Abstract

A wait-and-see policy might be considered instead of surgery for rectal cancer patients with no residual tumor or involved lymph nodes on imaging or endoscopy after neoadjuvant chemoradiotherapy (clinical complete response, cCR). In this cohort study, we compared the oncologic outcomes of rectal cancer patients with a cCR who were managed according to a wait-and-see policy (observation group) or with surgery (surgery group). In the observation group, follow-up was performed every 3 months for the first year and consisted of MRI, endoscopy with biopsy, computed tomography and transrectal ultrasonography. In the surgery group, patients received radical surgery. Long-term oncologic outcomes were estimated using Kaplan-Meier curves. Thirty patients were enrolled in the observation group (median follow-up, 60 months; range, 18-100 months), and 92 patients were enrolled in the surgery group (median follow-up, 58 months; range, 18-109 months). The 5-year disease free survival and overall survival rates were similar in the two groups: 90.0% vs. 94.3% (P = 0.932) and 100.0% vs. 95.6% (P = 0.912), respectively. We conclude that for rectal cancer patients with a cCR after neoadjuvant chemoradiotherapy, a wait-and-see policy with strict selection criteria, follow-up and salvage treatments achieves outcomes at least as good as radical surgery. Additionally, we declare that the pCR (pathologic complete regression) and non-pCR subgroups of patients with a cCR have similar long-term failure (local recurrence and/or distant metastasis) rate.

Highlights

  • In cases of locally advanced rectal cancer, neoadjuvant chemoradiotherapy (NCRT) can induce tumor regression [1] and reduce local recurrence [2]

  • The observation group consisted of 30 patients with advanced rectal cancer who had a clinical complete response (cCR) after completing NCRT and were treated with nonoperation management

  • The wait-and-see policy for rectal cancer patients with a cCR after NCRT is based on careful selection and follow-up using endoscopy and up-to-date imaging, and appears both feasible and safe

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Summary

Introduction

In cases of locally advanced rectal cancer, neoadjuvant chemoradiotherapy (NCRT) can induce tumor regression [1] and reduce local recurrence [2] Following this treatment, evidence from digital rectal examination, magnetic resonance imaging (MRI), endoscopy with biopsy and transrectal ultrasonography indicates a clinical complete response (cCR) is attained in about 26.8% of patients [2, 3, 4]. HabrGama et al [6] reported that among 71 patients receiving nonoperative management, the 5-year overall survival (OS) and disease-free survival (DFS) rates were 100% and 92%, respectively, and the local recurrence (LR) rate was 3% This was a small study, the wait-andsee policy attracted much interest among clinicians, and Mass et al [7] confirmed the efficacy of a nonoperative approach using MRI and endoscopy with biopsy to evaluate clinical responses. The purpose of our study was to evaluate and compare the oncologic outcomes of rectal cancer patients who, after treatment with NCRT, achieved a cCR and were managed according to a wait-and-see policy or treated surgically

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