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Objective:To compare the outcomes of watch&wait (W&W) strategy in patients with locally advanced rectal cancer who achieved complete clinical response (cCR) after neoadjuvant therapy, with those who obtained pathological complete response (pCR) after total mesorectal excision (TME).Methods:This is a retrospective cohort analysis study. Patients histologically proven with locally advanced rectal adenocarcinoma (stage Ⅱ-Ⅲ) who had received neoadjuvant chemotherapy were eligible between January 2014 and December 2019. In whom we included patients who had cCR offered management with W&W strategy after completing neoadjuvant therapy and follow-up ≥1 year (W&W group), and patients who did not have cCR but pCR after TME (pCR group). The primary endpoints were 3-year and 5-year overall survival (OS), colostomy-free survival (CFS), disease-free survival (DFS), non-local regrowth disease-free survival (NR-DFS), and organ preservation rate. Kaplan-Meier analysis was used for survival analysis and log-rank test was performed. For comparative analysis, we also derived one-to-one paired cohorts of W&W versus pCR using propensity-score matching (PSM).Results:A total of 118 patients were enrolled, 49 of whom had cCR and managed by W&W, 69 had pCR, with a median follow-up period of 49.5 months (12.1-79.9 months). No difference was observed in the 3-year OS (97.1% vs. 96.7%) and 5-year OS (93.8% vs. 90.9%, P=0.696) between the W&W and pCR groups. Patients managed by W&W had significantly better 3-year and 5-year CFS (89.1% vs. 43.5%, P<0.001), better 3-year DFS (83.6% vs. 97.0%) and 5-year DFS (83.6% vs. 91.2%, P=0.047) compared with those achieving pCR. The 3-year NR-DFS (95.9% vs. 97.0%) and 5-year NR-DFS (92.8% vs. 97.0%, P=0.407) did not significantly differ between the W&W and pCR groups. Local regeneration occurred in six cases, and 87.7% of patients had successful rectum preservation in the W&W group. In the PSM analysis (34 patients in each group), absolutely better CFS (90.1% vs. 26.5%, P<0.001) was noted in the W&W group. A median interval of 17.5 weeks was observed for achieving cCR, while only 23.9% of patients achieved cCR within 5 to 12 weeks from radiation completion. Patients with short-course sequential chemoradiotherapy achieved cCR significantly later when compared with those with long-course concurrent chemoradiotherapy (19.0 vs. 9.8 weeks, P<0.001). Conclusions:The oncological outcomes of W&W strategy in patients with locally advanced rectal cancer are safe and effective, significantly improving the quality of life. Longer interval for cCR evaluation may improve rectal organ preservation rate.
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Objective:To analyze the correlation between the Naples prognostic score (NPS) after preoperative neoadjuvant chemoradiotherapy in locally advanced rectal cancer (LARC) and evaluate the prognostic value of NPS in LARC.Methods:136 patients with LARC meeting the recruitment criteria from 2015 to 2020 were selected. Serum albumin, total cholesterol (TC) were collected and neutrophil-lymphocyte ratio and lymphocyte-monocyte ratio were calculated. All patients were scored and graded according to the NPS rule. The survival rate was calculated with Kaplan- Meier method. Multivariate prognostic analysis was performed by Cox models. Results:There was no significant correlation between NPS score and tumor regression or pathological complete response (pCR) of LARC patients after neoadjuvant therapy ( P=0.192, P=0.163). However, Cox multivariate analysis showed that NPS was an independent risk factor for overall survival (OS) and disease-free survival (DFS) of LARC ( P=0.009, P=0.003), and hierarchical analysis suggested that LARC patients with lower NPS score obtained better prognosis. Besides NPS, tumor size was also an independent risk factor for OS, and tumor size and N stage were the independent risk factors for DFS. Conclusion:NPS has no correlation with tumor regression or pCR for LARC after neoadjuvant chemoradiotherapy, whereas it could serve as an effective predictor for long-term prognosis of LARC.