5. Long term onco-fertility results (secondary endpoint)
Median follow-up after initiation of treatment was 27.8 months (range, 3.2-47.5). At the time of last follow-up, 8 of the 180 patients were lost to follow-up, 1 withdrew the study, 2 received hysterectomy, 3 were still in treatment (1 remained PR and 2 remained SD), and the other 166 women achieved CR (Fig.1). None of the patients experienced PD during treatment. Thirty-four patients remained SD after 7 months of treatment or did not achieve CR after 10 months of treatment. Among these 34 patients, 24 used alternative treatment and the other 10 continued the original regimen.
The median treatment duration to achieve CR were 29.2 weeks (95% CI, 24.4-33.9) in MA group, 19.2 weeks (95%CI, 16.1-21.8) in LNG-IUS group and 25.7 weeks (95%CI, 17.0-34.4) in MA+LNG-IUS group, with no significant statistical difference among the three groups (log-rank P=0.316) (Table 2; Fig.2).
Among the 166 patients who achieved CR, 14 patients recurred during the follow up (Fig.1). The median follow-up after CR was 22.8 months (range, 0.0-44.3). The overall cumulative 1-year and 2-year recurrence rate after CR was 4.6% and 8.6%, without significant difference among the three groups (Fig.3A).
Among the 166 patients who achieved CR, 47 patients planned for parenthood. The pregnancy rate was 76.6% (36/47) in total, 66.7% (12/18) in MA group, 81.3% (13/16) in LNG-IUS group and 84.6% (11/13) in MA+LNG-IUS group without significant statistical difference among groups (Fig.1). Of the 36 women who had a successful pregnancy, 18 had a live birth, 12 had a miscarriage and 6 were still in pregnancy at the last follow up. The cumulative 1-year pregnancy rate after CR was 40.7% in MA group, 37.5% in LNG-IUS group and 38.5% in MA+LNG-IUS group (Fig.3B).