A randomized trial of adjuvant progestagen in early endometrial cancer

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Abstract
A randomized, controlled trial was designed to determine whether adjuvant progestagen therapy improves survival in patients with Stage I or Stage II endometrial cancer. After surgery, 1148 patients were randomly assigned to adjuvant treatment with progesterone or were given no additional therapy. The duration of follow‐up ranged from 42 to 132 months (median follow‐up, 72 months). Crude survival and relapse rates were similar for both groups. Death due to intercurrent disease was higher in the progesterone group (P = 0.04). The median survival of the group of patients with cancer‐related death was higher in the progestagen group than in the control group (30 and 22 months, respectively; P = 0.03). In 461 high‐risk patients, a tendency towards fewer cancer‐related deaths and a better disease‐free survival in the treatment group was observed, but crude survival was unchanged. We conclude that there is little to gain from adjuvant progestagen therapy in patients with low‐risk endometrial cancer, and that further studies are needed in high‐risk patients.