METHODS: Patients with locoregional ASCC were enrolled between 2007 and 2017. All patients received CCRT consisting of ≥ 45 Gy of radiation, 5-fluorouracil, and mitomycin C. Disease-free survival (DFS), overall survival (OS), and adverse events (AEs) were estimated. Expression of p16 and PD-L1 were assessed by immunohistochemical staining (IHC).
RESULTS: This study included 36 patients, of whom 30 (83.3%) were female. Among the participants, 32 (88.9%) achieved complete clinical remission, while six (16.7%) experienced recurrence. The five-year DFS and five-year OS were 72.2% and 84.7%, respectively. Grades ≥ 3 serious AEs included neutropenia in 10 (27.7%) and perianal dermatitis in eight (22.2%). In a univariate analysis, male sex, lymph node metastasis, and large tumor size were significantly associated with worse outcome. In a multivariate analysis, tumor size was an independent factor associated with short DFS. Of the 30 patients whose biopsy specimens were available for IHC, 29 (96.7%) were positive for p16, and 13 (43.3%) were positive for PD-L1. However, PD-L1 expression did not show any clinical impact.
CONCLUSIONS: The comparative etiology, clinical outcomes, and prognostic factors of CCRT observed in Japanese patients with locoregional ASCC were consistent with western data.
方法:2007年至2017年纳入了局部ASCC患者。所有患者均接受了包括≥45Gy辐射的CCRT,5-氟尿嘧啶,和丝裂霉素C.无病生存率(DFS),总生存期(OS),并估计不良事件(AE)。通过免疫组织化学染色(IHC)评估p16和PD-L1的表达。
结果:本研究包括36名患者,其中30人(83.3%)为女性。在参与者中,32例(88.9%)达到临床完全缓解,6人(16.7%)复发。五年DFS和五年OS分别为72.2%和84.7%,分别。≥3级的严重AE包括10例(27.7%)的中性粒细胞减少症和8例(22.2%)的肛周皮炎。在单变量分析中,男性,淋巴结转移,和大肿瘤大小与不良预后显著相关。在多变量分析中,肿瘤大小是与短DFS相关的独立因素。在30例活检标本可用于IHC的患者中,29例(96.7%)p16阳性,13例(43.3%)PD-L1阳性。然而,PD-L1表达未显示任何临床影响。
结论:比较病因,临床结果,在日本局部ASCC患者中观察到的CCRT预后因素与西方数据一致。