Gemcitabine and S-1 combination chemotherapy may be an alternative therapeutic strategy in patients with metastatic biliary tract cancer, a study published in the journal Cancer Chemotherapy and Pharmacology has shown.

For the phase II study, researchers sought to evaluate the safety and efficacy of gemcitabine and S-1, an oral chemotherapy agent related to fluorouracil, combination therapy in patients with metastatic biliary tract cancer.

Researchers enrolled 83 patients between 2005 and 2010. All patients received gemcitabine 1,000mg/m2 IV over 30 minutes on days 1 and 8 plus S-1 80mg/m2 orally on days 1-14 of each 21-day cycle.

Continue Reading

Results showed that the overall response rate was 20.6% (95% CI: 8.5-36.7) in the per-protocol population and 18.4% (95% CI: 6.1-30.7) in the intention-to-treat population. The median duration of response was 10.8 months.

RELATED: Second-Line mFOLFOX3 Has Modest Effect in Previously Treated Biliary Tract Cancer

Researchers found that the median progression-free survival was 4.4 months (95% CI: 60.6-87.6) and the median overall survival was 9.0 months (95% CI: 4.0-13.9) in the intention-to-treat population. The 1-year survival rate was 44.7% (95% CI: 29.0-61.5).

In regard to safety, the most common grade 3/4 non-hematologic toxicities were hepatotoxicity, anorexia, and renal toxicity. Neutropenia and anemia occurred in 37.1% and 25.7% of patients, respectively.


  1. Kim HS, Kim HY, Zang DY, et al. Phase II study of gemcitabine and S-1 combination chemotherapy in patients with metastatic biliary tract cancer. Cancer Chemother Pharmacol. 2015;75(4):711-718.