Total mesorectal excision with or without preoperative chemoradiotherapy for resectable mid/low rectal cancer: a long-term analysis of a prospective, single-center, randomized trial.

Abstract

BACKGROUND:

The preliminary results of our phase II randomized trial reported comparable functional sphincter preservation rates and short-term survival outcomes between patients undergoing total mesorectal excision (TME) with or without preoperative concurrent chemoradiotherapy (CCRT). We now report the long-term results after a median follow-up of 71 months.

METHODS:

Between March 23, 2008 and August 2, 2012, 192 patients with T3-T4 or node-positive, resectable, mid/low rectal adenocarcinoma were randomly assigned to receive TME with or without preoperative CCRT. The following endpoints were assessed: cumulative rates of local recurrence and distant metastasis, disease-free survival (DFS), and overall survival (OS).

RESULTS:

The data of 184 eligible patients were analyzed: 94 patients in the TME group and 90 patients in the CCRT + TME group. In the whole cohort, the 5-year DFS and OS rates were 84.8% and 85.1%, respectively. The 5-year DFS rates were 85.2% in the CCRT + TME group and 84.3% in the TME group (P = 0.969), and the 5-year OS rates were 83.5% in the CCRT + TME group and 86.5% in the TME group (P = 0.719). The 5-year cumulative rates of local recurrence were 6.3% and 5.0% (P = 0.681), and the 5-year cumulative rates of distant metastasis were 15.0% and 15.7% (P = 0.881) in the CCRT + TME and TME groups, respectively. No significant improvements in 5-year DFS and OS were observed with CCRT by subgroup analyses.

CONCLUSIONS:

Both treatment strategies yielded similar long-term outcomes. A selective policy towards preoperative CCRT is thus recommended for rectal cancer patients if high-quality TME surgery and enhanced chemotherapy can be performed. Trial registration ChiCTR-TRC-08000122. Registered 16 July 2008.

• Authors: Fulong Wang, Wenhua Fan, Jianhong Peng, Zhenhai Lu, Zhizhong Pan, Liren Li, Yuanhong Gao, Hui Li, Gong Chen, Xiaojun Wu, Peirong Ding, Zhifan Zeng, Desen Wan
• Journal: Cancer communications (London, England) (Cancer Commun (Lond)) Vol. 38 Issue 1 Pg. 73 (12 20 2018) ISSN: 2523-3548 [Electronic] United States
• PMID: 30572939 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Aged
• Chemoradiotherapy (methods)
• Disease-Free Survival
• Humans
• Middle Aged
• Preoperative Care (methods)
• Prospective Studies
• Rectal Neoplasms (drug therapy, pathology, radiotherapy, surgery)