High dose ketoconazole: endocrine and therapeutic effects in postmenopausal breast cancer
1988

Effects of High Dose Ketoconazole in Postmenopausal Breast Cancer

Sample size: 14 publication Evidence: moderate

Author Information

Author(s): A.L. Harris, B.M.J. Cantwell, M. Dowsett

Primary Institution: University of Newcastle upon Tyne, Department of Clinical Oncology

Hypothesis

Can high dose ketoconazole effectively suppress androgen levels in postmenopausal women with advanced breast cancer?

Conclusion

High dose ketoconazole significantly suppressed testosterone levels in postmenopausal women with advanced breast cancer, but was poorly tolerated.

Supporting Evidence

  • Testosterone levels fell significantly by 37% over a 3 week period.
  • SHBG levels rose over the 3 week period.
  • Two patients on aminoglutethimide showed suppression of testosterone levels with ketoconazole.

Takeaway

This study tested a medicine called ketoconazole to see if it could lower certain hormones in women with breast cancer, but many women had a hard time taking it.

Methodology

The study involved 14 postmenopausal women with advanced breast cancer who were given high doses of ketoconazole and monitored for hormone levels and side effects.

Limitations

The study had a high dropout rate due to gastrointestinal side effects, limiting the assessment of ketoconazole's effectiveness.

Participant Demographics

All participants were postmenopausal women with advanced breast cancer.

Statistical Information

P-Value

0.025

Statistical Significance

p<0.025

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