Background: The short-term outcomes of chemoradiotherapy (CRT) with S-1 (a combination of tegafur, gimeracil, and oteracil) following limited surgery for patients with T1 or T2 lower rectal cancer have shown encouraging results. Objectives: This study was designed to delve deeper into the long-term outcomes of CRT with S-1 after limited surgery, with the goal of evaluating both the long-term efficacy and potential risks associated with this treatment approach in patients diagnosed with T1 or T2 lower rectal cancer. Methods: This was conducted as a multicenter, single-arm, prospective phase II trial. The patient population consisted of individuals clinically diagnosed with either T1 or T2 lower rectal or anal canal cancer, with a maximum tumor diameter of 30 mm and classified as N0 or M0. Patients underwent local excision or endoscopic resection. After surgery, CRT with S-1 was administered to patients meeting several criteria, including the confirmation of well-differentiated or moderately differentiated adenocarcinoma, negative surgical margins, submucosal invasion depth of ≥1000 µm, and high tumor-budding grade (2/3). The primary endpoint of this study was relapse-free survival, while secondary endpoints included local recurrence-free survival, overall survival, anal sphincter preservation rate, and safety. Results: A total of 52 patients were included, with pathological diagnoses revealing T1 in 36 patients and T2 in 16 patients. The 3-year and 5-year relapse-free survival rates were 90.17% and 85.87%, respectively. The 3-year and 5-year local recurrence-free survival rates were 90.17% and 88.07%, respectively, while the 3-year and 5-year overall survival rates were 94.03% and 91.94%, respectively. Conclusions: CRT with S-1 after limited surgery for T1 lower rectal cancer demonstrated favorable outcomes in terms of recurrence, survival, and local control rates while effectively maintaining anal function in patients. However, further treatment approaches may be necessary to improve outcomes for patients diagnosed with stage T2 lower rectal cancer
背景：对于T1或T2期低位直肠癌患者，在局限性手术后接受S-1（替加氟、吉美嘧啶和奥替拉西的复方制剂）联合放化疗（CRT）的短期疗效已显示出令人鼓舞的结果。目的：本研究旨在深入探讨局限性手术后S-1联合CRT的长期疗效，以评估该治疗方案对T1或T2期低位直肠癌患者的长期疗效及潜在风险。方法：本研究为一项多中心、单臂、前瞻性II期临床试验。研究对象为临床诊断为T1或T2期低位直肠或肛管癌的患者，肿瘤最大直径不超过30毫米，且分期为N0或M0。患者接受了局部切除或内镜下切除术。术后，对符合以下多项标准的患者给予S-1联合CRT治疗：经病理证实为高分化或中分化腺癌、手术切缘阴性、黏膜下浸润深度≥1000微米、肿瘤出芽分级高（2/3级）。本研究的主要终点是无复发生存期，次要终点包括局部无复发生存期、总生存期、肛门括约肌保留率及安全性。结果：共纳入52例患者，病理诊断显示T1期36例，T2期16例。3年和5年无复发生存率分别为90.17%和85.87%。3年和5年局部无复发生存率分别为90.17%和88.07%，而3年和5年总生存率分别为94.03%和91.94%。结论：对于T1期低位直肠癌患者，局限性手术后接受S-1联合CRT治疗在复发率、生存率和局部控制率方面均表现出良好疗效，同时有效保留了患者的肛门功能。然而，对于诊断为T2期低位直肠癌的患者，可能需要进一步的治疗方案以改善其预后。
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