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
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
复制标题
DOI：
10.1093/annonc/mdr400
复制
发表时间：
2012-05-01
影响因子：
50.5
通讯作者：
Chen, G.
中科院分区：
文献类型：
--
作者：
Zhang, R. X.;Wu, X. J.;Chen, G.
手足综合征（HFS）是卡培他滨最常见的不良反应。部分临床医生认为HFS是一种局限于手足的炎症，可以通过考克斯-2抑制剂（塞来昔布）来预防，我们设计了一项单中心、前瞻性随机临床试验来验证这一假设。2008年8月至2010年12月，接受卡培他滨为基础化疗的II期和III期结直肠癌患者自愿入组试验。所有患者随机分为塞来昔布组和非塞来昔布组。卡培他滨组1级和2级HFS发生率高于卡培他滨/塞来昔布组（74.6%vs57.4%，P = 0.034; 29.6%vs14.7%，P = 0.035）。塞来昔布（P < 0.001，P = 0.003）和二氢嘧啶脱氢酶（P = 0.048，P = 0.014）的使用影响1级和2级HFS的发生率，如对数秩分析所确定的。多因素考克斯比例风险回归分析显示，塞来昔布是影响≥ 1级HFS发生率的唯一因素[危险比（HR）：0.556，P = 0.001]和≥ 2级HFS发生率的唯一因素（HR：0.414，P = 0.005），塞来昔布可安全有效地预防卡培他滨相关HFS。
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).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.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).Celecoxib can be used effectively and safely to prevent capecitabine-related HFS.