Chien Chun-Ru, Chen William Tzu-Liang, Wang Hwei-Min, Ke Tao-Wei, Chiang Hua-Che, Chang Sheng-Chi, Huang Yu-Chun, Lin Che-Hung, Huang Chun-Lin, Lin Ying-Chun, Chen Tsung-Wei, Li Chia-Chin, Chao K S Clifford
Department of Radiation Oncology, China Medical University Hospital, Taichung, Taiwan, R.O.C.
School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan, R.O.C.
Anticancer Res. 2016 Nov;36(11):6155-6160. doi: 10.21873/anticanres.11207.
BACKGROUND/AIM: Capecitabine is the current standard oral chemotherapy used in neoadjuvant concurrent chemoradiotherapy (NCCRT) for locally advanced rectal cancer (LARC) in North America. We compared the effectiveness of another oral chemotherapy agent, UFT (an oral combination of uracil and tegafur), to that of capecitabine.
We identified LARC patients diagnosed from 2007 to 2011 using a population-based registry in Taiwan (Health and Welfare Data Science Center, HWDC) and constructed a propensity score matched cohort to balance observable potential confounders. We compared the hazard ratio (HR) of death between the UFT and capecitabine groups. We performed supplementary analysis (SA) to evaluate the robustness of our finding regarding potential unobserved confounders (SA-1) and the robustness of the result in a subgroup when an additional potential confounder was taken into account (SA-2).
Our study population comprised of 200 patients balanced with respect to observed co-variables. UFT lowered the hazard of death significantly more than capecitabine (HR=0.58, 95% confidence interval (CI)=0.35-0.95, p=0.03). Our result was moderately sensitive in SA-1 but not significant in SA-2.
The effectiveness of UFT in NCCRT for LARC is probably non-inferior to that of capecitabine.
背景/目的：在北美，卡培他滨是目前用于局部晚期直肠癌（LARC）新辅助同步放化疗（NCCRT）的标准口服化疗药物。我们比较了另一种口服化疗药物优福定（尿嘧啶和替加氟的口服组合）与卡培他滨的疗效。
我们利用台湾基于人群的登记系统（卫生福利数据科学中心，HWDC）确定了2007年至2011年诊断的LARC患者，并构建了倾向评分匹配队列以平衡可观察到的潜在混杂因素。我们比较了优福定组和卡培他滨组之间的死亡风险比（HR）。我们进行了补充分析（SA），以评估我们关于潜在未观察到的混杂因素的发现的稳健性（SA-1），以及在考虑另一个潜在混杂因素时亚组结果的稳健性（SA-2）。
我们的研究人群包括200名在观察到的协变量方面达到平衡的患者。优福定降低死亡风险的效果显著优于卡培他滨（HR=0.58，95%置信区间（CI）=0.35-0.95，p=0.03）。我们的结果在SA-1中具有中等敏感性，但在SA-2中不显著。
优福定在LARC的NCCRT中的疗效可能不劣于卡培他滨。
