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Phase II study of mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) as second-line treatment after gemcitabine failure in patients with unresectable/metastatic biliary tract cancer

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Abstract

Purpose

We conducted a phase II trial of 5-fluorouracil and oxaliplatin combination chemotherapy as a second-line treatment in unresectable/metastatic biliary tract cancer patients who had failed gemcitabine-based chemotherapy.

Methods

Patients treated with gemcitabine-based palliative treatment were enrolled in this study. Patients were received modified FOLFOX3 (mFOLFOX3) consists of oxaliplatin 85 mg/m2 (day 1) and leucovorin 30 mg (days 1, 2) followed by 5-fluorouracil 1,500 mg/m2 (days 1, 2) every 2 weeks.

Results

Between March 2010 and June 2012, a total of 30 patients were enrolled in this study. Twenty-eight patients were measurable for treatment response. One achieved complete response, and one a partial response was observed. Overall response rate was 7.1 % (95 % confidence interval 0.9–23.5 %). The median progression-free survival was 1.6 months, and the median overall survival was 4.4 months. Grade 3–4 hematologic toxicities included neutropenia (6.7 %) and thrombocytopenia (3.4 %). The most common non-hematologic toxicity was neuropathy (22.2 %). However, the most common grade 3–4 non-hematologic toxicity was hyperbilirubinemia (5.0 %). There was one treatment-related death due to neutropenic infection.

Conclusion

mFOLFOX3 as a second-line regimen has modest effect and tolerable toxicity in unresectable/metastatic biliary tract cancer patients who have been treated previously via gemcitabine-based chemotherapy.

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Acknowledgments

This work was supported by Jeil pharmaceutical Co., Seoul, Korea. We gratefully acknowledge the outstanding support and assistance of Ms. Eun-Hee Cho, an assistant nurse, for data management.

Conflict of interest

Conflict of interest relevant to this article was not reported.

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Author notes

    Authors and Affiliations

    1. Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 224 Heukseok-dong, Dongjak-gu, Seoul, 156-755, Korea

      In Gyu Hwang & Joung-Soon Jang

    2. Department of Internal Medicine, Dong-A University College of Medicine, 26 Daesingongwon-ro, Seo-gu, Busan, 602-715, Korea

      Sung Yong Oh, Myung Hwan Rho & Suee Lee

    3. Department of Internal Medicine, Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, 135-710, Korea

      Young Suk Park & Joon Oh Park

    4. Department of Internal Medicine, Ewha Womans University College of Medicine, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul, 158-710, Korea

      Eun Mi Nam

    5. Department of Internal Medicine, Korea Cancer Center Hospital, 75, Nowon-ro, Nowon-gu, Seoul, 139-706, Korea

      Hyo Rak Lee

    6. Department of Internal Medicine, Seoul Medical Center, 156, Sinnae-ro, Jungnang-gu, Seoul, 131-795, Korea

      Hyun Jung Jun

    7. Department of Surgery, Chung-Ang University College of Medicine, 224 Heukseok-dong, Dongjak-gu, Seoul, 156-755, Korea

      Kyong-Choun Chi

    8. Department of Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 102 Heukseok-ro, Dongjak-gu, Seoul, 156-755, Korea

      Kyong-Choun Chi

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    1. In Gyu Hwang
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    Correspondence to Joung-Soon Jang or Kyong-Choun Chi.

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    In Gyu Hwang and Sung Yong Oh have contributed equally to this article.

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    Hwang, I.G., Jang, JS., Oh, S.Y. et al. Phase II study of mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) as second-line treatment after gemcitabine failure in patients with unresectable/metastatic biliary tract cancer. Cancer Chemother Pharmacol 75, 757–762 (2015). https://doi.org/10.1007/s00280-015-2691-1

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