Outcome differences by sex in oncology clinical trials.

Autor: Kammula AV; Cancer Data Science Laboratory, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA., Schäffer AA; Cancer Data Science Laboratory, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA. alejandro.schaffer@nih.gov., Rajagopal PS; Cancer Data Science Laboratory, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA.; Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA., Kurzrock R; WIN Consortium and Medical College of Wisconsin, Milwaukee, WI 53226 and University of Nebraska, Omaha, NE, 68198, USA., Ruppin E; Cancer Data Science Laboratory, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA. eytan.ruppin@nih.gov.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2024 Mar 23; Vol. 15 (1), pp. 2608. Date of Electronic Publication: 2024 Mar 23.
DOI: 10.1038/s41467-024-46945-x
Abstrakt: Identifying sex differences in outcomes and toxicity between males and females in oncology clinical trials is important and has also been mandated by National Institutes of Health policies. Here we analyze the Trialtrove database, finding that, strikingly, only 472/89,221 oncology clinical trials (0.5%) had curated post-treatment sex comparisons. Among 288 trials with comparisons of survival, outcome, or response, 16% report males having statistically significant better survival outcome or response, while 42% reported significantly better survival outcome or response for females. The strongest differences are in trials of EGFR inhibitors in lung cancer and rituximab in non-Hodgkin's lymphoma (both favoring females). Among 44 trials with side effect comparisons, more trials report significantly lesser side effects in males (N = 22) than in females (N = 13). Thus, while statistical comparisons between sexes in oncology trials are rarely reported, important differences in outcome and toxicity exist. These considerable outcome and toxicity differences highlight the need for reporting sex differences more thoroughly going forward.
(© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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