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Japanese Journal of Clinical Oncology 2005 35(2):68-73; doi:10.1093/jjco/hyi021
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© 2005 Foundation for Promotion of Cancer Research

Single-agent Gemcitabine in the Treatment of Advanced Biliary Tract Cancers: a Phase II Study

Jong-Sung Park1, Sung-Yong Oh1, Sung-Hyun Kim1, Hyuk-Chan Kwon1, Jae-Seok Kim1, Hyo Jin-Kim1 and Young-Hoon Kim2

1 Department of Internal Medicine and 2 Department of Surgery, Dong-A University Hospital, Busan, Korea

For reprints and all correspondence: Hyo-Jin Kim, Department of Internal Medicine, Dong-A University Hospital, 3-1 Dongdaeshin dong, Seo-gu, Busan, 602-715, Republic of Korea. E-mail: kimhj{at}mail.donga.ac.kr

Received September 2, 2004; accepted December 4, 2004

Objective: Patients with advanced biliary tract cancers have a dismal prognosis. The aim of this study was to evaluate the efficacy and safety of gemcitabine as a single agent in the treatment of patients with unresectable biliary tract cancers.

Methods: From May 2002 to April 2004, 23 chemotherapy-naïve patients with locally advanced or metastatic biliary tract adenocarcinomas were enrolled. The median age was 59 years (range 37–76). Fifteen patients (65.2%) had cholangiocarcinomas and eight (34.8%) had gallbladder adenocarcinomas. Patients received gemcitabine 1000 mg/m2 over 60 min once a week for 2 weeks followed by a week off therapy. Treatment was discontinued when unacceptable toxicities occurred or there was evidence of disease progression.

Results: A total of 110 cycles of chemotherapy were performed with a median of four cycles (range 1–10). The median follow-up was 13.4 months. Among the 23 patients, six (26.1%) had a partial response, eight (34.8%) had stable disease and nine (39.1%) had disease progression despite treatment. The overall response rate was 26.1% [95% confidence interval (CI) 22.08–30.12]. The median time to disease progression was 8.1 months (95% CI 3.33–12.87) and the median overall survival was 13.1 months (95% CI 1.64–24.56). Toxicities were generally mild and treatment was well tolerated. Of the 23 patients, one patient experienced a grade 3–4 neutropenia and one a grade 3–4 thrombocytopenia; however, no cases of febrile neutropenia or treatment-related deaths were noted.

Conclusion: In this phase II trial, therapy with gemcitabine was well tolerated and clinically active in patients with locally advanced or metastatic biliary tract cancers.

Key Words: gemcitabine • biliary tract cancer • cholangiocarcinoma


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