Abstract：
BACKGROUND: Concurrent chemoradiotherapy (CCRT) is the standard treatment for locoregional anal squamous cell carcinoma (ASCC) in western countries. However, there have been few reports on the clinical outcomes of CCRT in Japan. This study aimed to evaluate the clinical outcomes of CCRT, prognostic factors, and the clinical impact of programmed cell death-ligand 1 (PD-L1) expression of ASCC in Japan.
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.
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.
摘要：
背景：同期放化疗（CCRT）是西方国家局部肛门鳞状细胞癌（ASCC）的标准治疗方法。然而,日本很少有关于CCRT临床结局的报道.本研究旨在评估CCRT的临床结果，预后因素，以及日本ASCC程序性细胞死亡配体1（PD-L1）表达的临床影响。
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。
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。
