Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

PRIMARY OBJECTIVES:

I. To determine the frequency of topoisomerase 2-alpha (TOPO2A) gene copy number alterations
(including deletions, gains, and amplification), immunohistochemical expression, and
chromosome 17 polysomy in tumor tissue samples from patients with advanced or recurrent
endometrial carcinoma treated with anthracycline-based therapy on Gynecologic Oncology Group
(GOG)-0177.

II. To assess the relationship between TOPO2A gene copy number alterations, TOPO2A protein
expression, chromosome 17 polysomy, and human epidermal growth factor receptor 2 (HER2)
status in tumor tissue samples from these patients.

III. To assess the association between TOPO2A status (TOPO2A gene copy number alterations
and TOPO2A protein expression), or chromosome 17 polysomy and clinical covariates (e.g.,
age, race/ethnicity, cell type, histologic grade, disease stage, regimen type).

IV. To assess the association between TOPO2A status or chromosome 17 polysomy with measures
of clinical outcome including response, progression-free survival, and overall survival of
patients treated with this regimen.

V. To evaluate the potential identification of cut points for TOPO2A protein expression with
potential prognostic value in patients treated with this regimen.

OUTLINE:

Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and
expression and chromosome 17 polysomy by fluorescent in situ hybridization (FISH) and
immunohistochemistry (IHC). Clinical information associated with each endometrial carcinoma
sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage, and regimen
type) is also collected.

Inclusion Criteria:

- Chemotherapy-naïve women with histologically documented measurable Stage III, Stage
IV or recurrent endometrial carcinoma with known HER2 status who participated in
Gynecologic Oncology Group (GOG)-0177 are eligible

- Patients must have given permission for their archival formalin-fixed,
paraffin-embedded primary, metastatic or recurrent tumor to be submitted and used for
GOG-0177, and at least one to three unstained slides must be available for FISH
analysis of TOPO2A and CEP17 and immunohistochemical staining for TOPO2A

Exclusion Criteria:

- Women who were not eligible or evaluable on GOG-0177

- Patients who do not have at least one unstained slide archival formalin-fixed,
paraffin-embedded primary, metastatic or recurrent tumor available for fluorescence
in situ hybridization (FISH) analysis of TOPO2A and CEP17 or immunohistochemical
expression of TOPO2A