New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 465
- 试验地点
- 1
- 主要终点
- Response to platinum-based chemotherapy
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •other pathological types;
- •without NACT or IDS;
- •incomplete pretreatment data;
- •lost to follow-up.
结局指标
主要结局
Response to platinum-based chemotherapy
时间窗: At least 6 months after initial 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.
次要结局
- 3-year progression-free survival (PFS)(3 years)
- 3-year overall survival (OS)(3 years)