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A phase II study of uracil-tegafur plus doxorubicin and prognostic factors in patients with unresectable biliary tract cancer

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Abstract

Purpose

The purpose of this study was to clarify the safety and efficacy of combination chemotherapy of uracil-tegafur (UFT) and doxorubicin (UFD regimen), and to identify the prognostic factors in patients with unresectable advanced biliary tract cancer who received systemic chemotherapy.

Methods

Patients with histologically or cytologically confirmed, measurable biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary cancer, who were not suitable candidates for surgery, were eligible for the study. Patients received oral UFT at 300 mg/m2 per day divided into two doses on days 1–14 and intravenous doxorubicin at 30 mg/m2 on day 1. This cycle was repeated every 21 days. The relationship between the patient characteristics and the prognosis was examined. Univariate and multivariate analyses were conducted to identify the prognostic factors associated with survival.

Results

Sixty-one patients from 12 institutions were enrolled in the late phase II study between April 2005 and March 2006. Of the 61 patients, 4 patients had partial responses, for an objective response rate of 6.6% (95% CI: 1.8–15.9%); 28 patients had stable disease, 27 had progressive diseases, and 2 patients were not evaluated. The median progression-free survival was 1.6 months, and the overall median survival time was 6.5 months. In the 85 patients who received this UFD chemotherapy in previous and late phase II studies, multivariate analysis revealed the ECOG performance status 1 (P = 0.001), gallbladder as the primary cancer site (P = 0.014), T-factor 4 of the TNM classification (P = 0.035), and elevated serum lactate dehydrogenase levels (P = 0.043) as being associated with a significantly shorter survival.

Conclusions

Combination chemotherapy of UFT and doxorubicin had minimum activity against advanced biliary tract cancer. Performance status was identified as the most important prognostic factor in patients who received systemic chemotherapy.

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Acknowledgments

This study was supported in part by Grants-in-Aid for Cancer Research from the Ministry of Health, Labour, and Welfare of Japan.

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Authors and Affiliations

  1. Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

    Junji Furuse

  2. Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan

    Takuji Okusaka

  3. Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama, Japan

    Shinichi Ohkawa

  4. Department of Imaging Diagnosis, Tochigi Cancer Center, Utsunomiya, Japan

    Michitaka Nagase

  5. Department of Gastroenterology, National Kyushu Cancer Center, Fukuoka, Japan

    Akihiro Funakoshi

  6. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Suntou-gun, Shizuoka, Japan

    Narikazu Boku

  7. Department of Gastroenterology, Aichi Cancer Center, Nagoya, Japan

    Kenji Yamao

  8. Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan

    Taketo Yamaguchi

  9. Department of Biostatistics, Kyoto University School of Public Health, Kyoto, Japan

    Toshiya Sato

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

    Junji Furuse

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  1. Junji Furuse
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  2. Takuji Okusaka
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  4. Michitaka Nagase
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  5. Akihiro Funakoshi
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  6. Narikazu Boku
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  7. Kenji Yamao
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  8. Taketo Yamaguchi
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  9. Toshiya Sato
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Correspondence to Junji Furuse.

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Furuse, J., Okusaka, T., Ohkawa, S. et al. A phase II study of uracil-tegafur plus doxorubicin and prognostic factors in patients with unresectable biliary tract cancer. Cancer Chemother Pharmacol 65, 113–120 (2009). https://doi.org/10.1007/s00280-009-1011-z

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  • DOI: https://doi.org/10.1007/s00280-009-1011-z

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