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. 2024 May:197:104345.
doi: 10.1016/j.critrevonc.2024.104345. Epub 2024 Apr 4.

Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review

Evelyne Roets  1 , Winette van der Graaf  2 , Bauke H G van Riet  3 , Rick L Haas  4 , Eugenie Younger  5 , Francesco Sparano  6 , Roger Wilson  7 , Stevie van der Mierden  8 , Neeltje Steeghs  1 , Fabio Efficace  6 , Olga Husson  9
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Free article

Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review

Evelyne Roets et al. Crit Rev Oncol Hematol. 2024 May.
Free article

Abstract

Background: This systematic review evaluates reporting of patient-reported outcomes (PROs) within randomized clinical trials (RCTs) for advanced soft tissue sarcoma (STS) patients.

Methods: A systematic literature search from January 2000 - August 2022 was conducted for phase II/III RCTs evaluating systemic treatments in adult patients with advanced STS. Quality of PRO reporting was assessed using the CONSORT PRO extension.

Results: Out of 7294 abstracts, 59 articles were included; comprising 43 RCTs. Only 15 RCTs (35%) included PROs, none as primary endpoints. Only 10 of these RCTs reported PROs, either in the primary (6/10) or secondary publication (1/10) or in both (3/10), with a median time interval of 23 months. The median CONSORT PRO adherence score was 5.5/14, with higher scores in publications focusing exclusively on PROs.

Conclusion: These results highlight the need for improved and more consistent PRO reporting to inform patient care in the setting of advanced STS.

Keywords: Health-related quality of Life (HRQoL); Patient-reported outcomes (PROs); Randomized clinical trial (RCT); Soft tissue sarcoma (STS); Systemic therapy.

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Conflict of interest statement

Declaration of Competing Interest F. Efficace had a consultancy or advisory role for AbbVie, Incyte, Syros, Novartis and JAZZ Pharmaceuticals, outside the submitted work. W. van der Graaf: Advisory boards SpringworkTx, Agenus and PTC Therapeutics (all to the institute) and research grants from Eli Lilly (to the Institute). N. Steeghs: N. Steeghs provided consultation or attended advisory boards for Boehringer Ingelheim, Ellipses Pharma. N Steeghs received research grants for the institute from AB Science, Abbvie, Actuate Therapeutics, ADCtherapeutics, Amgen, Array, Ascendis Pharma, Astex, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, BridgeBio, Bristol-Myers Squibb, Cantargia, Celgene, CellCentric, Cresecendo, Cytovation, Deciphera, Eli Lilly, Exelixis, Genentech, Genmab, Gilead, GlaxoSmithKline, Incyte, InteRNA, Janssen/Johnson&Johnson, Kinate, Merck, Merck Sharp & Dohme, Merus, Molecular Partners, Novartis, Numab, Pfizer, Pierre Fabre, Regeneron, Roche, Sanofi, Seattle Genetics, Servier, Taiho, Takeda (outside the submitted work). All remaining authors have declared no conflicts of interest.

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