Clinical trial NCT06120309: New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
Official title: New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ovarian Cancer
Neoadjuvant Chemotherapy
Prognostic Cancer Model
Keywords: High-grade serous ovarian cancer
Neoadjuvant chemotherapy
Prognostic index
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 465
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced HGSOC receiving platinum-based neoadjuvant chemotherapy (NACT) before interval debulking surgery (IDS) and postoperative adjuvant chemotherapy were enrolled

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response to platinum-based chemotherapy
timeFrame: At least 6 months after initial chemotherapy
Secondary outcomes:
measure: 3-year progression-free survival (PFS)
timeFrame: 3 years
measure: 3-year overall survival (OS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
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.
citation: 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-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062.
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 disease. J Cancer. 2021 Jan 1;12(3):946-953. doi: 10.7150/jca.52711. eCollection 2021.
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 lung cancer patients receiving neoadjuvant chemoimmunotherapy and its association with the immune-related tumor microenvironment: a multi-center study. Cancer Immunol Immunother. 2023 Mar;72(3):783-794. doi: 10.1007/s00262-022-03262-w. Epub 2022 Sep 3.
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/jcm12062155.