The aim of this single center, open label, single arm phase II trial was to assess the efficacy and toxicity of gemcitabine, S-1 and leucovorin (LV) combination therapy for advanced pancreatic cancer (UMIN-CTR 000010678).
Chemotherapy-naïve patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m2 by 30min infusion on days 1, S-1 40mg/m2 orally twice daily and LV 25mg orally twice daily on days 1 to 7 every 2 weeks. Primary end point was progression free survival (PFS), and secondary endpoints were overall survival (OS), response rate, disease control rate and adverse events.
A total of 49 patients with advanced pancreatic cancer (19 locally advanced and 30 metastatic) were enrolled between May 2013 and March 2017. Median age was 68 (range, 44-84) and PS was 0 in 26 and 1 in 23. Overall response rate and disease control rate were 32.7% and 87.8%. The median PFS and OS were 10.8 (95% confidence interval [CI], 7.4-13.5) and 20.7 (95% CI 13.0-NA) months with 1-year survival rate of 73.4%. The median PFS of locally advanced and metastatic diseases was 12.7 and 7.4 months, and the median OS of locally advanced and metastatic diseases was 26.1 and 18.8 months, respectively. Conversion surgery was performed in 2 patients among 19 locally advanced diseases. The reasons for treatment failure was disease progression in 31, unacceptable toxicities in 4, deteriorated general conditions in 6, consent withdrawn in 3, others in 3. A second line chemotherapy was introduced in 29 patients. Major Grade 3-4 toxicities were neutropenia (22.4%) and mucositis (14.3%). No toxicity related death was observed.
In this phase II trial, gemcitabine, S-1 and LV combination therapy was tolerable and can potentially be a treatment option for advanced pancreatic cancer.
Clinical trial identification
Legal entity responsible for the study
The University of Tokyo.
Has not received any funding.
All authors have declared no conflicts of interest.