The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University310 enrolled

Overview

Ovarian cancer is associated with the highest mortality of all gynecologic cancers. In patients with newly diagnosed advanced ovarian cancer after platinum-containing chemotherapy plus bevacizumab therapy, maintenance therapy with olaparib plus bevacizumab significantly prolongs progression-free survival (PFS) in the intended population and is recommended by guidelines. However, study shows those homologous recombinant repair defect (HRD) but Breast Cancer Susceptibility Gene(BRCA) wild type have limited benefit from maintenance therapy with olaparib plus bevacizumab when surgery is with residual(no-R0). Can hyperthermic intraperitoneal chemotherapy(HIPEC) improve the benefits of first-line maintenance therapy in patients with non-R0 resection, HRD? The cohort study will enroll 310 patients with HRD and no-R0 resection who conduct HIPEC during primary treatment and then have olaparib plus bevacizumab as maintenance. Follow-up period is 30 months. The primary endpoint is PFS.

Study Type

OBSERVATIONAL

Enrollment

310

Conditions

Ovarian Cancer

Interventions

HIPECPROCEDURE

HIPEC is given after primary or interval debulking surgery.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-70 years * Eastern Cooperative Oncology Group (ECOG) score 0-1 * Adequate kidney function (blood creatinine 58-96µmol/L) * Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L) * Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5 * surgery with residual * eligible to the maintenance therapy of olaparib plus bevacizumab Exclusion Criteria: * Expected life span ≤8 weeks * Complicated with any other known malignancies * Patients with dysfunction of swallow and digestion * Patients who had received any kind of poly adenosinediphosphate-ribose polymerase（PARP）inhibitor * refractory hypertension

Outcomes

Primary Outcomes

PFS

Time frame: from the date of recruitment to the time of recurrence, assessed up to 30 months

Secondary Outcomes

overall survival

Time frame: from the date of recruitment to the time of death from any cause, assessed up to 30 months

adverse effect

Time frame: from the date of recruitment up to 30 months