Version 1
: Received: 23 October 2024 / Approved: 23 October 2024 / Online: 24 October 2024 (10:10:46 CEST)
How to cite:
Lyons, C. E.; Jin, R.; Smith, A. D.; Zhu, H.; Slingluff, Jr, C. L. Adverse Events as a Function of Biologic Sex in a Multicenter Clinical Trial of Melanoma Vaccines. Preprints2024, 2024101881. https://doi.org/10.20944/preprints202410.1881.v1
Lyons, C. E.; Jin, R.; Smith, A. D.; Zhu, H.; Slingluff, Jr, C. L. Adverse Events as a Function of Biologic Sex in a Multicenter Clinical Trial of Melanoma Vaccines. Preprints 2024, 2024101881. https://doi.org/10.20944/preprints202410.1881.v1
Lyons, C. E.; Jin, R.; Smith, A. D.; Zhu, H.; Slingluff, Jr, C. L. Adverse Events as a Function of Biologic Sex in a Multicenter Clinical Trial of Melanoma Vaccines. Preprints2024, 2024101881. https://doi.org/10.20944/preprints202410.1881.v1
APA Style
Lyons, C. E., Jin, R., Smith, A. D., Zhu, H., & Slingluff, Jr, C. L. (2024). Adverse Events as a Function of Biologic Sex in a Multicenter Clinical Trial of Melanoma Vaccines. Preprints. https://doi.org/10.20944/preprints202410.1881.v1
Chicago/Turabian Style
Lyons, C. E., Hong Zhu and Craig L Slingluff, Jr. 2024 "Adverse Events as a Function of Biologic Sex in a Multicenter Clinical Trial of Melanoma Vaccines" Preprints. https://doi.org/10.20944/preprints202410.1881.v1
Abstract
Background/Objective: Biological females experience more autoimmune disease than males and more treatment-related adverse events (TRAEs) after immune checkpoint blockade therapy. However, little is known about sex-related differences in TRAEs after cancer vaccines.
Methods: The Mel44 clinical trial (NCT00118274) enrolled patients with high-risk melanoma to either of two melanoma vaccines. We hypothesized that females would experience higher rates and grades of TRAEs. TRAE rates and grades were compared between sexes, with adjustment for multiple comparisons, and with mixed-effects models.
Results: Multiple sex-related differences in TRAE rate and grade were observed in unadjusted comparisons, but only hyperglycemia and hypopigmentation were significantly higher grade by sex after correcting for multiple comparisons: they were increased in males. In mixed-effect mod-els, vaccination strategy, but not patient sex, was independently associated with TRAE rates and grades. Conclusions: These data do not support our hypothesis that TRAEs would be increased in females. Vaccine safety was supported for both males and females.
Medicine and Pharmacology, Oncology and Oncogenics
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
