A pilot study of combination intraperitoneal recombinant human endostatin and chemotherapy for refractory malignant ascites secondary to ovarian cancer.

The management of refractory malignant ascites (MA) due to ovarian cancer (OC) remains a difficult clinical problem. A total of 23 eligible patients with refractory MA due to OC were treated with combined intraperitoneal therapy repeated 4 weeks, which consisted of paclitaxel 100 mg m(-2) (over 3 h) on day 1, 5-FU 600 mg m(-2) on day 1-3 followed by recombinant human endostatin 60 mg on day 4. The objective response rate was 60.9 % (14/23). The median time to progression and overall survival was 5.8 and 12.9 months, respectively. Treatment-related toxicities were uncommon and manageable without therapy-associated deaths. The mean Karnofsky performance status score was significantly improved from 60.0 ± 1.89 at enrollment to 70.0 ± 2.59 at 2 weeks after the first cycle of therapy (P = 0.000). Moreover, the mean score of overall ascites-associated symptoms was also increased significantly from 5.1 ± 0.32 to 4.0 ± 0.20 (P = 0.002). There were remarkable improvements in 7 out of 9 individual ascites-associated symptoms including well being, anxiety, abdominal distention, vomiting, anorexia, fatigue, and dyspnea as well (all P < 0.05). These results suggest that combination intraperitoneal recombinant human endostatin and chemotherapy is effective and safe in patients with refractory MA secondary to OC and significantly improves patients' quality of life with encouraging survival, which might highlight more effective treatment for this challenging disease and merits further investigation.