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Intravenous and Intraperitoneal Paclitaxel with S-1 for Refractory Pancreatic Cancer with Malignant Ascites: an Interim Analysis

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Abstract

Objectives

Here, we reported an interim analysis of feasibility and safety in the first 10 cases of 30 cases in a phase II trial of intravenous and intraperitoneal paclitaxel combined with S-1 for gemcitabine-refractory pancreatic cancer with malignant ascites.

Methods

Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8 every 3 weeks, and S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7-day rest.

Results

Between April 2011 and February 2012, ten patients were enrolled. A partial response was achieved in two patients (20 %) and a disease control rate of 50 %. The median time to progression and overall survival were 2.1 and 3.4 months, respectively. Malignant ascites was completely resolved in two patients (20 %). Major grade 3/4 adverse events were myelosuppression including neutropenia (50 %) and catheter-related infection (10 %).

Conclusions

This novel combination chemotherapy was feasible and showed promising results in pancreatic cancer patients with malignant ascites (clinical trial registration number: UMIN000005306).

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Acknowledgments

We thank the participating patients and their families, as well as the additional investigators and a research coordinator Miyuki Tsuchida (Clinical Research Support Center, The University of Tokyo Hospital).

Conflict of Interest

The authors have no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, , Bunkyo-ku, Tokyo, 113-8655, Japan

    Naminatsu Takahara, Hiroyuki Isayama, Yousuke Nakai, Takashi Sasaki, Tsuyoshi Hamada, Rie Uchino, Suguru Mizuno, Koji Miyabayashi, Dai Mohri, Kazumichi Kawakubo, Hirofumi Kogure, Natsuyo Yamamoto, Naoki Sasahira, Kenji Hirano, Hideaki Ijichi, Keisuke Tateishi, Minoru Tada & Kazuhiko Koike

  2. Department of Outpatient Chemotherapy, The University of Tokyo, Tokyo, Japan

    Hironori Ishigami

  3. Department of Surgical Oncology, The University of Tokyo, Tokyo, Japan

    Hironori Ishigami, Hiroharu Yamashita, Hironori Yamaguchi, Joji Kitayama & Toshiaki Watanabe

Authors
  1. Naminatsu Takahara
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  2. Hiroyuki Isayama
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  3. Yousuke Nakai
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  4. Takashi Sasaki
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  5. Hironori Ishigami
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  6. Hiroharu Yamashita
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  7. Hironori Yamaguchi
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  8. Tsuyoshi Hamada
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  9. Rie Uchino
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  10. Suguru Mizuno
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  11. Koji Miyabayashi
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  12. Dai Mohri
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  13. Kazumichi Kawakubo
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  14. Hirofumi Kogure
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  15. Natsuyo Yamamoto
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  16. Naoki Sasahira
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  17. Kenji Hirano
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  18. Hideaki Ijichi
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  19. Keisuke Tateishi
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  20. Minoru Tada
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  21. Joji Kitayama
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  22. Toshiaki Watanabe
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  23. Kazuhiko Koike
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Corresponding author

Correspondence to Hiroyuki Isayama.

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Takahara, N., Isayama, H., Nakai, Y. et al. Intravenous and Intraperitoneal Paclitaxel with S-1 for Refractory Pancreatic Cancer with Malignant Ascites: an Interim Analysis. J Gastrointest Canc 45, 307–311 (2014). https://doi.org/10.1007/s12029-014-9603-1

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  • DOI: https://doi.org/10.1007/s12029-014-9603-1

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