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

NCT06120309UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

465

Start Date

2023-11-01

Completion Date

2023-12-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

CRS scoringRoutine blood laboratory testing before treatment

Conditions

Ovarian CancerNeoadjuvant ChemotherapyPrognostic Cancer Model

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: At least 6 months after initial chemotherapy

Secondary Outcomes

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.

Time frame: 3 years

3-year overall survival (OS)

OS was calculated from the date of the first NACT administration until death due to any cause.

Time frame: 3 years

Locations

The Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China

Linked Papers

2022-08-15

Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision—a Literature Review

Summarize the writings published in the last 5 years on the management of surgery in the first line of treatment for advanced ovarian cancer. For patients with a significant tumor burden, the neoadjuvant chemotherapy therapy (NACT) with interval debulking surgery (IDS) strategy shows comparable efficacy than primary debulking surgery (PDS) in terms of survival in randomized studies with less morbidity. Advanced epithelial ovarian cancer generates more than half cases a recurrence. First-line treatment is based on a chemotherapy regimen combining a platinum-based and a taxane-based, associated with surgery. This review considers papers of last 5 years of timing, thinking tools, and innovation in the management. The choice of strategy, PDS or IDS, would be a personalized recommendation. The challenge is to adapt the timing of the surgery to the patient's characteristics and that of her disease.

Linked Investigators

Delphine Hudry