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A phase II trial of biweekly oxaliplatin with simplified schedule of 48-h infusion of high-dose 5-fluorouracil and leucorvin for advanced biliary tract carcinoma

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Abstract

Purpose

Advanced biliary tract carcinoma (BTC) is a dismal disease with no standard chemotherapy. We investigated efficacy and toxicity of biweekly oxaliplatin with 48-h infusion of 5-FU/LV in advanced BTC.

Methods

All patients had histologic confirmation of BTC, at least one measurable site of disease, and had received no prior chemotherapy. Patients were older than 20 years with ECOG performance scores (PS) of 0–2. Treatment involved 2-h infusion of oxaliplatin (85 mg/m2) diluted in D5W 500 ml followed by 48-h infusion of 5-FU (3,000 mg/m2) and LV (100 mg/m2) biweekly. Response evaluation was based on RECIST criteria and was carried out every two courses of treatment; toxicity evaluation was based on NCI common toxicity criteria version 3.0.

Results

From August 2005 to December 2006, 34 chemotherapy-naive patients with advanced BTC were enrolled and 32 intention-to-treat patients were evaluated. Partial response was 18.8%, stable disease was 31.3%, resulting in a disease control rate of 50.0%. Median time to progression and survival was 3.7 and 7 months, respectively. The most common grade 3/4 toxicities were neutropenia 15.6% (5/32), stomatitis 9.4% (3/32), thrombocytopenia 6.3% (2/32), diarrhea 6.3% (2/32) and neuropathy 3.1% (1/32). No treatment-related deaths occurred.

Conclusions

The biweekly OXA and 48-h infusion of 5-FU/LV in patients with advanced BTC showed tolerable and efficacy equivalent to other combination regimens treatment.

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Acknowledgments

I would like to show my appreciation toward the patients who participated in this study and their families. I also would like to show my great gratitude to all dedicated investigators and research nurses. Finally, I would like to thank Mr. Taylor Hsu for his assistance for final furnishing of this paper and our statistics consultant Mr. Frank Hsu for his assistance in re-evaluating the data and offering statistics expert opinions.

Conflict of interest statement

None declared for the authors Jen-Shi Chen, Yee Chao, Tseng-Sheng Yang, Wen-Chi Chou, Li-Tzong Chen, Kuan-Der Lee, Yang-Chung Lin.

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Authors and Affiliations

  1. Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital (CGMH), Chang Gung University College of Medicine, 199 Dung-Hwa North Road, Taipei, Taiwan

    Jen-Shi Chen, Tseng-Sheng Yang, Wen-Chi Chou & Yang-Chung Lin

  2. Division of Gastrointestinology, Veterans General Hospital (VGH), Taipei, Taiwan

    Yee Chao

  3. Division of Cancer Research, National Health Research Institutes (NHRI), Taipei, Taiwan

    Li-Tzong Chen

  4. Division of Hematology-Oncology, Chang Gung Memorial Hospital, Chiayi, Taiwan

    Kuan-Der Lee

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  1. Jen-Shi Chen
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  2. Yee Chao
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  4. Wen-Chi Chou
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  5. Li-Tzong Chen
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  7. Yang-Chung Lin
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Correspondence to Jen-Shi Chen.

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Chen, JS., Chao, Y., Yang, TS. et al. A phase II trial of biweekly oxaliplatin with simplified schedule of 48-h infusion of high-dose 5-fluorouracil and leucorvin for advanced biliary tract carcinoma. Cancer Chemother Pharmacol 65, 151–157 (2009). https://doi.org/10.1007/s00280-009-1018-5

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  • DOI: https://doi.org/10.1007/s00280-009-1018-5

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