ABSTRACT
Background: The aim of this study was to assess the role of consolidative intraperitoneal chemotherapy with carboplatin in decreasing relapse and increasing survival in advanced epithelial ovarian cancers, as well as evaluation of its toxicity
Methods: In this clinical trial 30 patients with epithelial ovarian cancer in stages II-IV who had complete surgery [optimal debulking surgery] received six standard cycles of intravenous carboplatin and paclitaxel. They were enrolled through non-random sequential selection
The control patients were similar to case group in stage [II-IV] and pathology [epithelial ovarian cancer]
The control group was evaluated retrospectively through hospital files. This clinical trial performed in Gynecology Oncology department in Tehran Valiasr University Hospital, during 2005-2010. They including 18 cases as the intervention group receiving intraperitoneal chemotherapy and 12 patients as the control group with only retrospective follow-up. The cases received 3 cycles of 400 mg/m[2] intraperitoneal carboplatin every 21 days following intravenous chemotherapy. Relapse of disease was diagnosed as increasing or even doubling CA125 serum titer during one month, or any CA125 above 100 IU, or an abdominal or pelvic mass in ultrasound or physical exam. Mean survival of two and five years, progression-free interval [PFI], overall survival [OS], relapse, demographic parameters, drug toxicities, pathologic types of cancers in two groups were coded and compared using SPSS 14. Any PO.05 was considered as a significant difference
Results: The mean ages of cases and controls were 52.4+/-8.6 and 55.1+/-11.5 years. The mean duration of relapse-free survival was 13+/-8.6 months for the cases and 9.5+/-4.3 months for the control patients [not statistically different, P>0.05]
The mean overall survival for cases and controls were 39+/-16.5 and 30.8+/-16.2 months, respectively [no significant difference, P>0.05]
The frequency of drug toxicities in the cases was 5.6%, and consisted of mild-to-moderate abdominal pain, nausea and vomiting
Conclusion: It seems that consolidation therapy with intraperitoneal carboplatin may not increase overall survival, reduce relapse rate or decrease mortality, though it does not induce considerable side effects. Since the mean survival in the intervention group was nine months more than controls, this difference may be clinically significant