Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.
Graduate School of Medical Science and Engineering, KAIST, Daejeon, South Korea.
BMC Cancer. 2017 Sep 2;17(1):615. doi: 10.1186/s12885-017-3624-7.
We aimed to explore the clinical benefit of adjuvant chemotherapy (AC) with fluoropyrimidine in patients with ypT0-3N0 rectal cancer after preoperative chemoradiation therapy (CRT) followed by total mesorectal excision (TME).
Patients with ypT0-3N0 rectal cancer after preoperative CRT and TME were included using prospectively collected tumor registry cohort between January 2001 and December 2013. Patients were categorized into two groups according to the receipt of AC. Disease-free survival (DFS) and overall survival (OS) were compared between the adjuvant and observation groups. To control for potential confounding factors, we also calculated propensity scores and performed propensity score-matched analysis for DFS and OS.
Of the 339 evaluated patients, 87 patients (25.7%) did not receive AC. There were no differences in DFS (hazard ratio [HR], 0.921; 95% confidence interval [CI], 0.562-1.507; P = 0.742) and OS (HR, 0.835; 95% CI, 0.423-1.648; P = 0.603) between the adjuvant and observation groups. After propensity score matching, DFS (HR, 1.129; 95% CI, 0.626-2.035; P = 0.688) and OS (HR, 1.200; 95% CI, 0.539-2.669; P = 0.655) did not differ between the adjuvant and observation groups. Advanced T stage and positive resection margin were independently associated with inferior DFS and OS on multivariate analysis.
AC did not improve DFS and OS for patients with ypT0-3N0 rectal cancer after preoperative CRT followed by TME in this cohort study. The confirmative role of AC in locally advanced rectal cancer should be evaluated in prospective randomized trials with a larger sample size.
我们旨在探讨氟嘧啶辅助化疗（AC）在接受术前放化疗（CRT）后完全直肠系膜切除（TME）的 ypT0-3N0 直肠癌患者中的临床获益。
使用 2001 年 1 月至 2013 年 12 月期间前瞻性收集的肿瘤登记队列，纳入接受术前 CRT 和 TME 治疗的 ypT0-3N0 直肠癌患者。根据是否接受 AC 将患者分为两组。比较辅助组和观察组之间的无病生存（DFS）和总生存（OS）。为了控制潜在的混杂因素，我们还计算了倾向评分，并对 DFS 和 OS 进行了倾向评分匹配分析。
在 339 例评估的患者中，87 例（25.7%）未接受 AC。DFS（风险比[HR]，0.921；95%置信区间[CI]，0.562-1.507；P=0.742）和 OS（HR，0.835；95%CI，0.423-1.648；P=0.603）在辅助组和观察组之间无差异。在进行倾向评分匹配后，DFS（HR，1.129；95%CI，0.626-2.035；P=0.688）和 OS（HR，1.200；95%CI，0.539-2.669；P=0.655）在辅助组和观察组之间无差异。多变量分析显示，T 分期较晚和阳性切缘与DFS 和 OS 较差独立相关。
在本队列研究中，接受术前 CRT 后完全直肠系膜切除的 ypT0-3N0 直肠癌患者中，AC 并未改善 DFS 和 OS。在具有更大样本量的前瞻性随机试验中，应评估 AC 在局部晚期直肠癌中的确认作用。
