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

Autor: Roets E; Department of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands., van der Graaf W; Department of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands; Department of Medical Oncology, ErasmusMC Cancer Institute, Erasmus University Medical Center, Doctor Molewaterplein 40, Rotterdam 3015 GD, the Netherlands., van Riet BHG; Department of Radiotherapy, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands., Haas RL; Department of Radiotherapy, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands; Department of Radiotherapy, Leiden University Medical Center, Albinusdreef 2, Leiden 2333 ZA, the Netherlands., Younger E; Sarcoma Unit, Royal Marsden NHS Foundation Trust, Fulham Road, London SW3 6JJ, United Kingdom., Sparano F; Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy., Wilson R; Sarcoma Patients Advocacy Global Network, Untergasse 36, Wölfersheim D-61200, Germany; Sarcoma UK, 17/18 Angel Gate, City Road, London, UK., van der Mierden S; Scientific information service, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands., Steeghs N; Department of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands., Efficace F; Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy., Husson O; Department of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, the Netherlands; Department of Surgical Oncology, ErasmusMC Cancer Institute, Erasmus University Medical Center, Doctor Molewaterplein 40, Rotterdam 3015 GD, the Netherlands. Electronic address: o.husson@nki.nl.
Jazyk: angličtina
Zdroj: Critical reviews in oncology/hematology [Crit Rev Oncol Hematol] 2024 May; Vol. 197, pp. 104345. Date of Electronic Publication: 2024 Apr 04.
DOI: 10.1016/j.critrevonc.2024.104345
Abstrakt: 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.
Competing Interests: 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.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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