title: Guidelines for chemotherapy of biliary tract and ampullary carcinomas.
abstract: Few randomized controlled trials (RCTs) with large numbers of patients have been conducted to date in patients with biliary tract cancer, and standard chemotherapy has not been established yet. In this article we review previous studies and clinical trials regarding chemotherapy for unresectable biliary tract cancer, and we present guidelines for the appropriate use of chemotherapy in patients with biliary tract cancer. According to an RCT comparing chemotherapy and best supportive care for these patients, survival was significantly longer and quality of life was significantly better in the chemotherapy group than in the control group. Thus, chemotherapy for patients with biliary tract cancer seems to be a significant treatment of choice. However, chemotherapy for patients with biliary tract cancer should be indicated for those with unresectable, locally advanced disease or distant metastasis, or for those with recurrence after resection. That is why making the diagnosis of unresectable disease should be done with greatest care. As a rule, pathological diagnosis, including cytology or histopathological diagnosis, is preferable. Chemotherapy is recommended in patients with a good general condition, because in patients with general deterioration, such as those with a performance status of 2 or 3 or those with insufficient biliary decompression, the benefit of chemotherapy is limited. As chemotherapy for unresectable biliary tract cancer, the use of gemcitabine or tegafur/gimeracil/oteracil potassium is recommended. As postoperative adjuvant chemotherapy, no effective adjuvant therapy has been established at the present time. It is recommended that further clinical trials, especially large multi-institutional RCTs (phase III studies) using novel agents such as gemcitabine should be performed as soon as possible in order to establish a standard treatment.
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Furuse
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Takada
authors.forename: Masaru
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Shuichi
authors.initials: S
authors.lastname: Miyakawa
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Tsukada
authors.forename: Masato
authors.initials: M
authors.lastname: Nagino
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kondo
authors.forename: Hiroya
authors.initials: H
authors.lastname: Saito
authors.forename: Toshio
authors.initials: T
authors.lastname: Tsuyuguchi
authors.forename: Koichi
authors.initials: K
authors.lastname: Hirata
authors.forename: Fumio
authors.initials: F
authors.lastname: Kimura
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Yoshitomi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nozawa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yoshida
authors.forename: Keita
authors.initials: K
authors.lastname: Wada
authors.forename: Hodaka
authors.initials: H
authors.lastname: Amano
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Miura
mesh_terms: D014670:Ampulla of Vater; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D002277:Carcinoma / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D019317:Evidence-Based Medicine / Q000379:methods; D006801:Humans; D016032:Randomized Controlled Trials as Topic
chemical_list: D000970:Antineoplastic Agents