New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer

Study Overview
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Brief Summary
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A validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (HGSOC) patients undergoing neoadjuvant chemotherapy (NACT) is still lacking. To address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (ONCPI) to improve predictive accuracy. We analyzed the clinicopathological characteristics of advanced HGSOC patients receiving platinum-based NACT. Blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. Omental hematoxylin and eosin (H&E) stained slides were selected for the assessment of chemotherapy response score (CRS). Logistic regression analysis and Cox proportional hazards regression model were utilized to develop a prognostic index.

Detailed Description
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The clinicopathological data of patients newly diagnosed with high-grade serous ovarian cancer in Sun Yat-sen Memorial Hospital were collected and screened. Statistical analysis of hematological indicators that may be related to inflammation before platinum-based therapy in patients who met the inclusion criteria, including but not limited to: Absolute white blood cell count, absolute neutrophil count, absolute lymphocyte count, absolute monocyte count, platelet count, hemoglobin and fibrinogen were calculated. NLR, MLR, PLR, FLR and SII were calculated, and the correlation between the above indicators and tumor grade, stage, platinum-based drug sensitivity and prognosis was analyzed. CRS scoring was performed using H&E sections of omentum obtained during IDS surgery. logistic regression and Cox regression were used to analyze the independent risk factors affecting the sensitivity of neoadjuvant platinum-based chemotherapy and the prognosis of patients. K-M analysis and ROC curve were used to analyze the predictive value of NLR combined with CRS ONCPI index for the response of high-grade serous ovarian cancer to platinum therapy.

Official Title
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New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer

Conditions
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Ovarian Cancer, Neoadjuvant Chemotherapy, Prognostic Cancer Model

Intervention / Treatment
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* Diagnostic Test: CRS scoring
* Diagnostic Test: Routine blood laboratory testing before treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of HGSOC by two experienced pathologists; clinical stage III-IV according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) guideline; Eastern Cooperative Oncology Group (ECGO) performance status of 0 to 1; no prior anti-cancer therapy; received ≥ 3 cycles of platinum-based NACT followed by IDS; complete pretreatment blood test results and clinical and imaging data. Exclusion Criteria: other pathological types; without NACT or IDS; incomplete pretreatment data; lost to follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NACT Group<br> | Diagnostic Test: CRS scoring<br>* For pathological evaluation, the omental specimens resected during the IDS were stained with haematoxylin and eosin (H&E) and reviewed independently by two gynecologic pathologists, both blinded to the clinical data and each other's results. The pathology slide obtained from omentum, usually the site with the most viable tumor, was selected for CRS assessment according to the three-tiered CRS system recommended by 2019 ESMO ovarian cancer guidelines<br>Diagnostic Test: Routine blood laboratory testing before treatment<br>* The routine blood tests and tumor marker measurements, including CA125, HE4, and inflammation-related serum biomarkers including neutrophils, lymphocytes, monocytes, fibrinogen, and platelets, were conducted within three days before the first NACT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to platinum-based chemotherapy | After NACT-IDS and postoperative adjuvant chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant. | At least 6 months after initial chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression-free survival (PFS) | PFS was calculated from the date of the first NACT until disease progression or death due to any cause. | 3 years | 
| 3-year overall survival (OS) | OS was calculated from the date of the first NACT administration until death due to any cause. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-grade serous ovarian cancer, Neoadjuvant chemotherapy, Prognostic index