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.