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Erschienen in: Cancer Chemotherapy and Pharmacology 3/2019

06.12.2018 | Original Article

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

verfasst von: 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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 3/2019

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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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Metadaten
Titel
Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205)
verfasst von
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
Publikationsdatum
06.12.2018
Verlag
Springer Berlin Heidelberg
Erschienen in
Cancer Chemotherapy and Pharmacology / Ausgabe 3/2019
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-018-3739-9

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