An Observational Study of Molecular profIling of Advanced and aggRessive ENdometrial Cancer and 1-st Line Treatment Approaches in Russian Federation

The rate of Mutation in the exonuclease domain of the Deoxyribonucleic Acid polymerase epsilon (POLE) gene positive status (i.e. detection of pathological variant(s) by Next-Generation Sequencing /Polymerase Chain Reaction), overall and by each variant;

The rate of Mismatch Repair Deficiency status and Mismatch Repair Proficiency status detected by Immunohistochemistry and by combined approach of molecular classification;

The rate of Abnormal expression of p53 protein positive status detected by Immunohistochemistry and by combined approach of molecular classification;

The rate of Programmed Cell Death Ligand 1 positive status (Tumor Area Positivity ≥1%) detected by Immunohistochemistry;

The rate of HER2 expression 3+ detected by Immunohistochemistry according to American Society of Clinical Oncology College of American Pathologists (ASCO CAP) gastric cancer and ASCO CAP guidelines for HER2 testing in Endometrial cancer, and proportion of patients with each result of Immunohistochemistry score (0, 1+, 2+, 3+) on each of the two criteria of evaluation and relationship between them.

Proportion of patients received any 1st line systemic (postoperative) chemotherapy, overall and by each regimen/drug;

Duration of the 1st line systemic (postoperative) chemotherapy (months), No. of cycles of chemotherapy;

Proportion of patients with progression according to RECIST 1.1 criteria;

Median time from advanced EC diagnosis to progression (calculated between the date of histologically confirmed advanced EC diagnosis and the date of EC progression according to RECIST 1.1 criteria);

Age at the histologically confirmed diagnosis of aggressive advanced Endometrial cancer

Proportion of patients of different races and ethnicities

Proportion of patients with presence of a family oncology history (in first-degree relatives) overall and by each disease;

Proportion of patients with a personal oncology history overall and by each disease;

Proportion of patients with presence of EC development risk factors:

• Obesity (physician-diagnosed or based on BMI>30 kg/m2), current of in the past
• Smoking status
• Early menarche (before 12 years)
• Late menopause (after 55 years)
• Endometrial hyperplasia
• Nulliparity

Proportion of patients with each category by Eastern Cooperative Oncology Group assessment at the inclusion, grades from 0 (Fully active, able to carry on all pre-disease performance without restriction) to 5 (Dead)

Proportion of patients with concomitant diseases overall and by each disease;

Proportion of patients receiving concomitant therapies overall and by each medicine (by ATC);

Proportion of patients with each clinical stage by TNM (a standard method for classifying the extent of malignant tumors) classification. The size and extent of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N), and whether the cancer has metastasized to distant parts of the body (M).

Proportion of patients with each clinical stage by FIGO (The International Federation of Gynecology and Obstetrics (Fédération Internationale de Gynécologie et d'Obstétrique)) classification. FIGO stages are from I (Tumor confined to the corpus uteri) to IVB (Distant metastases, including intra-abdominal metastases and/or inguinal lymph nodes)

Proportion of patients with each histological type of tumour

Proportion of patients with each category by grade of tumor differentiation from G1 (high grade) - highly differentiated) to G3 (low grade) - poorly differentiated;

The rate of each diagnostic methods used in a routine practice in the diagnostics process of Endometrial cancer

Proportion of patients underwent surgery overall and by each type (if applicable);

Proportion of patients received any radiation therapy (RT) overall and by each type (if applicable);

Proportion of patients with each radiation area (if applicable) (to be calculated in patients who received any RT);

Total radiation therapy (RT) dose (Gray) by each radiation area (to be calculated in patients who received any RT).

Proportion of patients with several biomarkers present at the same time, for example, two, three, four, etc. including positive status for POLEm / dMMR/pMMR / p53abn / PD-L1 and positive HER2 expression.