Sex-based prognosis in industry-sponsored advanced solid tumour trials: an individual participant data meta-analysis of survival and adverse events
In the largest analysis of IPD from trials supporting FDA drug approvals, we found that females had a 21% lower risk of death and a 16% lower risk of progression, but a 12% higher risk of severe adverse events. These findings highlight the value of the IPD sharing and the importance of sex-stratified evidence for risk stratification, dose optimisation and patient counselling.
Authors
- Nicole M. Kuderer (ORCID: https://orcid.org/0000-0002-9263-8540)
- Lee X. Li (ORCID: https://orcid.org/0000-0001-5259-5198)
- Natansh D. Modi (ORCID: https://orcid.org/0000-0003-3262-5374)
- Ross A. McKinnon (ORCID: https://orcid.org/0000-0002-3725-793X)
- Sina Vatandoust (ORCID: https://orcid.org/0000-0002-4815-0994)
- Rakchha Chhetri (ORCID: https://orcid.org/0000-0003-2474-6547)
- Bradley D. Menz (ORCID: https://orcid.org/0000-0002-0855-5081)
- Ahmad Y. Abuhelwa (ORCID: https://orcid.org/0000-0002-4182-065X)
- G.H. Lyman
- Erik Cornelisse
- Andrew Rowland
- Ashley M Hopkins
- David Postma
- Ganessan Kichenadasse
Institutions
- Flinders University (AU)
- University of South Australia (AU)
- Duke University (US)
- Lake Washington Institute of Technology (US)
- Georgetown University Medical Center (US)
- MedStar Georgetown University Hospital (US)
- Flinders Medical Centre (AU)
- University of Sharjah (AE)
- Fred Hutch Cancer Center (US)
- SA Health (AU)
- Adelaide Institute for Sleep Health (AU)
- Duke Medical Center (US)
- The University of Adelaide (AU)
Publication Details
- Journal
- JNCI Journal of the National Cancer Institute
- Published
- 2026-02-11
- DOI
- https://doi.org/10.1093/jnci/djag046
- Primary Topic
- Sex and Gender in Healthcare
- Type
- article
- Field-Weighted Citation Impact
- 0.00