Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine
- 461 Downloads
Gemcitabine is widely used for the treatment of advanced biliary tract cancer (BTC) as first-line chemotherapy. However, there is no standard chemotherapy for patient with advanced BTC refractory to gemcitabine. We conducted a multicenter phase II study of S-1 monotherapy as second-line chemotherapy for patients with advanced BTC that were refractory to gemcitabine. S-1 was administered orally at a dose of 80 mg/m2 for 28 days, followed by 14 days of rest. This regimen was repeated every 6 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty-two patients were enrolled between March 2007 and January 2010, with 14 patients (64%) representing cases of recurrence after surgery. The overall response rate was 22.7%, and the overall disease control rate was 50.0%. The median overall survival time was 13.5 months (95% CI, 7.1–23.1 months) and the median time-to-progression was 5.4 months (95% CI, 2.6–17.2 months). Grade 3/4 toxicities included neutropenia (5%) and anemia (5%). The most common non-hematological toxicities were nausea (27%), anorexia (55%), and pigmentation (32%). In conclusion, S-1 monotherapy is feasible and moderately efficacious second-line chemotherapy for advanced BTC.
KeywordsBiliary tract cancer S-1 Gemcitabine Second-line
Conflict of interest statement
- 1.National Cancer Center. Cancer statistics in Japan 2009. http://www.fpcr.or.jp/publication/statistics.html. Accessed 1 August, 2010.
- 10.Oh SY, Jeong CY, Hong SC, Kim TH, Ha CY, Kim HJ, et al. Phase II study of second line gemcitabine single chemotherapy for biliary tract cancer patients with 5-fluorouracil refractoriness. Invest New Drugs 2010 (in press).Google Scholar
- 11.Sasaki T, Isayama H, Nakai Y, Mizuno S, Yamamoto K, Yagioka H et al (2010) Feasibility study of gemcitabine and cisplatin combination chemotherapy for patients with refractory biliary tract cancer. Invest New Drugs (in press).Google Scholar
- 16.Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92(3):205–216PubMedCrossRefGoogle Scholar
- 18.Suzuki E, Ikeda M, Okusaka T, Nakamori S, Ohkawa S, Nagakawa T et al (2010) A multicenter phase II of S-1 in gemcitabine-refractory biliary tract cancer. Proc Am Soc Clin Oncol 28:15s, abstract no: 4145Google Scholar
- 20.Sasaki T, Isayama H, Nakai Y, Togawa O, Kogure H, Ito Y et al (2010) Prognostic factors in patientswith advanced biliary tract cancer receiving chemotherapy. Cancer Chemother Pharmacol (in press)Google Scholar