1. Many women developed recurrence, most within the first 6 months after cessation of therapy.
2. There were no differences in relapse rate between the 3 treatment arms.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Endometrial cancer is the most common gynecologic malignancy affecting women in the U.S. The primary risk factor is exposure to excess, unopposed estrogen. The most common cause of excess estrogen is endogenous estrogen production from peripheral conversion via aromatase in obese women. Endometrial hyperplasia, the precursor to cancer, is categorized as simple without atypia, complex without atypia, simple with atypia, and complex with atypia. Women with atypical histology are more likely to develop endometrial cancer. Definitive treatment requires hysterectomy. For women who wish to preserve fertility or who do not desire surgical management, they may be treated with progestin therapy in the form of medroxyprogesterone acetate (MPA) or a levonorgestrel-releasing intrauterine device (LNG-IUD). Prior studies have found that the treatment response rate with LNG-IUD is superior to that with oral MPA. Investigations evaluating the rate of relapse after treatment have yielded unclear results. In the present work, authors evaluated recurrence of hyperplasia over 24 months following treatment with LNG-IUD or MPA therapy in a multi-center randomized trial. They found high rates of recurrence but no difference in the rate or timing of relapse between treatment groups.
Strengths of the study included multicenter, randomized controlled trial (RCT) design. The study was limited by small sample size and potential confounding among women who received additional progestin therapy outside of the trial regimen. Further RCTs are needed to identify the optimal duration of therapy and frequency of post-therapy monitoring for women receiving progestin therapy for endometrial hyperplasia.
In-Depth [randomized controlled trial]: This study compared the rate of recurrence of endometrial hyperplasia following treatment among women randomized to receive therapy for 6 months with LNG-IUD (n = 53), 10mg oral MPGA 10 days per cycle (n = 52), and 10mg oral MPA daily (n = 48). The primary outcome of interest was relapse of endometrial hyperplasia as detected by light microscopy.
Of the 135 women completing therapy, 135 had response to therapy. In the 24-month follow-up period, 41% had histological relapse; 63.6% of these relapses occurred within 6 months of cessation of therapy. No differences in relapse were observed between the 3 treatment regimens (p = 0.66). Menopausal status (p = 0.0005) and estrogen level (p = 0.0007) were associated with relapse.
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