Miyoshi Norikatsu, Uemura Mamoru, Noura Shingo, Yasui Masayoshi, Nishimura Junichi, Tei Mitsuyoshi, Matsuda Chu, Morita Shunji, Inoue Akira, Tamagawa Hiroki, Mokutani Yukako, Yoshioka Shinichi, Fujii Makoto, Kato Shinya, Sekido Yuki, Ogino Takayuki, Yamamoto Hirofumi, Murata Kohei, Doki Yuichiro, Eguchi Hidetoshi
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan.
Department of Innovative Oncology Research and Regenerative Medicine, Osaka International Cancer Institute, Osaka 541-8567, Japan.
Cancers (Basel). 2024 Sep 30;16(19):3360. doi: 10.3390/cancers16193360.
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.
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.
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.
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.
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.
对于T1或T2期低位直肠癌患者，在有限手术之后进行S-1（替加氟、吉美嘧啶和奥替拉西的组合）同步放化疗（CRT）的短期疗效已显示出令人鼓舞的结果。
本研究旨在更深入地探究有限手术之后S-1同步放化疗的长期疗效，目的是评估这种治疗方法对诊断为T1或T2期低位直肠癌患者的长期疗效及潜在风险。
本研究作为一项多中心、单臂、前瞻性II期试验开展。患者群体包括临床诊断为T1或T2期低位直肠癌或肛管癌、最大肿瘤直径为30mm且分类为N0或M0的个体。患者接受局部切除或内镜切除。手术后，对符合多项标准的患者给予S-1同步放化疗，这些标准包括确诊为高分化或中分化腺癌、手术切缘阴性、黏膜下浸润深度≥1000µm以及高肿瘤芽生分级（2/3）。本研究的主要终点是无复发生存期，次要终点包括无局部复发生存期、总生存期、肛门括约肌保留率和安全性。
共纳入52例患者，病理诊断显示36例为T1期，16例为T2期。3年和5年无复发生存率分别为90.17%和85.87%。3年和5年无局部复发生存率分别为90.17%和88.07%，而3年和5年总生存率分别为94.03%和91.94%。
对于T1期低位直肠癌患者，有限手术之后S-1同步放化疗在复发、生存和局部控制率方面显示出良好疗效，同时有效维持患者肛门功能。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法来改善疗效。
