1. Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine:A Randomized Phase II Trial
- Author
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Finn Ole Larsen, Alice Markussen, Laura Vittrup Diness, and Lars Henrik Jensen
- Subjects
0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,randomized phase II trial ,medicine.medical_treatment ,Oxaliplatin 50 MG ,cisplatin ,chemotherapy ,Gastroenterology ,lcsh:RC254-282 ,Article ,Capecitabine ,Cholangiocarcinoma ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,biliary tract cancer ,medicine ,Overall survival ,Chemotherapy ,Cisplatin ,Biliary tract cancer ,business.industry ,oxaliplatin ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Randomized phase II trial ,Gemcitabine ,Oxaliplatin ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,business ,cholangiocarcinoma ,medicine.drug - Abstract
This study is an investigator-initiated randomized phase II trial focusing on the treatment of advanced biliary tract cancer with either oxaliplatin 50 mg/m2 and gemcitabine 1000 mg/m2 on day 1 in a two-week cycle with capecitabine 650 mg/m2 twice-daily continuously or cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on day 1 and day 8 in a three-week cycle. One-hundred patients were included. Forty-seven patients received oxaliplatin, gemcitabine, and capecitabine with a median progression-free survival (mPFS) of 5.7 months (95% CI 3.0&ndash, 7.8) and a median overall survival (mOS) of 8.7 months (95% CI 6.5&ndash, 11.2). Forty-nine patients received cisplatin and gemcitabine with a mPFS of 7.3 months (95% CI 6.0&ndash, 8.7) and a mOS of 12.0 months (95% CI 8.3&ndash, 16.7). This trial confirms a mOS of 12 months with cisplatin and gemcitabine, as found in earlier trials. With a superior tumor control rate of 79% vs. 60% (p = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721, p = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731, p = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.
- Published
- 2020
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