According to a new study published in the journal Cancer Chemotherapy and Pharmacology, researchers have found that second-line mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) has modest effect and tolerable toxicity in patients with unresectable and/or metastatic biliary tract cancer who have been previously treated with gemcitabine-based chemotherapy.

For the phase 2 study, researchers enrolled 30 patients between March 2010 and June 2012 to receive oxaliplatin 85mg/m2 on day 1 and leucovorin 30mg on days 1 and 2 followed by 5-fluorouracil 1,500mg/m2 on days 1 and 2 every 2 weeks.

Results showed that of the 28 evaluable patients, one achieved a complete response and one achieved a partial response, equating to an overall response rate of 7.1% (95% CI: 0.9 – 23.5%). The median overall survival and progression free survival was 4.4 and 1.6 months, respectively.

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The most common non-hematologic adverse event was neuropathy, while the most common severe toxicity was hyperbilirubinemia. The most common severe hematologic toxicities were neutropenia and thrombocytopenia. One patient died as a result of neutropenic infection.

According to the American Cancer Society, bililary tract cancer is not common, and only about 2,000 to 3,000 people in the United States develop biliary tract cancer each year.


  1. Hwang IG, Jang J-S, Oh SY, et al. Phase II study of mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) as second-line treatment after gemcitabine failure in patients with unresectable/metastatic biliary tract cancer. Cancer Chemoth Pharm. 2015. [Epub ahead of print]. doi: 10.1007/s00280-015-2691-1.