BACKGROUND: Cholangiocarcinoma and gallbladder cancer are difficult to treat curatively. The treatment of choice is surgery, dependent on detection at a resectable stage. No chemotherapy or radiotherapy options have shown substantial activity. Gemcitabine has demonstrated response in similar cancers. Considering the lack of treatment options for cholangiocarcinoma and gallbladder cancer, a systematic review of the evidence on gemcitabine use for these indications was performed.
OBJECTIVE: To perform a systematic review to evaluate the role of gemcitabine in the treatment of cholangiocarcinoma and gallbladder cancer.
METHODS: The MEDLINE database was searched (1996 to March 2005) using the medical subject headings 'gemcitabine' and 'gallbladder neoplasms' with results limited to English only. Proceedings from the 1998 to 2004 meetings of the American Society of Clinical Oncology, including the 2004 Gastrointestinal Cancers Symposium, were searched for relevant abstracts. The Canadian Medical Association infobase and the National Guidelines Clearinghouse were also searched for practice guideline reports. Reports were selected and reviewed by two reviewers, and the reference lists from those were searched for additional trials.
RESULTS: A total of 13 single-arm phase II trial reports were obtained.
CONCLUSIONS: In appropriate patients with gallbladder cancer or cholangiocarcinoma, surgery offers the best chance for survival and should remain the first treatment of choice. For patients not considered candidates for surgery, but willing and able to tolerate chemotherapy alone or in combination with a fluoropyrimidine (such as 5-fluorouracil or capecitabine), gemcitabine appears to be a reasonable alternative to best supportive care, although this conclusion has not been confirmed with a randomized controlled trial.