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Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting.

japanese journal of clinical oncology

Safety and Effectiveness of Gemcitabine in 260 Patients with Biliary Tract Cancer in a Japanese Clinical Practice Based on Post-marketing Surveillance in Japan