title: Celecoxib can prevent capecitabine-related hand-foot syndrome in stage II and III colorectal cancer patients: result of a single-center, prospective randomized phase III trial.
abstract: BACKGROUND
  Hand-foot syndrome (HFS) is the most common adverse event induced by capecitabine. Some clinicians think that HFS is a type of inflammation limited to the hands and feet and can be prevented with a COX-2 inhibitor (celecoxib).
  
  
  METHODS
  We designed a single-center, prospective randomized clinical trial to test the hypothesis. From August 2008 to December 2010, stage II and III colorectal cancer patients receiving capecitabine-based chemotherapy enrolled in the trial voluntarily. All patients were divided randomly into two groups treated with or without celecoxib. All adverse events were recorded.
  
  
  RESULTS
  Grade 1 and grade 2 HFS were more common in the capecitabine group than in the capecitabine/celecoxib group (74.6% versus 57.4%, P = 0.034, 29.6% versus 14.7% P = 0.035). The use of celecoxib (P < 0.001, P = 0.003) and the level of dihydropyrimidine dehydrogenase (P = 0.048, P = 0.014) affected the incidence of grade 1 and 2 HFS, as determined by log-rank analysis. Multivariate Cox proportional hazards regression analysis indicated that the use of celecoxib was the only factor that affected the incidence of ≥ grade 1 HFS [Hazard Ratio (HR): 0.556, P = 0.001] and ≥ grade 2 HFS (HR: 0.414, P = 0.005).
  
  
  CONCLUSIONS
  Celecoxib can be used effectively and safely to prevent capecitabine-related HFS.
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
authors.forename: R X
authors.initials: RX
authors.lastname: Zhang
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
authors.forename: X J
authors.initials: XJ
authors.lastname: Wu
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
authors.forename: D S
authors.initials: DS
authors.lastname: Wan
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
authors.forename: Z H
authors.initials: ZH
authors.lastname: Lu
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
authors.forename: L H
authors.initials: LH
authors.lastname: Kong
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China. Electronic address: chengong@sysucc.org.cn.
authors.forename: Z Z
authors.initials: ZZ
authors.lastname: Pan
authors.affiliation: Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong; State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, People's Republic of China.
authors.forename: G
authors.initials: G
authors.lastname: Chen
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000465:Algorithms; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000069287:Capecitabine; D000068579:Celecoxib; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000494:pharmacology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D060831:Hand-Foot Syndrome / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage / Q000494:pharmacology*; D013449:Sulfonamides / Q000008:administration & dosage / Q000494:pharmacology*
chemical_list: D000964:Antimetabolites, Antineoplastic; D052246:Cyclooxygenase 2 Inhibitors; D004338:Drug Combinations; D011720:Pyrazoles; D013449:Sulfonamides; D003841:Deoxycytidine; D000069287:Capecitabine; D000068579:Celecoxib; D005472:Fluorouracil