| BackgroundColorectal cancer is one of the most common malignant tumors in China,and the new cases and deaths are in the forefront each year.Compared with European and American countries,the incidence of rectal cancer is higher than that of colon cancer in China.It is more common in low-medium and young patients.Therefore,this group usually has a strong willingness to preserve the anus.Neoadjuvant chemoradiotherapy combined with total mesorectal resection is the standard treatment mode for locally advanced rectal cancer.Neoadjuvant chemoradiotherapy can shrink the local tumor and increase the chance of anus preservation rate.In recent years,for patients with clinical complete response after neoadjuvant therapy,whether surgery can be avoided and adopt non-operative waiting and observation strategy is getting more and more attention.ObjectiveThe aim of this study was to evaluate the oncological and survival outcomes and analyze the feasibility of a Wait and Watch policy in middle and low rectal cancer after a clinical complete response(cCR)following neoadjuvant chemoradiotherapy.Therefore,we can further explore the treatment strategy of rectal cancer in line with China’s national conditions.MethodsA total of 104 patients with locally advanced middle and low rectal cancer who were treated in the Affiliated Cancer Hospital of Zhengzhou University from June2013 to December 2015 were collected retrospectively.Among them,38 cases were treated with waiting observation strategy(waiting observation group),and 66 cases with radical resection of rectal cancer as control group(operation group).The safety and feasibility of wait & watch treatment strategy were evaluated by comparing the clinicopathological features,short-term clinical outcome,quality of life and long-term survival prognosis between the two groups.At the same time,we conducted univariate and multivariate survival analysis of DFS in 104 patients with neoadjuvant chemoradiotherapy to explore the influencing factors of long-term survival prognosis.Results(1)The median follow-up time of the whole cohort was period was 33.0(9.0-66.5)months.By the end of follow-up,the 3-and 5-year overall survival rates were98.8% and 93.1%;the 3-and 5-year disease free survival rates were 88.0% and86.3%;the 3-and 5-year local recurrence free survival rate were 92.2% and 92.2%;the 3-and 5-year distant metastasis free survival rates were 95.5% and 92.9%.(2)Comparison between waiting watch group and the operation group.The3-year overall survival rate in the waiting watch group and the operation group were96.6% and 100.0%(P>0.05),the 5-year overall survival rate in the waiting watch group and the operation group were 82.8% and 95.0%(P>0.05).The 3-year disease free survival rate in the waiting watch group and the operation group were 85.5% and94.5%,and the 5-year disease-free survival rate was 81.2% and 90.7%,there were no statistical difference between the groups(P>0.05).There were 5 cases of local regeneration in the waiting watch group.The local recurrence rate in the waiting watch group was significantly higher than that in the operation group,which were19.8% and 1.7% respectively(P<0.05).The success rate of remedial surgery in the waiting watch group acieved 100.0%.After adopt remedial measure,there was no significant difference in local recurrence free survival rate between the two groups(P>0.05).The 5-year distant metastasis rates in the waiting watch group and the operation group were 6.3% and 7.8%,whose difference was not significant(P>0.05).Further analysis showed that the distant metastasis rate of patients with local recurrence in the waiting watch group(50.0%)was significantly higher than that of patients without local recurrence(2.9%),whose difference was statistically significant(P<0.05).(3)The anal preservation rate of patients in the two groups was compared by stratification for patients with tumor distance less than 5cm from the anal margin and patients with tumor distance greater than or equal to 5cm.The results showed that the overall anal preservation rate of the patients with the lower edge of the tumor less than 5cm from the anal edge after remedial surgery was 90.9% with recurrence in the waiting observation group,which was significantly higher than that 44.0% in the surgery group(χ~2=11.468,P=0.001).The QOL score scale results showed that the quality of life in the waiting watch group was better than that of the operation group,with significantly statistical difference.(4)Patients in the watch and wait group are older than those in the surgery group,whose difference was statistically significant(P<0.05).When compare with the location of the tumor,the tumor in the watch and wait group was closer to the anal margin(P<0.05).(5)The results of univariate analysis of DFS and clinicopathological characteristics of patients with neoadjuvant chemoradiotherapy showed DFS and tumor size(P=0.018),tumor differentiation degree(P=0.015),c N stage(P=0.013),cTNM stage(P=0.023)have statistical significance.The results of multivariate analysis of DFS and clinicopathological characteristics of patients with neoadjuvant chemoradiotherapy showed that tumor size(HR=2543,95%CI: 1.048-6.172,P=0.039),c N stage(HR=2.459,95%CI: 1.063-5.686,P=0.035)were the independent factors affecting the prognosis of neoadjuvant chemoradiotherapy.Conclusions1.Patients with advanced rectal cancer who have achieved clinical complete remission after neoadjuvant chemoradiotherapy,adopt the waiting watch strategy are safe and feasible.The salvage rate of patients with local tumor regeneration is high.The waiting watch strategy has a similar oncological outcomes as the traditional strategy.However,there are differences in research results in many institutions,so we need to conduct longer follow-up,larger sample size and more standardized clinical trials to confirm its reliability in the future.2.Tumor size,c N stage are independent factors that affect the prognosis of patients with neoadjuvant chemoradiotherapy for rectal cancer. |
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