Dermal repeated dose toxicity study of the anti-breast cancer drug Formestane cream in Bama minipig

Shiyao Huang; Ziming Wu; Youyou Chen; Han Li; Linglin Zou; Alexander T Teichmann; Yao Luo; Lifeng Zhang; Lanyang Gao

doi:10.1016/j.fct.2023.113927

Dermal repeated dose toxicity study of the anti-breast cancer drug Formestane cream in Bama minipig

Food Chem Toxicol. 2023 Aug:178:113927. doi: 10.1016/j.fct.2023.113927. Epub 2023 Jul 3.

Authors

Shiyao Huang¹, Ziming Wu¹, Youyou Chen², Han Li¹, Linglin Zou², Alexander T Teichmann², Yao Luo³, Lifeng Zhang⁴, Lanyang Gao⁵

Affiliations

¹ Academician (Expert) Workstation of Sichuan Province, The Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, China; Metabolic Hepatobiliary and Pancreatic Diseases Key Laboratory of Luzhou City, The Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, China.
² Academician (Expert) Workstation of Sichuan Province, The Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, China.
³ Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, China. Electronic address: [email protected].
⁴ Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. Electronic address: [email protected].
⁵ Academician (Expert) Workstation of Sichuan Province, The Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, China; Metabolic Hepatobiliary and Pancreatic Diseases Key Laboratory of Luzhou City, The Affiliated Hospital of Southwest Medical University, Southwest Medical University, Luzhou, China. Electronic address: [email protected].

PMID: 37406756
DOI: 10.1016/j.fct.2023.113927

Abstract

Formestane (4-OHA) has been proven to be highly effective with high systemic tolerability in treating ER⁺ breast cancer. However, its intramuscular administration and associated side effects make it unsuitable for adjuvant treatment, leading to its withdrawal from the market. In contrast, Formestane cream may offer a solution by providing a more convenient route of administration and retaining its tumor-shrinking effects. This suggests that 4-OHA cream could have promising clinical applications. However, before clinical application, it is necessary to evaluate the potential toxicity of the cream in animals. This study evaluated the toxicity of 4-OHA cream on female Bama minipigs in vivo by analyzing hematology, biochemistry, and histopathology. The results showed that there was no significant difference between the cream-treated group and the control normal group for each parameter analyzed, indicating that 4-OHA cream was non-dermal toxic to minipigs. This finding provides a basis for the safe clinical use of the cream.

Keywords: Bama minipig; Dermal toxicity; Formestane cream; Histopathology.

MeSH terms

Androstenedione / adverse effects
Animals
Antineoplastic Agents* / therapeutic use
Female
Neoplasms* / drug therapy
Swine
Swine, Miniature

Substances

formestane
Androstenedione
Antineoplastic Agents