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Phase II study of single-agent gemcitabine in patients with advanced biliary tract cancer

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Abstract

Purpose: This phase II study was conducted to evaluate the efficacy and toxicity of single-agent gemcitabine in patients with advanced or metastatic biliary tract cancer. Patients and methods: Gemcitabine 1,000 mg/m2 was administered as an intravenous 30-min infusion on days 1, 8, and 15 for every 28 days. Results: Forty chemonaive patients with a median age of 61 (range 33–73) were enrolled, and all 40 patients were involved in efficacy and safety analyses. Seven (17.5%) achieved partial response; 15 (37.5%) had stable disease; 17 (42.5%) had progressive disease; and 1 (2.5%) was not evaluated. The median survival time was 7.6 months, and the 1-year survival rate was 25.0%. Grade 3/4 neutropenia occurred in 12 patients (30.0%), leukopenia in five patients (12.5%), and anemia in four patients (10.0%). The most common grade 3/4 nonhematologic toxicities were elevated ALT (15.0%) and elevated γ-GTP (12.5%). One patient had grade 4 hemolytic uremic syndrome and recovered after discontinuation of gemcitabine. Conclusions: In single-agent therapy, gemcitabine demonstrated moderate efficacy with manageable toxicity in patients with advanced or metastatic biliary tract cancer. Further evaluations are warranted, including the exact impact of gemcitabine on the management of advanced or metastatic biliary tract cancer.

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Acknowledgements

This study was supported by Eli Lilly Japan who also supplied gemcitabine. We thank Ms. Keiko Kondo for her great help in manuscript preparation.

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Authors and Affiliations

  1. Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Takuji Okusaka

  2. National Cancer Center Hospital East, Chiba, Japan

    Hiroshi Ishii

  3. National Kyushu Cancer Center, Fukuoka, Japan

    Akihiro Funakoshi

  4. Aichi Cancer Center, Nagoya, Japan

    Kenji Yamao

  5. Kanagawa Cancer Center Hospital, Yokohama, Japan

    Shinichi Ohkawa

  6. Aomori Prefectural Central Hospital, Aomori, Japan

    Soh Saito

  7. Yamagata Prefectural Central Hospital, Yamagata, Japan

    Hiroshi Saito

  8. Chiba University Hospital, Chiba, Japan

    Toshio Tsuyuguchi

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  1. Takuji Okusaka
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  3. Akihiro Funakoshi
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Correspondence to Takuji Okusaka.

Appendix

Appendix

Case Judgment Committee

Minoru Kurihara, The Tokyo Cooperative Oncology Group

Seiki Matsuno, Tohoku University Hospital

Noriyuki Moriyama, National Cancer Center

Efficacy and Safety Evaluation Committee

Shigeru Tsukagoshi, The Tokyo Cooperative Oncology Group

Toshifusa Nakajima, Cancer Research/Cancer Chemotherapy Center

Shoji Kudo, Nippon Medical School Hospital

Advisor for Efficacy Evaluation

Tetsuo Taguchi, Japan Society for Cancer Chemotherapy

Advisor for Medical Statistics

Yasuo Ohashi, The University of Tokyo

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Okusaka, T., Ishii, H., Funakoshi, A. et al. Phase II study of single-agent gemcitabine in patients with advanced biliary tract cancer. Cancer Chemother Pharmacol 57, 647–653 (2006). https://doi.org/10.1007/s00280-005-0095-3

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  • DOI: https://doi.org/10.1007/s00280-005-0095-3

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