HIPEC in Ovarian Cancer: The First Case Control Study in Mexican Patients With 10-year Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Instituto de Seguridad Social del Estado de Mexico y Municipios
- Enrollment
- 144
- Primary Endpoint
- free overall survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Objectives:
Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study
Methods:
Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.
Detailed Description
Epithelial ovarian cancer has the highest mortality of all gynecologic tumors in the world wide. Patients are diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage III to IV disease in 75%. The 10-year survival of women with advanced-stage ovarian cancer is 10% to 15% and has not improve in the past 20 years. Despite treatment with maximal cytoreductive surgery (CRS) and platinum-based chemotherapy, approximately 70% of patients with advanced-stage disease relapse within 18 months. Given this high number of recurrences, new approaches are needed to improve outcomes for these patients. Historically, peritoneal carcinomatosis represents a devastating form of cancer progression with a very poor prognosis. Objectives: Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study Methods: Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.
Investigators
Juan Manuel Medina Castro
Peritoneal Malignacy neoplasm coordinator
Instituto de Seguridad Social del Estado de Mexico y Municipios
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Epithelial ovarian cancer confirmed
- •FIGO stage III-IV or carcinomatosis recurrence
- •No comorbidities or controlled comorbidities
Exclusion Criteria
- •without carcinomatosis
Outcomes
Primary Outcomes
free overall survival
Time Frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve
free recurrence survival
Time Frame: 10 years
survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve
Secondary Outcomes
- factors associated with survival(10 years)