Abstract
Purpose
S-1 chemotherapy is effective against advanced biliary tract cancer. The purpose was to evaluate the efficacy and safety of S-1-based concurrent chemoradiotherapy in patients with advanced biliary tract cancer.
Methods
Patients with pathologically-proven advanced biliary tract cancer were eligible. S-1 was orally administered at a dose of 40 mg/m2, twice daily from day 1 to 14 and from day 22 to 35; concurrent radiotherapy of 180–200 cGy per fraction was delivered in 25–28 fractions. After treatment completion, tumor response was evaluated by computed tomography. In the first stage of the optimal two-stage phase II design, 18 patients were required.
Results
Twenty patients were enrolled between August 2006 and February 2009. The median age was 62.5 years (range 45–77 years). The median follow-up time was 11.6 months (range 1.9–49.1 months). Fifteen patients (75 %) had extrahepatic cholangiocarcinoma, two patients (10 %) had intrahepatic cholangiocarcinoma, and three patients (15 %) had gallbladder cancer. After treatment, a partial response was achieved in three patients (15 %), and stable disease was achieved in 14 patients (70 %). The overall response rate was 15 %, and the disease stabilization rate was 85 %. There was no grade 4 toxicity or treatment-related death. The common grade 3 toxicities were thrombocytopenia (15 %), neutropenia (10 %), and nausea (10 %). The median progression-free survival and median overall survival were 5.9 months (range 2.2–9.5 months) and 10.8 months (range 1.1–20.4 months), respectively.
Conclusions
This study shows that S-1-based concurrent chemoradiotherapy is feasible and tolerable in patients with advanced biliary tract cancer. It will be further confirmed in a following large-scale phase II study.
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H. M. Kim and K. J. Lee equally contributed to this work.
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Kim, H.M., Lee, K.J., Cha, J. et al. A pilot study of S-1-based concurrent chemoradiotherapy in patients with biliary tract cancer. Cancer Chemother Pharmacol 74, 861–865 (2014). https://doi.org/10.1007/s00280-014-2565-y
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DOI: https://doi.org/10.1007/s00280-014-2565-y