Table 4.
Incident cancers by treatment group in intention to treat population
| Oral E2 plus Vaginal P4 (262 women) | Placebo (264 women) | Proportion Difference | |
|---|---|---|---|
| Total cancer (N women) | 11, 4.2% (2.1%, 7.4%) | 12, 4.5% (2.4%, 7.8%) | −0.3% (−3.8%, 3.1%) |
| Breast cancer | 6, 2.3% (0.8%, 4.9%) | 6, 2.3% (0.8%, 4.9%) | 0% (−2.5%, 2.5%) |
| Colorectal cancer | 3, 1.1% (0.2%, 3.3%) | 1, 0.3% (0%, 2.1%) | −0.8% (−0.7%, 2.3%) |
| Endometrial cancer | 2, 0.8% (0.1%, 2.7%) | 1, 0.4% (0%, 2.1%) | 0.4% (−0.9%, 1.7%) |
| Ovarian cancer | 0, 0% (0%, 1.4%) | 1, 0.4% (0%, 2.1%) | −0.4% (−1.1%, 0.4%) |
| Pancreatic cancer | 0, 0% (0%, 1.4%) | 1, 0.4% (0%, 2.1%) | −0.4% (−1.1%, 0.4%) |
| Stomach cancer | 0, 0% (0%, 1.4%) | 1, 0.4% (0%, 2.1%) | −0.4% (−1.1%, 0.4%) |
| Uterine cancer** | 0, 0% (0%, 1.4%) | 1, 0.4% (0%, 2.1%) | −0.4% (−1.1%, 0.4%) |
| Lung cancer** | 0, 0% (0%, 1.4%) | 1, 0.4% (0%, 2.1%) | −0.4% (−1.1%, 0.4%) |
| Months to first cancer diagnosis, median (IQR) | 40 (34.0–48.0) | 17 (4.5–32.0) | 0.93* |
Data reported as number of women, proportion, 95%confidence interval of proportion
E2=estradiol, P4=progesterone
Log rank test was used to compare the time until the first cancer (in months) by treatment group.
Uterine and lung cancer occurred synchronously within the same participant