A phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for unresectable biliary tract cancer
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- Hayashi, T., Ishiwatari, H., Yoshida, M. et al. Int J Clin Oncol (2012) 17: 491. doi:10.1007/s10147-011-0320-5
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Many clinical trials have been conducted with gemcitabine- or 5-fluorouracil-based regimens as treatment for unresectable biliary tract cancer; however, the results remain unsatisfactory. Because further therapeutic improvements are required, we conducted a phase I study of arterial infusion chemotherapy using a combination of gemcitabine and 5-fluorouracil.
In the first 3 cohorts, patients were to receive an arterial infusion of gemcitabine 600, 800 or 1000 mg/m2, respectively, over 30 min on days 1 and 15, plus a continuous arterial infusion of 5-fluorouracil 300 mg/m2/day on days 1–5 and 15–19. In the final cohort, patients were to receive an arterial infusion of gemcitabine 1000 mg/m2 over 30 min on days 1 and 15, plus 5-fluorouracil 400 mg/m2/day on days 1–5 and 15–19.
Eighteen patients were enrolled. In the final cohort, three of six patients experienced grade 3 non-hematological toxicities (cholecystitis, cellulitis and pneumonia). Thus, we determined the maximum tolerated doses of gemcitabine and 5-fluorouracil in arterial infusion chemotherapy to be 1000 and 400 mg/m2, respectively.
This regimen of gemcitabine and 5-fluorouracil is tolerable and warrants further investigation in biliary tract cancer.
KeywordsBiliary tract cancer Gemcitabine 5-Fluorouracil Arterial infusion chemotherapy Stent
Eastern Cooperative Oncology Group
Common hepatic artery
National Cancer Institute Common Toxicity Criteria
Granulocyte colony stimulating factor
Maximal tolerated dose
Expandable metallic stent