A pilot study of three-cycle consolidation chemotherapy with paclitaxel and platinum in epithelial ovarian cancer patients with clinical complete response after paclitaxel and platinum chemotherapy.

The aim of this study is to evaluate the efficacy of three additional cycles of paclitaxel and platinum chemotherapy in epithelial ovarian cancer patients with clinical complete response (CR). Patients with histologically confirmed epithelial ovarian cancer stages II-IV with clinical CR after primary surgery and six cycles of chemotherapy with paclitaxel/platinum entered into the study. Three cycles of paclitaxel/platinum (cisplatin, carboplatin) were administered as a consolidation chemotherapy only in patients who agreed to the informed consent. Patients without further treatment served as controls. A total of 81 patients entered into the study. According to the informed consent, 42 patients were treated by the consolidation chemotherapy, and 39 patients were followed up without further treatment. The median actuarial disease-free survival for the patients with and without consolidation chemotherapy was 25.0 months and 26.0 months, respectively (P= 0.80). The median overall survival is not reached. World Health Organization grade 3-4 toxicities in the consolidation arm were increased but showed no significant differences statistically. Although the sample size is small and not randomized, these results suggest that three cycles of consolidation chemotherapy with paclitaxel/platinum might not provide a favorable outcome in patients with a clinical CR.