中低位直肠癌术前同步放化疗与单纯手术治疗的比较：一项前瞻性随机试验的中期分析

Surgery with versus without preoperative concurrent chemoradiotherapy for mid/low rectal cancer: an interim analysis of a prospective, randomized trial.

作者信息

Fan Wen-Hua, Wang Fu-Long, Lu Zhen-Hai, Pan Zhi-Zhong, Li Li-Ren, Gao Yuan-Hong, Chen Gong, Wu Xiao-Jun, Ding Pei-Rong, Zeng Zhi-Fan, Wan De-Sen

机构信息

State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China.

Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China.

出版信息

Chin J Cancer. 2015 Jun 10;34(9):394-403. doi: 10.1186/s40880-015-0024-8.

DOI:10.1186/s40880-015-0024-8

PMID:26111932

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4593338/

Abstract

INTRODUCTION

Multimodality therapy, including preoperative chemoradiotherapy (CRT) and total mesorectal excision (TME), has effectively reduced local recurrence rates of rectal cancer over the past decade. However, the benefits and risks of the addition of neoadjuvant CRT to surgery need to be evaluated. This study was to compare the efficacy of TME with versus without preoperative concurrent chemoradiotherapy (CCRT) involving XELOX regimen (oxaliplatin plus capecitabine) in Chinese patients with stages II and III mid/low rectal adenocarcinoma.

METHODS

We randomly assigned patients to the TME group (TME without preoperative CCRT) or CCRT + TME group (TME with preoperative CCRT). The primary endpoint was disease-free survival (DFS); the secondary endpoints were overall survival (OS), local and distant recurrence, tumor response to CRT, toxicity, sphincter preservation, and surgical complications. An interim analysis of the potential inferiority of DFS in the CCRT + TME group was planned when the first 180 patients had been followed up for at least 6 months.

RESULTS

A total of 94 patients in the TME group and 90 patients in the CCRT + TME group were able to be evaluated. The 3-year DFS and OS rates were 86.3 % and 91.5 % in the whole cohort, respectively. The 3-year DFS rates of the TME and CCRT + TME groups were 85.7% and 87.9 % (P = 0.766), respectively, and the 3-year OS rates were 90.7 % and 92.3 % (P = 0.855), respectively. The functional sphincter preservation rates of the TME and CCRT + TME groups were 71.3 % and 70.0 % (P = 0.849), respectively. In the TME group, 16 (17.0 %) patients were proven to have pTNM stage I disease after surgery. In the CCRT + TME group, 32 (35.6 %) patients achieved a pathologic complete response (pCR).

CONCLUSIONS

Preliminary results indicated no significant differences in the DFS, OS, or functional sphincter preservation rates between the TME and CCRT + TME groups. However, preoperative CCRT with XELOX yielded a high pCR rate. Newer techniques are needed to improve the staging accuracy, and further investigation is warranted.

CLINICAL TRIAL REGISTRATION NUMBER

Chi CTR-TRC-08000122.

摘要

引言

多模式治疗，包括术前放化疗（CRT）和全直肠系膜切除术（TME），在过去十年中有效降低了直肠癌的局部复发率。然而，手术中增加新辅助CRT的益处和风险需要评估。本研究旨在比较TME联合与不联合术前同步放化疗（CCRT，采用XELOX方案，即奥沙利铂加卡培他滨）对中国II期和III期中低位直肠腺癌患者的疗效。

方法

我们将患者随机分为TME组（不进行术前CCRT的TME）或CCRT + TME组（进行术前CCRT的TME）。主要终点是无病生存期（DFS）；次要终点是总生存期（OS）、局部和远处复发、肿瘤对CRT的反应、毒性、括约肌保留情况及手术并发症。计划在前180例患者至少随访6个月时，对CCRT + TME组DFS可能存在的劣势进行中期分析。

结果

TME组共94例患者、CCRT + TME组共90例患者可进行评估。整个队列的3年DFS率和OS率分别为86.3%和91.5%。TME组和CCRT + TME组的3年DFS率分别为85.7%和87.9%（P = 0.766），3年OS率分别为90.7%和92.3%（P = 0.855）。TME组和CCRT + TME组的功能性括约肌保留率分别为71.3%和70.0%（P = 0.849）。在TME组，16例（17.0%）患者术后被证实为pTNM I期疾病。在CCRT + TME组，32例（35.6%）患者达到病理完全缓解（pCR）。