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Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients

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Abstract

Purpose

Biliary tract cancer (BTC) is a heterogeneous group of diseases comprising intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer. Although gemcitabine plus cisplatin (GEMCIS) was established as the standard first-line chemotherapy based on the ABC-02 trial, more data are needed to define the clinical course of BTC and its prognostic factors with the standard GEMCIS treatment.

Methods

Between April 2010 and June 2016, 740 patients with histologically documented cholangiocarcinoma and gallbladder cancer were treated with first-line GEMCIS in Asan Medical Center, Seoul, Korea.

Results

In 389 patients with measurable disease (53%), the objective response rate was 13% (n = 50) and there was no significant difference between primary tumor sites (p = 0.45). With a median follow-up duration of 27.3 months (95% CI 24.2–30.5), the median PFS and OS were 5.2 months (95% CI 4.7–5.6) and 10.4 months (95% CI 9.6–11.2), respectively. In multivariate analysis, male gender (female versus male, hazard ratio [HR] 0.83), baseline CA 19-9 level (elevated versus normal, HR 1.31), initially metastatic disease (versus locally advanced disease, HR 1.92), poor performance status (2 versus 0–1, HR 1.45), and measurable disease by RECIST criteria (versus non-measurable, HR 1.40) were significantly associated with a poorer OS (all p < 0.05).

Conclusions

Our retrospective analysis of a large number of patients in a real-world setting found comparable efficacy outcomes to the ABC-02 trial. The prognostic factors identified here may help to predict clinical outcomes and design future clinical trials for advanced BTC.

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Author information

Author notes

  1. Bum Jun Kim and Jaewon Hyung contributed equally to this work and should be considered co-first authors.

  2. Changhoon Yoo and Heung-Moon Chang contributed equally to this work and should be considered co-corresponding authors.

Authors and Affiliations

  1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea

    Bum Jun Kim, Jaewon Hyung, Changhoon Yoo, Kyu-pyo Kim, Seong-Joon Park, Hyungwoo Cho, Baek-Yeol Ryoo & Heung-Moon Chang

  2. Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Sang Soo Lee, Do Hyun Park, Tae Jun Song, Dong Wan Seo, Sung Koo Lee & Myung-Hwan Kim

  3. Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Jin-hong Park

  4. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Seoul, Republic of Korea

    Bum Jun Kim

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  1. Bum Jun Kim
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Corresponding authors

Correspondence to Changhoon Yoo or Heung-Moon Chang.

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Conflict of interest

All authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

IRB waived informed consent for this study because of its nature of retrospective analysis.

Funding

This study was supported in part by the Bio and Medical Technology Development Program of the NRF funded by the Korean government, MSIP (NRF-2016M3A9E8941331).

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Kim, B.J., Hyung, J., Yoo, C. et al. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol 80, 209–215 (2017). https://doi.org/10.1007/s00280-017-3353-2

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  • DOI: https://doi.org/10.1007/s00280-017-3353-2

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