title: Capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective single-center study.
abstract: BACKGROUND
  Palliative chemotherapy is currently the primary therapeutic approach in the treatment of advanced biliary tract cancer (BTC). Our aim was to assess the efficacy and safety of capecitabine plus cisplatin as first-line chemotherapy for patients with advanced BTC and to analyze the relationship between the level of CA19-9 and clinical outcome.
  
  
  METHODS
  We retrospectively reviewed the records of patients who had unresectable, metastatic or recurrent BTC who were treated with capecitabine plus cisplatin. Capecitabine was administered orally at a dose of 1,000 mg/m(2) twice a day for 14 days, followed by a 1-week rest period. Cisplatin was administered intravenously on days 1 and 8 at a dose of 30 mg/m(2) for 60 min every 3 weeks.
  
  
  RESULTS
  A total of 176 patients were enrolled. Among the 143 assessable patients, 24 (17%) had a partial response. A complete response was radiologically confirmed in 1 patient who had gallbladder cancer. Sixty-two patients (43%) had stable disease and 56 patients (39%) had progressive disease. With a median follow-up of 5.7 months, the median time-to-progression (TTP) was 3.7 months (95% CI 3.1-4.3) and the median overall survival (OS) was 7.4 months (95% CI 6.1-8.7). There was a significant positive correlation between CA19-9 response and TTP (r = 0.66, p = 0.01). CA19-9 response was also significantly correlated with OS (r = 0.57, p < 0.01). The most common grade 3/4 toxicities were nausea/vomiting [12 patients (6.8%)].
  
  
  CONCLUSIONS
  Our results indicate that the capecitabine/cisplatin regimen is well tolerated and has moderate activity against advanced BTC. The CA19-9 response may be a suitable surrogate marker for patients with BTC who are treated with capecitabine/cisplatin.
authors: Center for Liver Cancer, National Cancer Center, Goyang, Republic of Korea.
authors: Sang Myung
authors: SM
authors: Woo
authors: Woo Jin
authors: WJ
authors: Lee
authors: Sung-Sik
authors: SS
authors: Han
authors: Sang-Jae
authors: SJ
authors: Park
authors: Tae Hyun
authors: TH
authors: Kim
authors: Young Hwan
authors: YH
authors: Koh
authors: Hyun Bum
authors: HB
authors: Kim
authors: Eun Kyung
authors: EK
authors: Hong
authors: Joong-Won
authors: JW
authors: Park
authors: Chang-Min
authors: CM
authors: Kim
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy / Q000378:metabolism / Q000401:mortality; D017734:Bile Ducts, Extrahepatic; D001653:Bile Ducts, Intrahepatic; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D018395:CA-19-9 Antigen / Q000378:metabolism; D000069287:Capecitabine; D018281:Cholangiocarcinoma / Q000188:drug therapy / Q000378:metabolism / Q000401:mortality; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005706:Gallbladder Neoplasms / Q000188:drug therapy / Q000378:metabolism / Q000401:mortality; D006801:Humans; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D018395:CA-19-9 Antigen; D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil