Furuse Junji, Takada Tadahiro, Miyazaki Masaru, Miyakawa Shuichi, Tsukada Kazuhiro, Nagino Masato, Kondo Satoshi, Saito Hiroya, Tsuyuguchi Toshio, Hirata Koichi, Kimura Fumio, Yoshitomi Hideyuki, Nozawa Satoshi, Yoshida Masahiro, Wada Keita, Amano Hodaka, Miura Fumihiko
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan.
J Hepatobiliary Pancreat Surg. 2008;15(1):55-62. doi: 10.1007/s00534-007-1280-z. Epub 2008 Feb 16.
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.
迄今为止，针对胆道癌患者开展的纳入大量患者的随机对照试验（RCT）较少，标准化疗方案尚未确立。在本文中，我们回顾了以往关于不可切除胆道癌化疗的研究和临床试验，并给出了胆道癌患者合理使用化疗的指南。根据一项比较化疗与最佳支持治疗的RCT，化疗组患者的生存期显著更长，生活质量显著优于对照组。因此，化疗似乎是胆道癌患者的重要治疗选择。然而，胆道癌患者的化疗应适用于不可切除、局部晚期疾病或远处转移的患者，或切除术后复发的患者。这就是为什么在诊断不可切除疾病时应格外谨慎。通常，病理诊断，包括细胞学或组织病理学诊断，更为可取。一般状况良好的患者推荐进行化疗，因为对于一般状况较差的患者，如体能状态为2或3级的患者或胆道减压不足的患者，化疗的益处有限。对于不可切除的胆道癌化疗，推荐使用吉西他滨或替吉奥。作为术后辅助化疗，目前尚未确立有效的辅助治疗方案。建议尽快开展进一步的临床试验，尤其是使用吉西他滨等新型药物的大型多机构RCT（III期研究），以确立标准治疗方案。
