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RECTAL SPARING APPROACH AFTER PREOPERATIVE RADIO - AND/OR CHEMO-THERAPY (RESARCH TRIAL): LONG-TERM ANALYSIS OF A PROSPECTIVE, MULTICENTER, OBSERVATIONAL STUDY

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Introduction

Watch and wait (WW) and Local Excision (LE) are rectal sparing approaches proposed to rectal cancer patients who achieved a complete (cCR) or major (mCR) response following neoadjuvant therapy, even if no prospective study reported long-term outcomes of both approaches. The aim of this study was to investigate the long-term outcomes of patients treated with both rectal-sparing approaches.

Aims & Methods

This is a long-term analysis of a prospective, multicenter, observational study that investigated the outcomes of patients with clinical stage II-III mid-low rectal adenocarcinoma treated with any neoadjuvant therapy, and either transanal LE and WW based on tumor response (cCR or mCR). The primary endpoints of this analysis are 5-year TME-, overall (OS), disease- (DFS), local (LRFS) and distant recurrence-free survival (DRFS).

Results

Out of 253 patients enrolled in 16 centers, 149 (58.9%) were managed with LE and 104 (41.1%) with WW. Most of the patients underwent long-course chemoradiotherapy (n=212, 83.6%), and 160 (63.2%) patients experienced a cCR, whereas 93 (36.8%) a mCR. Following LE, 40(15.8%) patients had high-risk features at histopathological analysis, and 19 underwent completion TME. At a median (IQR) follow-up of 43.0 (33.0-60.0) months, TME was performed in 47 (18.6%) patients, and the rectum was preserved in 206 (81.4%) patients. The estimated 5-year TME-, OS, DFS, LRFS, and DRFS was 80.7% (95%CI 77.2-86.3), 79.6% (95%CI 79.8-88.5), 92.0%(95%CI 91.7-97.0), 93.0%(95%CI 90.9-96.1), 92.5% (95%CI 91.0-96.3), respectively. In the WW group, 29(11.5%) had a tumor local regrowth, and the 5-year regrowth-free survival was 70.6% (95%CI 62.7-80.2).