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Multicenter Study
. 2025 Apr;130(4):463-473.
doi: 10.1007/s11547-024-01940-6. Epub 2024 Dec 17.

Ladies project: large database in endometrial cancers for a personalized treatment

Rosa Autorino  1 , Raffaella Michela Rinaldi  2 , Gabriella Macchia  3 , Mariangela Boccardi  3 , Inga Mihoci Roshanian  4 , Rita Sebastiani  4 , Bianca Santo  5 , Donatella Russo  5 , Martina Ferioli  6 , Anna Benini  7 , Elisabetta Perrucci  8 , Arcangela Raguso  9 , Sabrina Cossa  9 , Paolo Matteucci  10 , Claudia Talocco  10 , Lisa Vicenzi  10 , Fabio Trippa  11 , Lorena Draghini  11 , Antonietta Augurio  12 , Fiorella Cristina Di Guglielmo  12 , Paola Cocuzza  13 , Francesca Pistis  14 , Francesca De Felice  15 , Sofia Meregalli  16 , Elisa Maria Bonetto  16 , Maria Tamburo  17 , Vittorio Bini  8 , Andrea Vavassori  18 , Maria Antonietta Gambacorta  1 , Cynthia Aristei  8
Affiliations
Multicenter Study

Ladies project: large database in endometrial cancers for a personalized treatment

Rosa Autorino et al. Radiol Med. 2025 Apr.

Abstract

Purpose: To compare Italian use with current international guidelines and to evaluate oncological outcomes and toxicity patterns of adjuvant radiation therapy (RT) for endometrial cancer (EC) in Italian women.

Materials and methods: To conduct a retrospective multicentre Italian study a large database was set up. Inclusion criteria were: accrual between 2010 and 2020, treatment with surgery, post-operative external beam RT (EBRT) and/or interventional radiotherapy (IRT) associated or not with adjuvant chemotherapy. Oncological outcomes, acute and late toxicities were analysed according to RT schedule and risk group.

Results: A total of 1848 patients, from 16 Italian RT centres were enrolled (median age 65 years, range 27-88). All patients received post-operative RT associated with chemotherapy in 31%. Patients were stratified on the basis of standard risk factors (Bosse et al. in Eur J Cancer 51:1742-50, 2015). After merging intermediate and high-intermediate risk classes into one intermediate group and including advanced and oligometastatic disease in the high-risk group, the low-risk group encompassed 124 patients, the intermediate-risk 1140, and the high risk 576. No low-risk patient developed local relapse (LR). Multivariate analysis showed that intermediate risk patients had a 2.5-fold increased risk of LR if treated with IRT alone vs EBRT-IRT boost. RT schedule did not impact significantly on LR in high risk patients. All acute toxicity parameters were highest in patients who received EBRT with simultaneous integrated boost (EBRT-SIB) and lowest in patients who received only IRT (p < 0.0001). Late toxicity was highest patients who received EBRT-SIB and lowest in those who were given EBRT with sequential boost (p < 0.0001).

Conclusions: This retrospective study showed that Italian administration of adjuvant RT for EC is in accordance with current international guidelines. IRT alone for low-risk patients and EBRT associated with vaginal IRT remain standard adjuvant approaches for EC.

Keywords: Adjuvant treatments; Endometrial cancer; Interventional radiotherapy; Brachytherapy; Radiation therapy; Radiotherapy.

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Conflict of interest statement

Declarations. Conflict of Interest: The authors have no relevant financial or non-financial interests to disclose. Ethical approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Fondazione Policlinico Universitario A. Gemelli IRCSS- Università Cattolica del Sacro Cuore (Date 17.03.2022/No 4793). Informed consent: Author’s number explanation: Ladies Projects is a multi-centre restrospective study and the number of involved hospitals is high (16) as well as the number of enrolled patients (1848) is relevant. Further, the number of authors for each centre has been proportionally assigned according to the number of enrolled patients. For these reasons the number of authors is higher than the allowed number of authors of La Radiologia Medica journal (30 vs 10). All the patients involved gave their informed consent prior to study inclusion.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curves for the local relapse-free survival (a), distant metastasis free survival (b), overall survival (OS) (c) and cancer specific survival (CSS) (d) for all patients (left) and for the three risk group levels (right)
Fig. 2
Fig. 2
Acute (left panel) and late (right panel) toxicity incidence according to radiotherapy treatments. 1: EBRT = External Beam Radiotherapy treatment; 2: BOOST EBRT seq = External Beam Radiotherapy treatment with sequential boost; 3: EBRT + SIB = External Beam Radiotherapy treatment with concomitant boost; 4: EBRT + IRT = External Beam Radiotherapy treatment with Interventional radiotherapy boost; 5: IRT escl. = Interventional radiotherapy
Fig. 3
Fig. 3
Acute toxicity according to radiotherapy treatments. 1: EBRT = External Beam Radiotherapy treatment; 2: BOOST EBRT seq = External Beam Radiotherapy treatment with sequential boost; 3: EBRT + SIB = External Beam Radiotherapy treatment with concomitant boost; 4: EBRT + IRT = External Beam Radiotherapy treatment with Interventional radiotherapy boost; 5: IRT escl. = Interventional radiotherapy
Fig. 4
Fig. 4
Late toxicity (panel a) and vaginal stenosis (panel b) incidence according to radiotherapy treatments. 1: EBRT = External Beam Radiotherapy treatment; 2: BOOST EBRT seq = External Beam Radiotherapy treatment with sequential boost; 3: EBRT + SIB = External Beam Radiotherapy treatment with concomitant boost; 4: EBRT + IRT = External Beam Radiotherapy treatment with Interventional radiotherapy boost; 5: IRT escl. = Interventional radiotherapy
See this image and copyright information in PMC

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