术前放化疗后直肠癌局部切除术：多中心 II 期临床试验结果。

Local excision after preoperative chemoradiotherapy for rectal cancer: results of a multicenter phase II clinical trial.

机构信息

1Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy 2Department of Radiation Oncology, National Cancer Institute, Aviano, Italy 3General Surgery, University Politecnica delle Marche, Ancona, Italy 4Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy 5Department of Surgical Oncology, National Cancer Institute, Aviano, Italy 6Department of Radiotherapy, State Hospital, Ancona, Italy 7Department of Radiotherapy, Catholic University of Rome, Rome, Italy 8Department of Pathology, National Cancer Institute, Aviano, Italy 9Department of Surgical Sciences, Catholic University of Rome, Rome, Italy.

出版信息

Dis Colon Rectum. 2013 Dec;56(12):1349-56. doi: 10.1097/DCR.0b013e3182a2303e.

DOI:10.1097/DCR.0b013e3182a2303e

PMID:24201388

Abstract

BACKGROUND

Transanal local excision has been suggested as an attractive approach for patients with rectal cancer who show a major clinical response after preoperative chemoradiotherapy.

OBJECTIVE

To evaluate the impact of transanal local excision on the local recurrence of rectal cancer in patients who had a major clinical response after preoperative chemoradiotherapy.

DESIGN

Sequential 2-stage phase II study for early efficacy.

SETTING

Multicenter study.

PATIENTS

Patients with clinical T3 or low-lying T2 rectal adenocarcinoma that showed a major clinical response after a preoperative chemoradiotherapy. Eligible patients underwent a full-thickness transanal local excision. According to their histopathology, the patients staged as ypT0-1 were observed, while the remaining patients were recommended to undergo a subsequent total mesorectal excision.

MAIN OUTCOME MEASURES

A local recurrence rate of ≤5% was set as a successful rate for stopping the trial early after the first stage.

RESULTS

The study group included 63 patients. Before chemoradiotherapy, patients were staged as clinical T3 (n = 42) and T2 (n = 21). After the local excision, 43 patients fulfilled the criteria to be observed with no further treatment. Nine of the remaining 20 patients for whom a subsequent total mesorectal excision was recommended refused surgery. Two of these patients who refused surgery had intraluminal local recurrence; both had a ypT2 tumor and underwent salvage surgery. The estimated cumulative 3-year overall survival, disease-free survival and local disease-free survival were 91.5% (95% CI: 75.9-97.2), 91.0% (95% CI: 77.0-96.6) and 96.9% (95% CI: 80.3-99.5), respectively.

LIMITATIONS

The time of follow-up is still short and the sample size is limited.

CONCLUSIONS

Our data suggest that local excision is a good option for patients with a major clinical response after chemoradiotherapy. A longer period of follow-up is required to confirm these findings.

摘要

背景

经术前放化疗后出现主要临床缓解的直肠癌患者，经肛门局部切除术被认为是一种有吸引力的治疗方法。

目的

评估经肛门局部切除对术前放化疗后出现主要临床缓解的直肠癌患者局部复发的影响。

设计

早期疗效的连续两阶段二期研究。

设置

多中心研究。

患者

经术前放化疗后出现主要临床缓解的临床 T3 或低位 T2 直肠腺癌患者。符合条件的患者接受全层经肛门局部切除术。根据其组织病理学分期，ypT0-1 的患者接受观察，而其余患者被推荐接受后续全直肠系膜切除术。

主要观察指标

第一阶段后早期停止试验的成功率设定为局部复发率≤5%。

结果

研究组纳入 63 例患者。放化疗前，患者分期为临床 T3（n=42）和 T2（n=21）。局部切除后，43 例患者符合观察条件，无需进一步治疗。20 例建议行后续全直肠系膜切除术的患者中，有 9 例拒绝手术。这 20 例患者中有 2 例拒绝手术的患者发生腔内局部复发；这 2 例患者均为 ypT2 肿瘤，行挽救性手术。估计 3 年总生存率、无病生存率和局部无病生存率分别为 91.5%（95%CI：75.9-97.2）、91.0%（95%CI：77.0-96.6）和 96.9%（95%CI：80.3-99.5）。