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Aktuelle Urol
DOI: 10.1055/a-2510-9757
Übersicht

Geschlechtsspezifische Unterschiede in uro-onkologischen Studien

Gender-/Sex-Specific Differences in Clinical Trials in Uro-Oncology
Marie Christine Roesch
1   Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany
,
Lea Sophie Lütje
1   Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany
,
Nils Gilbert
1   Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany
,
Axel Stuart Merseburger
1   Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany
,
Daniar Osmonov
1   Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany
› Author AffiliationsSupported by: Universität zu Lübeck Roesch MC: Lübecker Advanced Clinical Scientist
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Zusammenfassung

Obwohl Subgruppenanalysen in klinischen Studien teilweise geschlechtsspezifische Unterschiede in den Ergebnissen aufweisen, gibt es nur selten eine Zulassungsbeschränkung auf nur ein Geschlecht oder geschlechtsangepasste Dosierungsempfehlungen. Außerdem sind Differenzen in den geschlechtsspezifischen Studieneinschlussraten im Vergleich zu den jeweiligen Inzidenz- oder Prävalenzraten wahrzunehmen. Der folgende Artikel beleuchtet geschlechtsspezifische Unterschiede in uro-onkologischen klinischen Studien.

Abstract

Subgroup analyses in clinical trials sometimes reveal gender-/sex-dependent differences in cancer outcomes. However, drug approvals are rarely restricted to a specific sex or gender, and recommendations regarding dosage are rarely tailored accordingly. Furthermore, discrepancies exist between the gender-/sex-dependent enrollment rates in clinical trials and real-world incidence or mortality rates. This article highlights gender-/sex differences in clinical trials in uro-oncology.

Schlüsselwörter

klinische Studien - Uro-Onkologie - Geschlecht - Studienraten

Keywords

clinical trials - uro-oncology - gender - sex - enrollment in clinical trials


Publication History

Received: 28 August 2024

Accepted after revision: 18 December 2024

Article published online:
28 January 2025

© 2025. Thieme. All rights reserved.

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  • Literatur

  • 1 Vfa-Positionspapier „Berücksichtigung von Frauen und Männern bei der Arzneimittelforschung“. Vfa. Die forschenden Pharmaunternehmen. Accessed April 05, 2024 at: https://www.vfa.de/embed/positionspapier-beruecksichtigung-von-frauen-und-maennern-bei-der-arzneimittelforschung.pdf-1
    PubMed
  • 2 Global Cancer Obervatory. International Agency for Research on Cancer und World Health Organization. Accessed April 05, 2024 at: https://gco.iarc.fr/en
    PubMed
  • 3 Robert Koch-Institut (Hrsg.), Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. (Hrsg.). Krebs in Deutschland für 2019/2020. 14. Ausgabe. Berlin: 2023
    Search in Google Scholar
  • 4 Rosiello G, Pecoraro A, Deuker M. et al. The impact of sex and age on distribution of metastases in patients with renal cell carcinoma. Int J Clin Oncol 2021; 26: 962-970
    CrossrefPubMedSearch in Google Scholar
  • 5 Rosiello G, Palumbo C, Deuker M. et al. Sex- and age-related differences in the distribution of bladder cancer metastases. Jpn J Clin Oncol 2021; 51: 976-983
    CrossrefPubMedSearch in Google Scholar
  • 6 Mariotti A, Spatafora P, Sessa F. et al. Gender and cystectomy for bladder cancer: A high-volume tertiary urologic care center experience. Eur J Surg Oncol 2023; 49: 107034
    CrossrefPubMedSearch in Google Scholar
  • 7 O'Malley RL, Underwood 3rd W, Brewer KA. et al. Gender disparity in kidney cancer treatment: women are more likely to undergo radical excision of a localized renal mass. Urology 2013; 82: 1065-1069
    CrossrefPubMedSearch in Google Scholar
  • 8 Fender AC, Dobrev D. Geschlechtsspezifische Unterschiede in der Pharmakologie. Aktuelle Kardiologie 2022; 11: 62-66
    Thieme ConnectPubMedSearch in Google Scholar
  • 9 Thürmann PA. Geschlechtsspezifische Unterschiede in der Pharmakokinetik und -dynamik von Arzneimitteln. Bundesgesundheitsbl – Gesundheitsf – Gesundheitsschutz 2005; 48: 536-540
    CrossrefPubMedSearch in Google Scholar
  • 10 Unger JM, Vaidya R, Albain KS. et al. Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials. J Clin Oncol 2022; 40: 1474-1486
    CrossrefPubMedSearch in Google Scholar
  • 11 Yuan Y, Liu L, Chen H. et al. Comprehensive Characterization of Molecular Differences in Cancer between Male and Female Patients. Cancer Cell 2016; 29: 711-722
    CrossrefPubMedSearch in Google Scholar
  • 12 Ma J, Malladi S, Beck AH. Systematic Analysis of Sex-Linked Molecular Alterations and Therapies in Cancer. Sci Rep 2016; 6: 19119
    CrossrefPubMedSearch in Google Scholar
  • 13 Dymanus KA, Butaney M, Magee DE. et al. Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study. Cancer 2021; 127: 3156-3162
    CrossrefPubMedSearch in Google Scholar
  • 14 Mendis S, Anand S, Karasinska JM. et al. Sex Representation in Clinical Trials Associated with FDA Cancer Drug Approvals Differs Between Solid and Hematologic Malignancies. Oncologist 2021; 26: 107-114
    CrossrefPubMedSearch in Google Scholar
  • 15 Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Department of Health and Human Services – Food and Drug Administration: Federal Register, Vol. 58, No. 139, July 22. 1993
    PubMedSearch in Google Scholar
  • 16 Powles T, Park SH, Voog E. et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2020; 383: 1218-1230
    CrossrefPubMedSearch in Google Scholar
  • 17 Powles T, Rosenberg JE, Sonpavde GP. et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med 2021; 384: 1125-1135
    CrossrefPubMedSearch in Google Scholar
  • 18 Motzer RJ, Tannir NM, McDermott DF. et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med 2018; 378: 1277-1290
    CrossrefPubMedSearch in Google Scholar
  • 19 Rini BI, Escudier B, Tomczak P. et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011; 378: 1931-1939
    CrossrefPubMedSearch in Google Scholar