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

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.

Automated summary

Formestane (4-OHA) has been proven effective in treating ER+ breast cancer, but its intramuscular administration and associated side effects make it unsuitable for adjuvant treatment. Formestane cream may offer a convenient solution with retained tumor-shrinking effects, suggesting its promising clinical applications.