REAL-WORLD PATIENT CHARACTERISTICS AND INITIAL MANAGEMENT STRATEGIES FOR EARLY AND LOCALLY ADVANCED OPERABLE ENDOMETRIAL CANCER IN GREECE: RESULTS OF THE RETROSPECTIVE ‘LAVENDER’ STUDY.

Introduction: In view of the evolving treatment landscape of endometrial cancer (EC) and the shift to a molecular-based recurrence risk classification, real-world data are essential for characterizing patient profiles and enhancing the understanding of risk-stratification algorithms that guide initial management strategies (IMS). Methods: LAVENDER was a multicenter, retrospective, chart review study of patients newly diagnosed with early stage/locally advanced (ES/LA) EC who underwent primary curative surgery (PCS) between 01-Jan-2020 and 31-Dec-2020 (index period) and were disease-free postoperatively. Patients enrolled in clinical trials were excluded. The observation period extended from initial EC diagnosis to the earliest occurrence of first disease recurrence, informed consent or death. Aim: To capture the real-world patient characteristics, IMS and recurrence rate, overall and per physician-determined recurrence risk, among patients diagnosed with ES/LA operable EC during 2020 in Greece. Results: Between Sep-2023 and Jul-2024, 200 patients were consecutively included in the study by Medical Oncologists/Gynecologists across seven hospital clinics, representing 97.1% of all ES/LA EC cases undergoing PCS during the index period. Among evaluable patients, 65.5/11.2/21.8/1.5% had FIGO surgical stage I/II/III/IVA disease (predominantly based on 2018 FIGO staging system), and 77.0% had pure endometrioid carcinoma. Tumor FIGO grade 1/2/3 was documented in 41.2/25.6/33.2% of patients. Physician-determined risk of recurrence was available for 190 patients, with 55.3% (105/190) classified as low, 16.8% (32/190) intermediate, 11.6% (22/190) high-intermediate, and 16.3% (31/190) high risk. Adjuvant treatment was administered to 54.5% (109/200) of patients [radiotherapy only: 28.5%, systemic therapy + radiotherapy: 20.0%, systemic therapy only: 6.0%]. Over a median follow-up of 3.6 years, 14.0% of patients experienced recurrence, a median of 12.7 months post-surgery. Study outcomes per risk of recurrence are shown in the Table. Conclusions: The findings of this study address knowledge gaps and provide insights to guide the future development of treatment strategies for EC, supporting informed healthcare decision-making. Table: Study Outcome Results All patients (N=200) Subgroups per physician-determined risk of EC recurrence Low (N=105) Intermediate (N=32) High-Intermediate (N=22) High (N=31) Duration of observation period (from EC diagnosis) median (IQR), years 3.6 (3.2-4.0) 3.8 (3.5-4.1) 3.6 (3.2-3.9) 3.4 (2.3-3.9) 3.1 (1.3-3.6) Baseline patient and disease characteristics Age at initial EC diagnosis (years) Mean (SD) 63.6 (10.7) 62.4 (10.6) 62.2 (9.2) 67.5 (13.1) 65.7 (9.6) ECOG PS, % (n/N) PS 0 83.6 (112/134) 90.7 (49/54) 85.2 (23/27) 70.6 (12/17) 73.1 (19/26) PS 1 10.4 (14/134) 9.3 (5/54) 3.7 (1/27) 23.5 (4/17) 15.4 (4/26) PS ≥2 6.0 (8/134) 0.0 (0/54) 11.1 (3/27) 5.9 (1/17) 11.5 (3/26) Intraoperative disease staging, % (n/N) Assessed 99.0 (197/199) 99.0 (103/104) 100.0 (32/32) 100.0 (22/22) 100.0 (31/31) FIGO 2018 update 97.8 (176/180) 100.0 (95/95) 96.6 (28/29) 94.4 (17/18) 93.5 (29/31) FIGO Stage IA 38.6 (76/197) 67.0 (69/103) 12.5 (4/32) 4.5 (1/22) 3.2 (1/31) FIGO Stage IB 26.9 (53/197) 20.4 (21/103) 71.9 (23/32) 18.2 (4/22) 9.7 (3/31) FIGO Stage II 11.2 (22/197) 9.7 (10/103) 0.0 (0/32) 40.9 (9/22) 9.7 (3/31) FIGO Stage IIIA 6.6 (13/197) 1.0 (1/103) 3.1 (1/32) 13.6 (3/22) 22.6 (7/31) FIGO Stage IIIB 2.0 (4/197) 0.0 (0/103) 0.0 (0/32) 0.0 (0/22) 12.9 (4/31) FIGO Stage IIIC 13.2 (26/197) 1.9 (2/103) 12.5 (4/32) 22.7 (5/22) 32.3 (10/31) FIGO Stage IVA 1.5 (3/197) 0.0 (0/103) 0.0 (0/32) 0.0 (0/22) 9.7 (3/31) Primary