| Serious adverse event | Estradiol 6 mg/day (n = 34) | Estradiol 30 mg/day (n = 32) | ||
|---|---|---|---|---|
| n | % | n | % | |
| Nausea/vomiting | 0 | 0.0 | 5 | 15.6 |
| Hyponatremia | 1 | 2.9 | 5 | 15.6 |
| Pleural effusion | 0 | 0.0 | 4 | 12.5 |
| Pain | 6 | 17.6 | 4 | 12.5 |
| Thrombosis/embolism | 1 | 2.9 | 1 | 3.1 |
| Brain ischemia | 1 | 2.9 | 0 | 0.0 |
| Infection | 2 | 5.9 | 3 | 9.4 |
| Hypercalcemia | 0 | 0.0 | 2 | 6.3 |
| Other | 6 | 17.6 | 10 | 31.3 |
| Summary: Side effects in a small phase 2 study of women with metastatic breast cancer randomized to receive either 6 or 30 mg/day of oral estradiol as therapy. "The adverse event rate (≥grade 3) in the 30-mg group (11/32 [34%]; 95% confidence interval [CI], 23%-47%) was higher than in the 6-mg group (4/34 [18%]; 95% CI, 5%-22%; p=0.03). Clinical benefit rates were 9 of 32 (28%; 95% CI, 18%-41%) in the 30-mg group and 10 of 34 (29%; 95% CI, 19%-42%) in the 6-mg group." Sources: [1] | ||||
Template documentationReferences
- ^ [non-primary source needed] Ellis MJ, Gao F, Dehdashti F, Jeffe DB, Marcom PK, Carey LA, Dickler MN, Silverman P, Fleming GF, Kommareddy A, Jamalabadi-Majidi S, Crowder R, Siegel BA (August 2009). "Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study". JAMA. 302 (7): 774–80. doi:10.1001/jama.2009.1204. PMC 3460383. PMID 19690310.