Sasaki Takeshi, Ito Yoshinori, Ohue Masayuki, Kanemitsu Yukihide, Kobatake Takaya, Ito Masaaki, Moriya Yoshihiro, Saito Norio
1 Division of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan 2 Department of Therapeutic Radiology, National Cancer Center Hospital, Tokyo, Japan 3 Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan 4 Division of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan 5 Department of Gastroenterological Surgery, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Dis Colon Rectum. 2017 Sep;60(9):914-921. doi: 10.1097/DCR.0000000000000870.
After treatment with local excision for TNM stage I low rectal cancer, the risk of local recurrence is not only high for T2 lesions but also for T1 lesions with features of massive invasion to the submucosal layer and/or lymphovascular invasion.
The purpose of this study was to determine the efficacy of chemoradiotherapy combined with local excision in the treatment of T1 to T2 low rectal cancer.
We conducted a prospective, single-arm, phase II trial.
This was a multicenter study.
From April 2003 to October 2010, 57 patients were treated with local excision after additional external beam irradiation (45 Gy) plus continuous 5-week intravenous injection of 5-fluorouracil (250 mg/m per day) at 10 domestic hospitals. Fifty-three patients had clinical T1N0 lesions, and 4 had T2N0 lesions in the low rectum, located below the peritoneal reflection.
The primary end point was disease-free survival at 5 years.
The completion rate for full-dose chemoradiotherapy was 86% (49/57). Serious, nontransient treatment-related complications were not reported. With a median follow-up of 7.3 years after local excision, the 5-year disease-free survival rate was 94% for the 53 patients with T1 lesions and 75% for the 4 patients with T2 lesions. There were 2 local recurrences during the entire observation period. Anal function after local excision and chemoradiation were kept at almost the same levels as observed before treatment.
The study was limited by the small number of registered T2 rectal cancers, retrospective evaluations of quality of life, and the exclusion of poorly differentiated adenocarcinoma (a high-risk feature of T1 lesions).
The addition of chemoradiotherapy to local excision of T1 rectal adenocarcinomas with poor prognostic features including deep submucosal invasion and lymphovascular invasion could improve on less favorable historic oncologic outcomes of local excision alone in this high-risk group for lymph node metastasis. See Video Abstract at http://links.lww.com/DCR/A421.
对于TNM I期低位直肠癌患者，采用局部切除术后，不仅T2期病变局部复发风险高，而且具有黏膜下层大量浸润和/或淋巴管浸润特征的T1期病变局部复发风险也高。
本研究旨在确定放化疗联合局部切除治疗T1至T2期低位直肠癌的疗效。
我们开展了一项前瞻性单臂II期试验。
这是一项多中心研究。
2003年4月至2010年10月，国内10家医院的57例患者在接受额外的外照射（45 Gy）加连续5周静脉注射5-氟尿嘧啶（每天250 mg/m）后接受局部切除治疗。53例患者为临床T1N0病变，4例患者为低位直肠T2N0病变，位于腹膜反折以下。
主要终点是5年无病生存率。
全剂量放化疗的完成率为86%（49/57）。未报告严重的、非短暂性的治疗相关并发症。局部切除术后中位随访7.3年，53例T1期病变患者的5年无病生存率为94%，4例T2期病变患者的5年无病生存率为75%。在整个观察期内有2例局部复发。局部切除和放化疗后的肛门功能维持在与治疗前观察到的水平几乎相同。
本研究受限于登记的T2期直肠癌病例数少、生活质量的回顾性评估以及排除低分化腺癌（T1期病变的高危特征）。
对于具有包括深层黏膜下浸润和淋巴管浸润等不良预后特征的T1期直肠腺癌，在局部切除的基础上加用放化疗，可改善该淋巴结转移高危组单纯局部切除时较差的历史肿瘤学结局。见视频摘要：http://links.lww.com/DCR/A421 。
