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Phase II study of 5-fluorouracil and paclitaxel in patients with gemcitabine-refractory pancreatic cancer

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Abstract

Purpose

There is no effective salvage regimen for failed gemcitabine-based chemotherapy. This study evaluated the efficacy and toxicity of 5-fluorouracil and paclitaxel in patients with gemcitabine-refractory pancreatic cancer.

Methods

Between January 2004 and December 2007, 28 patients with pancreatic cancer previously treated with gemcitabine-based chemotherapy were enrolled. 5-Fluorouracil 1,000 mg/m2 was infused (days 1, 2, and 3) and paclitaxel 175 mg/m2 (day 1) was administered every 4 weeks. The primary endpoint of this study was efficacy and toxicity and the secondary endpoint was time to progression and overall survival.

Results

A total of 75 cycles were given, for a mean of 2.68 cycles per patient. The response could be evaluated in 20 patients. Two patients (10%) obtained a partial response, and four patients (20%) had stable disease. The median time to progression and overall survival was 2.5 and 7.6 months, respectively.

Grade 3/4 hematological toxicity included neutropenia in six patients (21.4%), anemia in one (3.6%), and thrombocytopenia in one (3.6%). One (3.6%) patient experienced grade 4 neuropathy, and two (7.2%) patients experienced grade 3 diarrhea.

Conclusion

The 5-fluorouracil and paclitaxel combination treatment seems to be effective in patients with advanced pancreatic cancer that did not respond to a gemcitabine-based regimen.

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Authors and Affiliations

  1. Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-gu, Seoul, 120-752, South Korea

    Yoon Jae Kim, Seungmin Bang, Jeong Youp Park, Seung Woo Park, Jae Bock Chung & Si Young Song

  2. Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine, Seoul, South Korea

    Si Young Song

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  1. Yoon Jae Kim
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  2. Seungmin Bang
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  3. Jeong Youp Park
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  4. Seung Woo Park
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  5. Jae Bock Chung
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  6. Si Young Song
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Correspondence to Si Young Song.

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Kim, Y.J., Bang, S., Park, J.Y. et al. Phase II study of 5-fluorouracil and paclitaxel in patients with gemcitabine-refractory pancreatic cancer. Cancer Chemother Pharmacol 63, 529–533 (2009). https://doi.org/10.1007/s00280-008-0822-7

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  • DOI: https://doi.org/10.1007/s00280-008-0822-7

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