Oncologic safety and reproductive outcomes of conservative therapy for early-stage endometrial disease

Table 1 Baseline characteristics stratified by diagnosis, n (%)

Variable	AH (n = 126)	G1 EA (n = 108)
Age (years), mean ± SD	30.6 ± 4.6	32.5 ± 4.3
BMI (kg/m2), mean ± SD	27.9 ± 4.4	28.4 ± 5.2
Gravidity (median IQR)	0 (1)	0 (1)
Parity (median IQR)	0 (1)	0 (1)
Infertility	30 (23.8)	28 (25.9)
PCOS	68 (54.0)	49 (45.4)
DM	23 (18.3)	30 (27.8)
HTN	19 (15.1)	19 (17.6)
Lynch syndrome	16 (12.7)	5 (4.6)
Diagnostic method (hysteroscopic)	70 (55.6)	54 (50.0)
ER positive	110 (87.3)	96 (88.9)
PR positive	112 (88.9)	87 (80.6)
Myometrial invasion	2 (1.6)	12 (11.1)
Adnexal masses	5 (4.0)	2 (1.9)
Ki-67 > 20%	37 (29.4)	45 (41.7)
HE4 > 50 pmol/L	28 (22.2)	38 (35.2)
Molecular class: NSMP	98 (77.8)	78 (72.2)
Molecular class: MMRd	16 (12.7)	19 (17.6)
Molecular class: P53abn	5 (4.0)	7 (6.5)
Molecular class: POLEmut	7 (5.6)	4 (3.7)

AH: Atypical hyperplasia; G1 EA: Grade 1 endometrioid adenocarcinoma; BMI: Body mass index; IQR: Interquartile range; PCOS: Polycystic ovary syndrome; DM: Diabetes mellitus; HTN: Hypertension; ER: Estrogen receptor; PR: Progesterone receptor; HE4: Human epididymis protein 4; NSMP: No specific molecular profile; MMRd: Mismatch repair deficient; P53abn: P53 abnormal; POLEmut: POLE-mutated (DNA polymerase epsilon-mutated).

Table 2 Oncologic outcomes, n (%)/mean ± SD

Outcome	Overall (n = 234)	AH (n = 126)	G1 EA (n = 108)	OR (95%CI) G1 EA vs AH
CR rate	187 (79.9)	107 (84.9)	80 (74.1)	0.50 (0.27-0.94)
Time to CR (months)	4.0 ± 1.5	3.8 ± 1.4	4.3 ± 1.6	-
Recurrence rate (of CR)	47 (25.1)	19 (17.8)	28 (35.0)	2.51 (1.25-5.04)
Time to recurrence (months)	11.4 ± 4.6	12.5 ± 5.0	10.5 ± 4.2	-
Definitive surgery	56 (23.9)	23 (18.3)	33 (30.6)	1.97 (1.06-3.65)
Occult disease (of surgery)	14 (25.0)	5 (21.7)	9 (27.3)	1.35 (0.39-4.71)
Follow-up (months)	36.3 ± 13.5	38.0 ± 14.0	34.2 ± 12.8	-
DSS	232 (99.1)	126 (100.0)	106 (98.1)	3.59 (0.14-90.37)
OS	232 (99.1)	126 (100.0)	106 (98.1)	3.59 (0.14-90.37)

AH: Atypical hyperplasia; G1 EA: Grade 1 endometrioid adenocarcinoma; OR: Odds ratio; OS: Overall survival; CI: Confidence interval; CR: Complete response; DSS: Disease-specific survival.

Table 3 Multivariable Cox proportional hazards model for recurrence

Variable	HR	95%CI	P value
Age (per year)	0.99	0.90-1.10	0.920
BMI > 30 (vs ≤ 30)	2.95	1.12-7.76	0.029
Diagnosis (G1 EA vs AH)	1.71	0.66-4.44	0.274
PCOS (yes vs no)	1.19	0.45-3.13	0.729
DM (yes vs no)	1.45	0.47-4.46	0.519
HTN (yes vs no)	0.45	0.10-2.07	0.303
Ki-67 > 20% (vs ≤ 20%)	3.12	1.25-7.81	0.015
HE4 > 50 pmol/L (vs ≤ 50)	2.78	1.10-7.02	0.031

HR: Hazard ratio; CI: Confidence interval; BMI: Body mass index; PCOS: Polycystic ovary syndrome; DM: Diabetes mellitus; HTN: Hypertension; HE4: Human epididymis protein 4.

Table 4 Reproductive outcomes, n (%)

Outcome
ART use	37 (31.6)
Pregnancy achieved	68 (58.1)
Live birth	59 (50.4)
Miscarriage	9 (13.2 of pregnancies)
Ectopic	0 (0)
Obstetric complications	5 (8.5 of live births)
Post-pregnancy hysterectomy	28 (47.5 of live births)

Complete response patients attempting pregnancy, n = 117.