• Shiho Arima, Kyoko Shimizu, Tomoyoshi Okamoto, Masao Toki, Yutaka Suzuki, Naohiro Okano, Daisuke Naruge, Kirio Kawai, Takaaki Kobayashi, Akiyoshi Kasuga, Hiroshi Kitamura, Atuko Takasu, Fumio Nagashima, Masanori Sugiyama, and Junji Furuse.
• Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.
• Anticancer Res. 2017 Feb 1; 37 (2): 909-914.

BackgroundGemcitabine (GEM) plus cisplatin (CDDP) chemotherapy has been used worldwide as the standard first-line treatment for advanced biliary tract cancer (BTC). A phase II trial has also suggested promising activity of GEM plus S-1 chemotherapy against advanced BTC. The aim of this study was to evaluate the efficacy and safety of GEM plus S-1 chemotherapy in patients with advanced BTC.Patients And MethodsThe eligibility criteria were as follows: histologically-proven BTC, unresectable or recurrent disease, ECOG performance status (PS) 0-1 regardless of previous treatment. Gemcitabine was administered intravenously at the dose of 1,000 mg/m2 over 30 min on days 1 and 8, and S-1 was administered orally at doses of 60/80/100 mg/day based on the BSA, from day 1 to day 14, every 3 weeks. The primary endpoint was the response rate according to RECIST, ver. 1.1, and the secondary endpoints were the frequency/severity of toxicities, progression-free survival (PFS) and overall survival (OS).ResultsA total of 38 patients were enrolled between August 2008 and November 2011. There were 19 men and 19 women, with a median age of 66 years (range=44-81 years). Seven patients had a previous history of first-line or adjuvant chemotherapy after surgery. The PS was 0 and 1 in 30 and 7 patients, respectively. The treatment response was classified as partial response in 6 patients (15.8%) and as stable disease in 18 patients (47.4%). The median PFS and OS were 5.8 and 15.9 months, respectively. The toxicity was generally mild, and the most common grade 3/4 toxicities were leukopenia (31.6%), neutropenia (36.8%), nausea/vomiting (2.6%), and diarrhea (2.6%). There was one treatment-related death due to interstitial pneumonia.ConclusionOur study revealed that gemcitabine plus S-1 chemotherapy was well-tolerated and exhibited favorable antitumor activity in patients with advanced BTC.Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

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