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A phase II trial of S-1 and cisplatin in patients with metastatic or relapsed biliary tract cancer.

AbstractBACKGROUND:
Optimal chemotherapy for advanced biliary tract cancer (BTC) is yet to be defined. We carried out this study to evaluate the efficacy and toxicity of combination chemotherapy with S-1 and cisplatin in metastatic or relapsed BTC.
PATIENTS AND METHODS:
Patients with pathologically proven BTC were eligible. The chemotherapy regimen consisted of S-1 (40 mg/m(2) p.o. b.i.d. from D1-14) and cisplatin (60 mg/m(2) on D1), repeated every 3 weeks.
RESULTS:
Fifty-one BTC patients (metastatic:relapsed = 37:14, Gall-bladder:intrahepatic bile ducts:extrahepatic bile ducts = 16:25:10) were enrolled from January 2005 to December 2006. Median age was 57 years (range, 31-71) and most patients had a good performance status. The overall response rate was 30% [95% confidence interval (CI), 17.3-42.7] and complete response was observed in two patients (4%), partial response in 13 (26%), stable disease in 21 (42%), and progressive disease in 9 (18%). With a median follow-up of 12.4 months, the median time to progression was 4.8 months (95% CI, 3.3-6.3) and median overall survival was 8.7 months (95% CI, 6.0-11.4). Major toxic effects were grade 3/4 neutropenia (8.9% of all cycles) and febrile neutropenia was observed in six cycles (2.7% of all cycles).
CONCLUSION:
Combination chemotherapy with S-1 and cisplatin was a moderately effective outpatient-based regimen in BTC patients. Toxic effects were moderate but manageable.
AuthorsY J Kim, S-A Im, H G Kim, S Y Oh, K W Lee, I S Choi, D Y Oh, S H Lee, J H Kim, D W Kim, T Y Kim, S W Kim, D S Heo, Y B Yoon, Y J Bang
JournalAnnals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 19 Issue 1 Pg. 99-103 (Jan 2008) ISSN: 1569-8041 [Electronic] England
PMID17846018 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • Pyridines
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid
  • Cisplatin
  • gimeracil
Topics
  • Adenocarcinoma (drug therapy, secondary)
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Biliary Tract Neoplasms (drug therapy, pathology)
  • Cisplatin (administration & dosage, adverse effects)
  • Disease Progression
  • Disease-Free Survival
  • Drug Combinations
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neutropenia (chemically induced)
  • Oxonic Acid (administration & dosage, adverse effects)
  • Pyridines (administration & dosage, adverse effects)
  • Salvage Therapy
  • Survival Analysis
  • Tegafur (administration & dosage, adverse effects)
  • Thrombocytopenia (chemically induced)

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