Cancer Chemother Pharmacol. 2013 May;71(5):1141-6. doi: 10.1007/s00280-013-2106-0.

A multicenter phase II study of S-1 for gemcitabine-refractory biliary tract cancer.

Suzuki E, Ikeda M, Okusaka T, Nakamori S, Ohkawa S, Nagakawa T, Boku N, Yanagimoto H, Sato T, Furuse J.

Department of Internal Medicine, Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo 181-8611, Japan.



PURPOSE: Gemcitabine (GEM)-based chemotherapy has been used worldwide as the first-line treatment for advanced biliary tract cancer (BTC). However, no standard regimens have been established yet for patients with GEM-refractory BTC. A previous phase II trial of S-1 as a first-line treatment in patients with advanced BTC revealed promising activity of this drug. The present study was conducted to evaluate the efficacy and safety of S-1 in patients with GEM-refractory BTC.

METHODS: The subjects were patients with pathologically proven BTC who had shown disease progression while receiving GEM-based chemotherapy. Each treatment cycle consisted of administration of S-1 orally at the dose of 40 mg/m(2) twice daily for 28 days, followed by a rest period of 14 days. The primary endpoint of this study was objective response, and the secondary endpoints were the toxicity, progression-free survival (PFS), and overall survival (OS).

RESULTS: Forty patients were assessed for efficacy and safety from 8 hospitals in Japan between June 2007 and September 2008. There were 3 cases of confirmed partial response (7.5 %) and 22 patients (55 %) of stable disease. The median PFS and OS were 2.5 and 6.8 months, respectively. Toxicity was generally mild, and the most common grade 3 or 4 toxicities were anorexia (10.0 %), anemia (7.5 %), mucositis (7.5 %), hypoalbuminemia (5.0 %), and pneumonia (5.0 %). There were no treatment-related deaths.

CONCLUSIONS: Monotherapy with S-1 was well tolerated, but showed modest efficacy in patients with GEM-refractory BTC.

PMID: 23525694

Eiichiro Suzuki- fig1Progression-free survival (dash line) and overall survival (solid line) curves of patients with gemcitabine-refractory biliary tract cancer receiving systemic chemotherapy with S-1.

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