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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06120309
• Other study ID #: SYSKY-2023-963-01
• Status: Enrolling by invitation
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

1. The clinicopathological data of patients newly diagnosed with high-grade serous ovarian cancer in Sun Yat-sen Memorial Hospital were collected and screened.

2. 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.

3. CRS scoring was performed using H&E sections of omentum obtained during IDS surgery.

4. 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.

5. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 465
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. confirmed diagnosis of HGSOC by two experienced pathologists;

2. clinical stage III-IV according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) guideline;

3. Eastern Cooperative Oncology Group (ECGO) performance status of 0 to 1;

4. no prior anti-cancer therapy;

5. received = 3 cycles of platinum-based NACT followed by IDS;

6. complete pretreatment blood test results and clinical and imaging data.

Exclusion Criteria:

1. other pathological types;

2. without NACT or IDS;

3. incomplete pretreatment data;

4. lost to follow-up.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Neoadjuvant Chemotherapy
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• CRS scoring
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
• Routine blood laboratory testing before treatment
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.

Locations

Country	Name	City	State
China	The Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

Colombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ES — View Citation

Hudry D, Becourt S, Scambia G, Fagotti A. Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision-a Literature Review. Curr Oncol Rep. 2022 Dec;24(12):1661-1668. doi: 10.1007/s11912-022-01318-9. Epub 2022 Aug 15. — View Citation

Li C, Wu J, Jiang L, Zhang L, Huang J, Tian Y, Zhao Y, Liu X, Xia L, E H, Gao P, Hou L, Yang M, Ma M, Su C, Zhang H, Chen H, She Y, Xie D, Luo Q, Chen C. The predictive value of inflammatory biomarkers for major pathological response in non-small cell lun — View Citation

Liang WF, Wang LJ, Li H, Liu CH, Wu MF, Li J. The added value of CA125 normalization before interval debulking surgery to the chemotherapy response score for the prognostication of ovarian cancer patients receiving neoadjuvant chemotherapy for advanced di — View Citation

Rodolakis I, Pergialiotis V, Liontos M, Haidopoulos D, Loutradis D, Rodolakis A, Bamias A, Thomakos N. Chemotherapy Response Score in Ovarian Cancer Patients: An Overview of Its Clinical Utility. J Clin Med. 2023 Mar 10;12(6):2155. doi: 10.3390/jcm1206215 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	3-year overall survival (OS)	OS was calculated from the date of the first NACT administration until death due to any cause.	3 years