Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251).
Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251).
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DOI：
10.1002/cncr.26374
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发表时间：
2012-04-15
期刊：
影响因子：
6.2
通讯作者：
Pittelkow MR
中科院分区：
文献类型：
--
作者：
Kadakia KC;Barton DL;Loprinzi CL;Sloan JA;Otley CC;Diekmann BB;Novotny PJ;Alberts SR;Limburg PJ;Pittelkow MR
系统性类维生素a的化学预防在降低免疫功能低下的移植后受者新发原发性非黑色素瘤皮肤癌（NMSCs）的发生率方面已被证明是有希望的。在非移植患者中使用系统性维甲酸的证据有限。据作者所知，这是第一个随机对照试验，以评估阿维甲素作为化学预防剂对NMSC高风险非移植患者的疗效。本研究为前瞻性、随机、双盲、安慰剂对照临床试验。为了测试阿维a 2年治疗可能的皮肤癌预防效果，70名年龄≥18岁且在试验开始的5年内有≥2个NMSCs病史的非移植患者随机接受安慰剂或阿维a 25 mg口服，每周5天。主要结局指标为NMSC新发率。70例患者随机接受单独阿维a （N = 35）或安慰剂（N = 35）治疗。在2年的治疗期间，接受阿维素治疗的患者新生原发NMSCs的发生率没有统计学上的显著降低（优势比0.41；95%可信区间0.15-1.13;54% vs 74%; P = 0.13）。然而，利用新发NMSC的发生率、新发NMSC的时间和总NMSC计数，一项伞式检验显示，阿维a的使用有显著的趋势（卡方统计量为3.94;P = 0.047）。与接受安慰剂的患者相比，接受阿维a的患者报告了明显更多的粘膜炎和皮肤毒性。虽然在统计学上没有观察到使用阿维a的显著益处，但这可能是低统计学效力的结果。
Chemoprevention with systemic retinoids has demonstrated promise in decreasing the incidence of new primary nonmelanoma skin cancers (NMSCs) in immunocompromised post-transplantation recipients. There is limited evidence for the use of systemic retinoids in the nontransplantation patient. To the authors’ knowledge, this is the first randomized controlled trial to assess the efficacy of acitretin as a chemopreventive agent in nontransplantation patients at high risk for NMSC. The study was designed as a prospective, randomized, double-blind, placebo-controlled clinical trial. To test the possible skin cancer-preventing effect of a 2-year treatment with acitretin, 70 nontransplantation patients aged ≥18 years who had a history of ≥2 NMSCs within 5 years of trial onset were randomized to receive either placebo or acitretin 25 mg orally 5 days per week. The primary outcome measure was the rate of new NMSC development. Seventy patients were randomized to receive either acitretin alone (N = 35) or placebo (N = 35). During the 2-year treatment period, the patients who received acitretin did not have a statistically significant reduction in the rate of new primary NMSCs (odds ratio, 0.41; 95% confidence interval, 0.15–1.13; 54% vs 74%; P = .13). However, using the incidence of new NMSC, the time to new NMSC, and total NMSC counts, an umbrella test indicated a significant trend that favored the use of acitretin (chi-square statistic, 3.94; P = .047). The patients who received acitretin reported significantly more mucositis and skin toxicities compared with the patients who received placebo. Although there was not a statistically significant benefit observed with the use of acitretin, this may have been the result of low statistical power.
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DOI：
10.1007/978-0-387-77574-6_8
发表时间：
2008-01-01
期刊：
SUNLIGHT, VITAMIN D AND SKIN CANCER
影响因子：
--
作者：
Leiter, Ulrike;Garbe, Claus
通讯作者：
Garbe, Claus
影响因子：
1.9
作者：
OBRIEN, PC
通讯作者：
OBRIEN, PC
影响因子：
45.3
作者：
LEE, JS;LIPPMAN, SM;HANG, WK
通讯作者：
HANG, WK
影响因子：
2.4
作者：
De Graaf, YGL;Euvrard, S;Bavinck, JNB
通讯作者：
Bavinck, JNB
DOI：
10.1016/s0926-9959(97)00146-3
发表时间：
1998-01-01
影响因子：
9.2
作者：
Gibson, GE;O'Grady, A;Murphy, GM
通讯作者：
Murphy, GM