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Hepatic Arterial Infusion with Oxaliplatin and 5-FU/Folinic Acid for Advanced Biliary Tract Cancer: A Phase II Study

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Abstract

Background

Effective and tolerable chemotherapy with gemcitabine and cisplatin for advanced biliary tract cancer (BTC) has been established recently. However, overall prognosis is still poor, and additional therapeutic approaches are needed for patients with locally advanced, irresectable and/or pretreated tumors. Hepatic arterial infusion (HAI) of chemotherapy represents a safe and well-established treatment modality, but data on its use in patients with BTC are still sparse.

Methods

Patients with irresectable BTC predominant to the liver were included in a prospective, open phase II study investigating HAI provided through interventionally implanted port catheters. Intraarterial chemotherapy consisted of biweekly oxaliplatin (O) 85 mg/m2 and folinic acid (F) 170 mg/m2 with 5-FU (F) 600 mg/m2.

Results

Between 2004 and 2010, 37 patients were enrolled. A total of 432 cycles of HAI were applied with a median of 9 (range 1–46) cycles. Objective response rate was 16 %, and tumor control was achieved in 24 of 37 (65 %) patients. Median progression-free survival was 6.5 months (range 0.5–26.0; 95 % CI 4.3–8.7), median overall survival was 13.5 (range 0.9–50.7; 95 % CI 11.1–15.9) months. The most frequent adverse event was sensory neuropathy grade 1/2 in 10/14 patients.

Conclusions

Using a minimal invasive technique, repetitive HAI with OFF is feasible and results in clinically relevant tumor control with low toxicity in patients with liver predominant advanced BTC.

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Acknowledgments

This work was supported in part by a grant from Sanofi-Aventis, Deutschland, Frankfurt. Sanofi-Aventis Deutschland had no role in the design and conduct of the trial nor the collection, analysis or interpretation of data.

Conflict of interest

Bernhard Gebauer received a speaker’s fee by C.R. Bard. Bert Hildebrandt has received honoraria (below 10,000 Euro each) from Amgen, Merck and Roche, and has been involved into the conduction of trials sponsored by Amgen, Merck, Roche, and Sanofi-Aventis. All remaining authors have declared no conflicts of interest.

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Authors and Affiliations

  1. Department of Medical Oncology and Haematology, Charité-School of Medicine Berlin, Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany

    M. Sinn, B. Dörken, H. Riess & B. Hildebrandt

  2. Department of Haematology and Oncology, University Medicine Schleswig–Holstein, Kiel, Germany

    A. Nicolaou & P. Podrabsky

  3. Department of Radiology, Charité-School of Medicine Berlin, Berlin, Germany

    B. Gebauer & D. Seehofer

  4. Department of General, Visceral and Transplantation Surgery, Charité-School of Medicine Berlin, Berlin, Germany

    P. Podrabsky, D. Seehofer, J. Ricke, B. Dörken, H. Riess & B. Hildebrandt

  5. Department of Radiology and Nuclear Medicine, Otto-von-Guericke-University, Magdeburg, Germany

    J. Ricke

Authors
  1. M. Sinn
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  2. A. Nicolaou
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  3. B. Gebauer
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  4. P. Podrabsky
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  5. D. Seehofer
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  6. J. Ricke
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  7. B. Dörken
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  8. H. Riess
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  9. B. Hildebrandt
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Corresponding author

Correspondence to M. Sinn.

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Sinn, M., Nicolaou, A., Gebauer, B. et al. Hepatic Arterial Infusion with Oxaliplatin and 5-FU/Folinic Acid for Advanced Biliary Tract Cancer: A Phase II Study. Dig Dis Sci 58, 2399–2405 (2013). https://doi.org/10.1007/s10620-013-2624-y

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  • DOI: https://doi.org/10.1007/s10620-013-2624-y

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