Wait-and-see or radical surgery for rectal cancer patients with a clinical complete response after neoadjuvant chemoradiotherapy: a cohort study

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.

Wait-and-see treatment strategies for rectal cancer patients with clinical complete response after neoadjuvant chemoradiotherapy: a systematic review and meta-analysis

“…The male/female ratio was 144/107 and 196/132 in the two groups, respectively. Observation group patients seemed to be older than those in the radical surgery group [2, 4, 7–9, 13]. Except for one observation group patient with liver metastasis in Smith et al [8], no patients had distant metastasis (DM) according to the study descriptions.…”

“…Several papers by Habr-Gama and colleagues describing studies of Brazilian patients were examined [4, 14, 15, 18, 20, 22, 23, 26], but only one of them that included all data of interest was recruited for this meta-analysis [4]. Finally, nine comparative studies of 26 trials which focused on oncologic outcome in patients with cCR in a wait-and-see group compared to those with pCR in a radical surgery group were identified [2, 4–9, 11, 13] (Table 2). Tables 2 and 3 show the main characteristics of these nine comparative studies.…”

“…Several studies have demonstrated superior local control with this strategy, which even leads to a clinical complete response (cCR), defined as the absence of detectable residual tumor cells, in a substantial proportion of patients treated by NCRT. Nevertheless, a wait-and-see policy might be more beneficial for rectal cancer patients with no residual tumor or involved lymph nodes after NCRT [2, 3]. The first study of the wait-and-see policy, which entails observational management of rectal cancer patients with a cCR after NCRT, was reported by Habr-Gama et al [4].…”

“…A series of retrospective studies from the same group [3] showed that patients with a cCR who were managed with an observational approach had survival rates similar to patients with a pathologic clinical response (pCR) who underwent radical surgery. Although this was a small study, the wait-and-see policy attracted much interest among clinicians, and additional studies [2, 5–11] have confirmed the efficacy of an observational approach using MRI and endoscopy with biopsy to evaluate clinical responses.…”

Waiting Time following Neoadjuvant Chemoradiotherapy for Rectal Cancer: Does It Really Matter

“…Although no statistically significant predictors of either complete response or tumor nodal status downstaging were identified, a trend towards pCR was seen within the group that waited longer to have surgery following completion of long-course CRT. In another cohort study, Li et al [23] compared the oncological outcomes of rectal cancer patients with clinical complete response who were managed according to a wait-and-see policy or with surgery. They postulated that under strict criteria a wait-and-see policy might be considered instead of surgery for rectal cancer patients with no residual tumor or involved lymph nodes after neoadjuvant CRT.…”