Intravenous and Intraperitoneal Paclitaxel with S-1 for Refractory Pancreatic Cancer with Malignant Ascites: an Interim Analysis

Objectives Here, we reported an interim analysis of feasibility and safety in the first 10 cases of 30 cases in a phase II trial of intravenous and intraperitoneal paclitaxel combined with S-1 for gemcitabine-refractory pancreatic cancer with malignant ascites. Methods Paclitaxel was administered intravenously at 50 mg/m 2 and intraperitoneally at 20 mg/m 2 on days 1 and 8 every 3 weeks, and S-1 was administered at 80 mg/m 2 /day for 14 consecutive days, followed by 7-day rest. Results Between April 2011 and February 2012, ten patients were enrolled. A partial response was achieved in two patients (20 %) and a disease control rate of 50 %. The median time to progression and overall survival were 2.1 and 3.4 months, respectively. Malignant ascites was completely resolved in two patients (20 %). Major grade 3/4 adverse events were myelosuppression including neutropenia (50 %) and catheter-related infection (10 %). Conclusions This novel combination chemotherapy was feasible and showed promising results in pancreatic cancer patients with malignant ascites (clinical trial registration number: UMIN000005306).