706PIrinotecan combined with oxaliplatin and S1 in patients with metastatic pancreatic adenocarcinoma

Abstract Background Prognosis of metastatic pancreatic adenocarcinoma is gloomy. To elicit a chemotherapy regimen with higher efficiency and with lower toxicities is critical important. Methods This was a one arm, phase 2, three-center study. Enrolled patients were histological or pathologically confirmed; treatment naive metastatic pancreatic adenocarcinoma. Enrolled patients were 18 years or older, with at least one measurable lesion and performance status between 0-2 with ECOG score. Irrinotecan 165 mg/m2 and oxaliplatin 85 mg/m2 were administered intravenous infusion on days 1, and S1 40 mg/m2 was administered orally on day 1-14, every 21 day a cycle until progressive disease or intolerable toxicities or patient death. The primary endpoint was overall survival and the second endpoints were progression-free survival and toxicities. Results A total of 41 patients were enrolled, median age was 59 year-old. There were 18 men and 23 women. The median progression-free survival was 4.33 (95% CI: 2.83-5.88) and median overall survival was 11.00 (95% CI: 9.16-12.84). There were 38 patients validated for efficiency evaluation. There was no complete response, the partial response rate, stable disease and progression disease was 42.11% (16/38), 31.58% (12/38) and 26.32% (10/38) respectively. The most common adverse effect was mild to moderate nausea, vomiting, neutropenia and thrombocytopenia. The 3/4 degree neutropenia and thrombocytopenia were 29.27% (12/41) and 12.20% (5/41) respectively. Conclusions Irinotecan combined with oxaliplatin and S1 was effective in metastatic pancreatic adenocarcinoma; its toxicities were mild to moderate and tolerable. Furthermore, patients to enrol the study is needed. Clinical trial identification NCT03726021. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.