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Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205)

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Abstract

Purpose

Capeox is widely used as an adjuvant chemotherapy regimen of colorectal cancer that does not require central vein catheter insertion. However, oxaliplatin-related vascular pain with peripheral administration is a major adverse event. We assessed the preventive effect of Celecoxib on oxaliplatin-related vascular pain.

Methods

A multicenter study of the Yokohama Clinical Oncology Group (YCOG) in Japan. This study was an open label, randomized non-comparative phase II study between Capeox without Celecoxib (C+ Group) and with it (C− group). The primary endpoint was the appearance frequency of grade ≥ 2 vascular pain according to the Verbal Rating Scale (VRS).

Results

Between October 2012 and February 2014, 81 patients were recruited to this study and randomly divided into 2 groups: 38 patients in the C− group and 39 patients in the C+ group. Four cases were excluded at the analysis stage because they had not received the allocated intervention. The rate of grade ≥ 2 vascular pain was 55.3% in the C− group and 53.8% in the C+ group (p = 1.000).

Conclusions

Celecoxib was unable to prevent oxaliplatin-related vascular pain in this study. However, it may be able to decrease the vascular pain that patients already have.

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Acknowledgements

I wish to thank all of the doctors, pharmacists, and nurses concerned with this trial.

Author information

Authors and Affiliations

  1. Department of Gastroenterological Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan

    Yusuke Suwa, Shinsuke Suzuki, Atsushi Ishibe & Itaru Endo

  2. Gastroenterological Center, Yokohama City University Medical Center, 4-57 Urafune, Minamiku, Yokohama, Kanagawa, Japan

    Jun Watanabe & Mitsuyoshi Ota

  3. Department of Surgery, Yokosuka Kyosai Hospital, 1-16 Yonegahamadori, Yokosuka, Kanagawa, Japan

    Hirokazu Suwa

  4. Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashigotanda, Shinagawaku, Tokyo, Japan

    Kazuteru Watanabe & Masashi Momiyama

  5. Department of Surgery, National Hospital Organization Yokohama Medical Center, 3-60-2 Harajyuku, Totsukaku, Yokohama, Kanagawa, Japan

    Shuji Saito

  6. Department of Surgery, Yokosuka Municipal Citizen’s Hospital, 1-3-2 Nagasaka, Yokosuka, Kanagawa, Japan

    Koutaro Nagamine

  7. Department of Biostatistics, Yokohama City University, 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan

    Yusuke Saigusa & Takeharu Yamanaka

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  1. Yusuke Suwa
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  2. Jun Watanabe
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  5. Hirokazu Suwa
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  8. Koutaro Nagamine
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  9. Masashi Momiyama
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  10. Atsushi Ishibe
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  11. Yusuke Saigusa
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Corresponding author

Correspondence to Yusuke Suwa.

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Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Suwa, Y., Watanabe, J., Ota, M. et al. Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205). Cancer Chemother Pharmacol 83, 419–424 (2019). https://doi.org/10.1007/s00280-018-3739-9

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  • DOI: https://doi.org/10.1007/s00280-018-3739-9

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