Intervention debulking surgery in advanced epithelial ovarian cancer.

Objective: To study whether intervention debulking surgery improves survival in patients with advanced ovarian cancer who have bulky (> 2 cm) residual disease after primary surgery.

Design: A prospective multicentre randomised study.

Setting: Hospitals in the West Midlands.

Subjects: Ovarian cancer patients with bulky residual disease after primary surgery who are considered well enough to receive cis-platinum based chemotherapy and further surgery.

Methods: Eligible patients were randomised to receive combination chemotherapy alone or combined with intervention debulking surgery.

Main Outcome Measure: Survival was assessed using product limit method and log-rank test.

Results: Seventy-nine patients were entered into the study. Thirty-seven patients were randomised to intervention debulking surgery, 25 (67%) of whom underwent intervention debulking surgery, which was performed a median of 13 weeks after primary surgery. The median survival for the intervention debulking surgery group was 15 months (95% CI 10-20 mo) and that of those randomised to chemotherapy alone, which was 12 months (95% CI 8-16 mo), were not significantly different (hazard ratio = 0.71; 95% CI 0.44-1.13).

Conclusion: Intervention debulking surgery may not improve survival in patients with advanced ovarian cancer.