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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.
Ann Oncol 2012; 23(5):1348-53AO

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+Show Affiliations

Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21940785

Citation

Zhang, R X., et al. "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." Annals of Oncology : Official Journal of the European Society for Medical Oncology, vol. 23, no. 5, 2012, pp. 1348-53.
Zhang RX, Wu XJ, Wan DS, et al. 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. Ann Oncol. 2012;23(5):1348-53.
Zhang, R. X., Wu, X. J., Wan, D. S., Lu, Z. H., Kong, L. H., Pan, Z. Z., & Chen, G. (2012). 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. Annals of Oncology : Official Journal of the European Society for Medical Oncology, 23(5), pp. 1348-53. doi:10.1093/annonc/mdr400.
Zhang RX, et al. 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. Ann Oncol. 2012;23(5):1348-53. PubMed PMID: 21940785.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Zhang,R X, AU - Wu,X J, AU - Wan,D S, AU - Lu,Z H, AU - Kong,L H, AU - Pan,Z Z, AU - Chen,G, Y1 - 2011/09/22/ PY - 2011/9/24/entrez PY - 2011/9/24/pubmed PY - 2012/9/8/medline SP - 1348 EP - 53 JF - Annals of oncology : official journal of the European Society for Medical Oncology JO - Ann. Oncol. VL - 23 IS - 5 N2 - 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. SN - 1569-8041 UR - https://www.unboundmedicine.com/medline/citation/21940785/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0923-7534(19)34683-6 DB - PRIME DP - Unbound Medicine ER -