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.
RCT Entities:
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 cancerpatients 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.
Authors: U Wagner; P Harter; F Hilpert; S Mahner; A Reuß; A du Bois; E Petru; W Meier; P Ortner; K König; K Lindel; D Grab; P Piso; O Ortmann; I Runnebaum; J Pfisterer; D Lüftner; N Frickhofen; F Grünwald; B O Maier; J Diebold; S Hauptmann; F Kommoss; G Emons; B Radeleff; M Gebhardt; N Arnold; G Calaminus; I Weisse; J Weis; J Sehouli; D Fink; A Burges; A Hasenburg; C Eggert Journal: Geburtshilfe Frauenheilkd Date: 2013-09 Impact factor: 2.915