상피성 난소암 환자에서 Platinum 중심 공고항암요법 (Consolidation Therapy)의 유효성 및 안전성에 관한 예비연구

Abstract

Objective : The aim of this study is to evaluate the efficacy of additional three cycles of platinum- based chemotherapy in epithelial ovarian cancer patients with clinical complete response (CR). Methods : Patients with histologically confirmed epithelial ovarian cancer stage II-IV and showing clinical CR after primary surgery and six cycles of chemotherapy with platinum-based chemotherapy entered into the study. Three cycles of platinum/paclitaxel (cisplatin/paclitaxel or carboplatin/paclitaxel) or cyclophosphamide/cisplatin, cyclophosphamide/adriamycin/cisplatin were administered as a consolidation chemotherapy only in patients with an agreement to informed consent. Results : A total of 96 patients entered into the study. According to informed consent, 47 patients were treated by consolidation chemotherapy and 49 patients were followed up without further treatment. The median follow-up period was 30.5 months in total patients. The mean number of chemotherapy courses administered on the consolidation arm was 2.7. The median actuarial disease-free survival for the patients without consolidation chemotherapy arm was 26.0 months and consolidation arm, 27.0 months. No difference was detected in disease-free survival (p=0.89). Median overall survival is not reached, but there was no significant difference between the two arms of the trial (p=0.76). WHO grade 3-4 toxicity criteria were emesis (4.1% vs. 2.1%), anemia and/or neutropenia (10.2% vs. 19.1%), and others (4.1% vs. 21.3%). Conclusion : Although sample size is small and not randomized, these results suggest that platinum- based consolidation chemotherapy do not provide a favorable outcome in terms of disease-free survival in patients with a clinical CR after debulking surgery and six cycles of same regimen.