FIGURE 1. Flow diagram.
a Patients missed endometrial evaluation at 16 or 32 weeks but reached CR at subsequent endometrial evaluation were excluded for 16 or 32-week CR rate analysis.
b One patient in LNG-IUS group was included in the modified intention-to-treat analysis with no lesions detected at the initial hysteroscopic evaluation.
c Two patients in MA+LNG-IUS group were included in the modified intention-to-treat analysis with no lesions detected at the initial hysteroscopic evaluation. However, one of the them was not included in the safety analyses because MA was not used in the subsequent three months of treatment consolidation.
d In MA group, 2 patients had endometrial hyperplasia and 4 patients had AEH after CR.
e In LNG-IUS group, 2 patients had hyperplasia and 2 patients had AEH after CR.
f In MA+LNG-IUS group, 2 patients had hyperplasia, 1 patient had AEH, and 1 patient developed EC after CR.
Abbreviations: AEH, atypical endometrial hyperplasia; MA, megestrol acetate; LNG-IUS, levonorgestrel-releasing intrauterine system; HSC, hysteroscopy; CR, complete response; PR, partial response; SD, stable disease; EC, endometrial cancer.