Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205).
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.
['Suwa|Yusuke|Y|0000-0002-3738-9393', 'Watanabe|Jun|J|', 'Ota|Mitsuyoshi|M|', 'Suzuki|Shinsuke|S|', 'Suwa|Hirokazu|H|', 'Watanabe|Kazuteru|K|', 'Saito|Shuji|S|', 'Nagamine|Koutaro|K|', 'Momiyama|Masashi|M|', 'Ishibe|Atsushi|A|', 'Saigusa|Yusuke|Y|', 'Yamanaka|Takeharu|T|', 'Endo|Itaru|I|']
D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D000069287:Capecitabine D000068579:Celecoxib D017024:Chemotherapy, Adjuvant D015179:Colorectal Neoplasms D052246:Cyclooxygenase 2 Inhibitors D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D000077150:Oxaliplatin D010146:Pain D010147:Pain Measurement D016896:Treatment Outcome D014652:Vascular Diseases
Celecoxib Vascular pain Capeox Colon cancer Oxaliplatin