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Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas

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Abstract

Objectives

The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy.

Methods

The treatment consisted of cisplatin 70 mg/m2 in intravenous infusion followed by gemcitabine 1,250 mg/m2 in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity, patient’s refusal or up to 8 cycles.

Results

Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40%) had gall bladder cancer and 20 patients (57%) had cholangiocarcinoma. Thirty-two patients (91%) had metastatic disease at study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2% of the initially planned dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1% (95% CI; 4.7–29.6%). Ten patients (28.6%) had stable disease, 16 (45.7%) progressed, and three (8.6%) were not evaluable. For the 35 patients in the ITT population, the median overall survival time was 8.6 months (95% CI; 6.1–10.4 months). The median time to disease progression was 3.2 months (95% CI; 2.3–4.9 months) and the median time to treatment failure was 3.1 months (95% CI; 1.9–4.1 months). Among the six tumor responders, the median duration of tumor response was 7.3 months (95% CI; 5.6–11.0 months). The most common grade 3/4 maximum toxicities were nausea (3.4%) and vomiting (2.7%).

Conclusion

The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.

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Author notes

  1. Myung Ju Ahn & Ho Yeong Lim

    Present address: Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, South Korea

Authors and Affiliations

  1. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

    Jeeyun Lee

  2. Seoul National University Hospital, Seoul, South Korea

    Tae-You Kim

  3. Division of Hematology/Oncology, Catholic University Kangnam St. Mary’s Hospital, Seoul, South Korea

    Myung Ah Lee

  4. Department of Medicine, Hanyang University Hospital, Seoul, South Korea

    Myung Ju Ahn

  5. St. Vincent’s Hospital, Suwon, South Korea

    Hoon-Kyo Kim

  6. Department of Hematology-Oncology, Ajou University Medical Center, Suwon, Kyunggi, South Korea

    Ho Yeong Lim

  7. Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, South Korea

    Nam Su Lee

  8. Seoul National University, Seoul, South Korea

    Byung Joo Park

  9. Department of Medicine, Korea University Guro Hospital, 97 Gurodong-gil Gurogu, Seoul, 152-050, South Korea

    Jun Suk Kim

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  1. Jeeyun Lee
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on behalf of the Korean Cancer Study Group

Corresponding author

Correspondence to Jun Suk Kim.

Additional information

Supported by Korean Cancer Study Group.

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Lee, J., Kim, TY., Lee, M.A. et al. Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas. Cancer Chemother Pharmacol 61, 47–52 (2008). https://doi.org/10.1007/s00280-007-0444-5

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  • DOI: https://doi.org/10.1007/s00280-007-0444-5

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