Abstract
Purpose
To date, gemcitabine-based or fluoropyrimidine-based regimens are recommended for unresectable advanced biliary tract cancer. Then, we conducted a phase I study of gemcitabine/cisplatin and S-1 that is an oral fluoropyrimidine. The aim of this study was to determine the dose-limiting toxicity (DLT), maximum-tolerated dose, and a recommended phase II dose of S-1. Response was assessed as a secondary endpoint.
Patients and methods
Patients who have been diagnosed with unresectable or postoperative recurrent biliary tract cancer received cisplatin (25 mg/m2 i.v. for 120 min) followed by gemcitabine (1,000 mg/m2 i.v. for 30 min) on days 1 and 8, and oral S-1 on alternate days; this regimen was repeated at 21-day intervals. A standard ‘3 + 3’ phase I dose-escalation design was adopted. This study was registered with University hospital Medical Information Network (UMIN) Center in Japan, number UMIN000008415.
Results
Twelve patients were evaluable in this study. No patients developed DLTs. Recommended dose of S-1 was 80 (<1.25 m2), 100 (1.25 ≤ 1.5 m2), and 120 mg (1.5 m2≥) per day. One patient could achieve conversion to curative surgery.
Conclusion
This phase I study was performed safely and demonstrated encouraging response.
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Acknowledgments
The authors thank all patients who consented to participate in this study and nurses who took care of patients at the outpatient section of our departments.
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The authors declare that there are no conflicts of interest.
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Uwagawa, T., Sakamoto, T., Abe, K. et al. Phase I trial of S-1 every other day in combination with gemcitabine/cisplatin for inoperable biliary tract cancer. Cancer Chemother Pharmacol 75, 191–196 (2015). https://doi.org/10.1007/s00280-014-2636-0
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DOI: https://doi.org/10.1007/s00280-014-2636-0