Health-related quality of life analysis in ovarian cancer clinical trials involving PARP inhibitors: a critical methodological perspective

The poly (ADP-ribose) polymerase inhibitors (PARPi) have yielded significant clinical benefits as maintenance therapy in women with newly diagnosed and relapsed platinum-sensitive advanced ovarian cancer. These drugs were approved based on progression-free survival, the primary endpoint of their res...

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Vydáno v:Quality of Life Research Ročník 31; číslo 12; s. 3331 - 3337
Hlavní autoři: Fiteni, Frédéric, Péron, Julien
Médium: Journal Article
Jazyk:angličtina
japonština
Vydáno: Cham Springer Science and Business Media LLC 01.12.2022
Springer International Publishing
Springer Nature B.V
Springer Verlag
Témata:
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Adenosine Diphosphate
Clinical trials
Commentary
Female
Health-related quality of life
Humans
Life Sciences
Medicine
Medicine & Public Health
MESH: Adenosine Diphosphate
MESH: Female
MESH: Humans
MESH: Ovarian Neoplasms
MESH: Poly(ADP-ribose) Polymerase Inhibitors
MESH: Quality of Life
MESH: Ribose
Ovarian cancer
Ovarian Neoplasms
PARP inhibitor
Poly(ADP-ribose) Polymerase Inhibitors
Public Health
Quality of Life
Quality of Life Research
Ribose
Santé publique et épidémiologie
Sociology
Statistical analysis
Targeted cancer therapy
Health-related quality of life
Statistical analysis
PARP inhibitor
Ovarian cancer
ISSN:0962-9343, 1573-2649, 1573-2649
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Shrnutí:The poly (ADP-ribose) polymerase inhibitors (PARPi) have yielded significant clinical benefits as maintenance therapy in women with newly diagnosed and relapsed platinum-sensitive advanced ovarian cancer. These drugs were approved based on progression-free survival, the primary endpoint of their respective pivotal trials. Health-related quality of life (HRQoL) and/or patient-reported outcomes were included in these trials as a secondary exploratory endpoint. Nevertheless, many weaknesses in the analysis of HRQoL across these trials can be noticed. Heterogeneity and suboptimal HRQoL analysis in oncology trials contribute to misconceptions about this endpoint among oncologists and prevent quality of life as being an endpoint used for approvals. In this article, we discuss these HRQoL results from a methodological perspective and propose some solutions for improvement that could be used by regulatory and academic institutions running ovarian cancers trials. Notably, we suggest to measure and analyze HRQoL data after disease progression, to focus dedicated papers on the statistical analyses of HRQoL recommended by the SISAQOL consortium (linear mixed model for repeated measures and time-to-event approaches) and to communicate on available guidelines to ensure compliance with best international practices regarding the measurement and analysis of HRQoL.
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ISSN:0962-9343
1573-2649
1573-2649
DOI:10.1007/s11136-022-03193-0