Andrew J Wagner  10 , Bartosz Chmielowski  11 , Robin L Jones  12 , Jatin Shah  3 , Sharon Shacham  3 , Michael Kauffman  3 , Richard F Riedel  13 , Steven Attia  14
Affiliations
Clinical Trial

Health-related quality of life and pain with selinexor in patients with advanced dedifferentiated liposarcoma

Mrinal Gounder et al. Future Oncol. 2021 Aug.

Abstract

Objective: Compare health-related quality of life (HRQoL) of selinexor versus placebo in patients with dedifferentiated liposarcoma. Materials & methods: HRQoL was assessed at baseline and day 1 of each cycle using the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire. Results were reported from baseline to day 169 (where exposure to treatment was maximized while maintaining adequate sample size). Results: Pain scores worsened for placebo versus selinexor across all postbaseline visits, although differences in HRQoL at some visits were not significant. Other domains did not exhibit significant differences between arms; however, scores in both arms deteriorated over time. Conclusion: Patients treated with selinexor reported lower rates and slower worsening of pain compared with patients who received placebo.

Keywords: advanced liposarcoma; pain; patient-reported outcomes; progression-free survival; quality of life; selective inhibitor of nuclear export; selinexor.

Plain language summary

Lay abstract The goal of this study was to compare the health-related quality of life (HRQoL) of patients with advanced unresectable dedifferentiated liposarcoma treated with selinexor compared with those treated with placebo. HRQoL was measured prior to treatment initiation and at the first day of each cycle of their treatment using the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire. Pain scores worsened for placebo compared with selinexor across all visits after treatment, but differences at some visits were not significant. Other domains did not exhibit significant differences between arms; however, scores in both arms worsened over time reflecting the progressive disease burden in this patient population. As pain is one of the most devastating symptoms associated with advanced and progressing cancers, the significant reduction in pain in the selinexor arm, according to patient perception, represent a relevant added value of this drug in dedifferentiated liposarcoma.

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Figures

Figure 1.
Figure 1.. Model-based change from baseline on European Organization for Research and Treatment of Cancer quality of life-30 item questionnaire.
QoL: Quality of life.
Figure 2.
Figure 2.. Time to definitive deterioration on European Organization for Research and Treatment of Cancer quality of life pain score.
See this image and copyright information in PMC

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