University of Wisconsin Carbone Cancer Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Eur J Cancer Prev. 2024 Jan 1;33(1):69-72. doi: 10.1097/CEJ.0000000000000829. Epub 2023 Jul 3.
Here we report clinical risk factors and event rates for the development of new non-melanoma skin cancer (NMSC) in a randomized, double-blind, placebo-controlled trial of the irreversible ornithine decarboxylase (ODC) inhibitor, difluromethylornithine (DFMO), over a 3-5-year follow-up.
147 placebo patients (white; mean age 60.2 years; 60% male) were evaluated for event rates and association of initial skin biomarkers and baseline patient characteristics with the development of squamous cell (SCC) and basal cell (BCC) carcinomas.
Post-study evaluation (median follow-up 4.4 years) indicates the measures of prior NMSCs ( P ≤ 0.001), prior BCCs ( P ≤ 0.001), prior SCCs ( P = 0.011), prior tumor rate ( P = 0.002), hemoglobin ( P = 0.022), and gender ( P = 0.045) as significant predictors for new NMSC development. Similarly, all measures of prior BCCs and NMSCs ( P < 0.001), prior tumor rate ( P = 0.014), and SCCs in the prior 2 years ( P = 0.047) were statistically significant predictors for new BCC development. Total prior NMSCs and those in the prior 5 years ( P < 0.001), total prior SCCs and those in the prior 5 years ( P < 0.001), total prior BCCs and those in the prior 5 years ( P ≤ 0.001), prior tumor rate ( P = 0.011) as well as age ( P = 0.008), hemoglobin ( P = 0.002), and gender ( P = 0.003) were statistically significant predictors of new SCC development. TPA-induced ODC activity at baseline showed no statistically significant association with the development of new NMSC ( P = 0.35), new BCCs ( P = 0.62), or new SCCs ( P = 0.25).
In the studied population, the history of and rate at which prior NMSCs occur are predictive and should be controlled for in future NMSC prevention trials.
我们报告了在一项为期 3-5 年的、针对不可逆鸟氨酸脱羧酶（ODC）抑制剂 difluromethylornithine（DFMO）的随机、双盲、安慰剂对照试验中，新非黑色素瘤皮肤癌（NMSC）发展的临床风险因素和事件发生率。
147 名安慰剂患者（白人；平均年龄 60.2 岁；60%为男性）评估了事件发生率，并评估了初始皮肤生物标志物和基线患者特征与鳞状细胞（SCC）和基底细胞（BCC）癌发展的关系。
研究后评估（中位随访 4.4 年）表明，先前 NMSC（P ≤ 0.001）、先前 BCC（P ≤ 0.001）、先前 SCC（P = 0.011）、先前肿瘤发生率（P = 0.002）、血红蛋白（P = 0.022）和性别（P = 0.045）是新 NMSC 发展的显著预测因素。同样，先前 BCC 和 NMSC 的所有指标（P < 0.001）、先前肿瘤发生率（P = 0.014）和前 2 年 SCC（P = 0.047）也是新 BCC 发展的统计学显著预测因素。先前总 NMSC 和前 5 年（P < 0.001）、先前总 SCC 和前 5 年（P < 0.001）、先前总 BCC 和前 5 年（P ≤ 0.001）、先前肿瘤发生率（P = 0.011）以及年龄（P = 0.008）、血红蛋白（P = 0.002）和性别（P = 0.003）是新 SCC 发展的统计学显著预测因素。基线 TPA 诱导的 ODC 活性与新 NMSC（P = 0.35）、新 BCC（P = 0.62）或新 SCC（P = 0.25）的发展无统计学显著相关性。
在研究人群中，先前 NMSC 的发生频率和发生率是可以预测的，在未来的 NMSC 预防试验中应该加以控制。