tumor histologic grade, % (n/N) FIGO Grade 1 41.2 (82/199) 64.4 (67/104) 31.3 (10/32) 18.2 (4/22) 3.2 (1/31) FIGO Grade 2 25.6 (51/199) 20.2 (21/104) 43.8 (14/32) 31.8 (7/22) 19.4 (6/31) FIGO Grade 3 33.2 (66/199) 15.4 (16/104) 25.0 (8/32) 50.0 (11/22) 77.4 (24/31) Primary tumor histologic type, % (n/N) Pure endometrioid 77.0 (154/200) 86.7 (91/105) 84.4 (27/32) 81.8 (18/22) 38.7 (12/31) Serous adenocarcinoma 15.5 (31/200) 7.6 (8/105) 9.4 (3/32) 13.6 (3/22) 45.2 (14/31) Other 7.5 (15/200) 5.7 (6/105) 6.3 (2/32) 4.5 (1/22) 16.1 (5/31) Criteria used for the assessment of the risk for EC recurrence among patients with known physician-determined risk of EC recurrence Primary tumor histologic type, % (n/N) 94.2 (179/190) 97.1 (102/105) 90.6 (29/32) 95.5 (21/22) 87.1 (27/31) Disease stage, % (n/N) 93.2 (177/190) 91.4 (96/105) 96.9 (31/32) 90.9 (20/22) 96.8 (30/31) Tumor grade, % (n/N) 88.4 (168/190) 87.6 (92/105) 87.5 (28/32) 90.9 (20/22) 90.3 (28/31) Myometrial invasion status, % (n/N) 79.5 (151/190) 74.3 (78/105) 93.8 (30/32) 86.4 (19/22) 77.4 (24/31) LVSI status, % (n/N) 38.9 (74/190) 34.3 (36/105) 46.9 (15/32) 50.0 (11/22) 38.7 (12/31) Molecular features, % (n/N) 8.4 (16/190) 2.9 (3/105) 6.3 (2/32) 13.6 (3/22) 25.8 (8/31) Patient's age, % (n/N) 6.3 (12/190) 4.8 (5/105) 6.3 (2/32) 4.5 (1/22) 12.9 (4/31) Information on the primary curative surgery for EC Total hysterectomy with bilateral salpingo-oophorectomy, % (n/N) 89.0 (178/200) 88.6 (93/105) 93.8 (30/32) 95.5 (21/22) 87.1 (27/31) Utilization of (neo)adjuvant therapy (ST and/or RT) as part of the initial management strategy of EC No Primary curative surgery only, % (n/N) 45.0 (90/200) 73.3 (77/105) 9.4 (3/32) 4.5 (1/22) 19.4 (6/31) Yes Any(neo)adjuvant therapy (ST and/or RT), % (n/N) 55.0 (110/200) 26.7 (28/105) 90.6 (29/32) 95.5 (21/22) 80.6 (25/31) Adjuvant ST only, % (n/N) 5.5 (11/200) 2.9 (3/105) 3.1 (1/32) 4.5 (1/22) 16.1 (5/31) Adjuvant RT only, % (n/N) 28.5 (57/200) 14.3 (15/105) 68.8 (22/32) 68.2 (15/22) 9.7 (3/31) Adjuvant ST and RT, % (n/N) 20.0 (40/200) 9.5 (10/105) 15.6 (5/32) 22.7 (5/22) 51.6 (16/31) Neoadjuvant ST only, % (n/N) 0.5 (1/200) 0.0 (0/105) 3.1 (1/32) 0.0 (0/22) 0.0 (0/31) Both neoadjuvant and adjuvant ST, % (n/N) 0.5 (1/200) 0.0 (0/105) 0.0 (0/32) 0.0 (0/22) 3.2 (1/31) Type of adjuvant ST administered after the primary curative surgery for EC Administration of adjuvant ST, % (n/N) Yes 26.0 (52/200) 12.4 (13/105) 18.8 (6/32) 27.3 (6/22) 71.0 (22/31) Combination ChT 22.0 (44/200) 8.6 (9/105) 12.5 (4/32) 27.3 (6/22) 64.5 (20/31) Mono ChT 3.5 (7/200) 3.8 (4/105) 6.3 (2/32) 0.0 (0/22) 3.2 (1/31) Combination ChT + TT 0.5 (1/200) 0.0 (0/105) 0.0 (0/32) 0.0 (0/22) 3.2 (1/31) No 74.0 (148/200) 87.6 (92/105) 81.3 (26/32) 72.7 (16/22) 29.0 (9/31) Information on first disease recurrence after primary surgery for EC EC recurrence (confirmed or unconfirmed), % (n/N) 14.0 (28/200) 3.8 (4/105) 9.4 (3/32) 22.7 (5/22) 41.9 (13/31) Time from surgery to first EC recurrence, median (IQR), years 12.7 (9.5-22.4) 15.6 (8.5-31.5) 9.3 (7.8-15.0) 11.1 (9.9-23.7) 16.2 (9.7-28.0) Type of recurrence, % (n/N) Distant 69.2 (18/26) 25.0 (1/4) 66.7 (2/3) 75.0 (3/4) 75.0 (9/12) Local 15.4 (4/26) 50.0 (2/4) 0.0 (0/3) 0.0 (0/4) 16.7 (2/12) Regional 15.4 (4/26) 25.0 (1/4) 33.3 (1/3) 25.0 (1/4) 8.3 (1/12) For variables not following a normal distribution in at least one of the study subpopulations, a uniform presentation of median (IQR) was applied. Abbreviations: ChT, Chemotherapy; EC, Endometrial Cancer; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FIGO, International Federation of Gynecology and Obstetrics system; IQR, Interquartile Range; LVSI, Lymphovascular Space Invasion; n, number of patients with variable; N, number of patients with available data; RT, Radiotherapy; SD, Standard Deviation; ST, Systemic Therapy; TT, Targeted Therapy.