Abstract 1742
Background
In Japan, gemcitabine based chemotherapy has been a standard regimen as one of the first-line treatment for unresectable pancreatic cancer. FOLFIRINOX was introduced in the second-line treatment for the gemcitabine-refractory pancreatic cancer of patients with an ECOG performance status score of 0 or 1. However, FOLFIRINOX requires close monitoring and must be limited to patients with good performance status because of significant toxicity. Further FOLFIRINOX requires a central veins port, and a trouble such as the port infection may occur. Therefore, it is difficult to administer FOLFIRINOX as second-line treatment. The first time in the world, we introduced IRISOX which substituted S-1 for fluorouracil and leucovorin in the second-line treatment. We aimed to evaluate the tolerance, safety, and clinical efficacy of IRISOX in the second-line treatment for the gemcitabine-refractory pancreatic cancer in a phase 1 study.
Methods
The primary objective was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IRISOX. The study was designed in accordance with a standard 3 + 3 method. Patients received 2-week cycles of treatment. Irinotecan was administered as an intravenous infusion at 100, 120, or 150 mg/m2 on day 1, S-1 was administered orally at 80 mg/m2 twice daily for 7 days, and oxaliplatin was administered as an intravenous infusion at 85 mg/m2 on day 1.
Results
Among the 12 patients enrolled, dose-limiting toxicity was observed in a patient at level 1 (irinotecan 100 mg/ m2 on day 1, S-1 80 mg/m2 twice daily, and oxaliplatin 85 mg/m2 on day 1) , and in two patients at level 2 (irinotecan 120 mg/ m2 on day 1, S-1 80 mg/m2 twice daily, and oxaliplatin 85 mg/m2 on day 1). The MTD was established as level 2. The RD was established as level 1. The most common grade 3-4 toxicity was neutropenia (33.3 %). The overall response rate was 9.0 %. The overall disease control rate was 45.4 %.
Conclusions
Based on the present results, the RD was determined as level 1 (irinotecan 100 mg/ m2 on day 1, S-1 80 mg/m2 twice daily, and oxaliplatin 85 mg/m2 on day 1). IRISOX was well tolerated and showed antitumor efficacy in the second-line treatment for the gemcitabine-refractory pancreatic cancer in a phase 1 study.
Clinical trial identification
UMIN000022964.
Legal entity responsible for the study
Kitasato University School of Medicine, Japan.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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