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01-03-2019 | Original Article

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

Authors: Yusuke Suwa, Jun Watanabe, Mitsuyoshi Ota, Shinsuke Suzuki, Hirokazu Suwa, Kazuteru Watanabe, Shuji Saito, Koutaro Nagamine, Masashi Momiyama, Atsushi Ishibe, Yusuke Saigusa, Takeharu Yamanaka, Itaru Endo

Published in: Cancer Chemotherapy and Pharmacology | Issue 3/2019

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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Title: Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205)
Authors: Yusuke Suwa
Jun Watanabe
Mitsuyoshi Ota
Shinsuke Suzuki
Hirokazu Suwa
Kazuteru Watanabe
Shuji Saito
Koutaro Nagamine
Masashi Momiyama
Atsushi Ishibe
Yusuke Saigusa
Takeharu Yamanaka
Itaru Endo
Publication date: 01-03-2019
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 3/2019
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-018-3739-9

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