Zhang, R.X., Wu, X.J., Lu, S.X., Pan, Z.Z., Wan, D.S., & Chen, G. (2011). The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: A phase II randomized prospective study. Journal of Cancer Research and Clinical Oncology, 137, 953–957.
Capecitabine is hypothesized to cause overexpression of COX-2 in tumor and healthy tissue, inducing hand-foot syndrome (HFS). This prospective clinical trial will address whether the addition of a COX-2 inhibitor plus capecitabine can decrease or ease HFS.
Patients were randomly assigned to adjuvant treatment with capecitabine plus oxaliplatin or capecitabine alone, with or without celecoxib. The COX-2 inhibitor dose was 200 mg/m2 BID in combination with capecitabine for 14 days. Adverse events were monitored continuously during treatment and for 30 days after the last dose of study drug. The intensity of adverse events was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Patients were undergoing the active treatment phase of care.
This was a randomized, prospective phase 2 clinical trial.
HFS was evaluated according to the NCI CTCAE, version 4.0.
Celecoxib was safe and convenient for patients receiving chemotherapy and reduced the incidence of lower grade HFS.
In the correct population of patients, COX-2 inhibitors can be suggested. Additional research in this area is warranted.