| Purpose: In recent years,total neoadjuvant therapy(TNT)has emerged as a new therapeutic strategy against locally advanced rectal cancer(LARC).After administration of TNT,however,some patients show complete clinical response(cCR)to treatment,disputes about the effects of TNT,as well as clinical feasibility of watch and wait(W&W),and the alternative patients of W&W still exist.Therefore,this study aims to explore the effects of TNT,the clinical feasibility and safety of W&W,alternative patients of W&W and the best treatment after local recurrence of cCR patients during the W&W period.Methods: A total of 96 patients were included in this paper.cCR and non-cCR were observed when these patients were administered with TNT at the First Affiliated Hospital of Dalian Medical University,China from May 2015 to June 2021.These patients received different chemotherapeutic regimens,with close monitoring and W&W strategy being applied by a multidisciplinary team(MDT).According to treatment results,patients were divided into a cCR group and a non-cCR group;according to the recurrence during W&W,they were divided into a recurrence group and a no-local recurrence group.This study analyzed the factors that may affect the prognosis,and summarized the surgery and treatment after recurrence.Results: There were 66 males and 30 females.There were 51 patients with age ≤ 65 years old and 44 patients with age > 65 years old.After TNT treatment,25 patients had clinical complete remission(cCR),58 patients had clinical partial remission(PR),12 patients had disease stability(SD),and 1 patient had disease progression(PD).Follow-up to May 31,2022,one non-cCR patient without surgery died,with a total survival rate(OS)of 98.96% and a tumor-specific mortality rate(CSS)of 98.96%.The operation rate of non-cCR patients was 84.51% while the total rectal preservation rate(TRPR)was 5.00%,and the sphincter preservation rate(SPR)was 64.62%.The local regression rate of tumor after surgery was 56.67% while the regression rate of metastatic lymph nodes was 66.67%,and the distant metastasis rate was 10.00%,including 4 cases of lung metastasis,1 case of pelvic metastasis,1 case of lymph node recurrence after local resection,and no local regeneration.The average survival time was 37.03(11-87)months while the 5-year absolute survival rate was 100%,and the5-year disease-free survival rate was 71.80%.Further analysis was made on 13 clinical factors affecting the acquisition of cCR after TNT treatment.Gender(male)was an independent risk factor affecting the acquisition of cCR after TNT treatment.All patients with cCR voluntarily chose W&W,with an average survival time of31.34(10～84)months,OS: 100.00%,CSS: 100.00%.During the follow-up period,6patients were suspected of local recurrence,with 4 patients being simple local recurrence,1 patient being simple new distant metastasis,1 patient being local recurrence and new distant metastasis at the same time.Except one patient with definite local recurrence who refused to operate,the remaining simple local recurrence patients received surgical treatment,TRPR: 33.33%,SPR: 66.67%.Postoperative pathological results showed 4 cases of local recurrence,5 cases of p CR.From the 1st to the 12 th month,there was 1 case of simple local regeneration,1 case of simple new bone metastasis,and 1 case of local regeneration combined with new liver metastasis;3 cases of simple local regeneration in the 12 th to 24 th months,In the 26 th month,there was one case of simple local regeneration.30.00% of cCR patients had local regeneration occurring within 12 months,83.33% within 24 months,and 100.00% within 36 months.The local recurrence rate was 24.00%,the 5-year absolute survival rate was 100%,and the 5-year disease-free survival rate was 92.00%.The 5-year absolute survival rate of cCR patients was the same as that of non-cCR patients undergoing surgery,while the5-year disease-free survival rate was higher than that of non-CR patients(92.00% vs71.80%),but the difference was not statistically significant(p = 0.994),and W&W did not increase the risk of new distant metastasis(p > 0.05).Further analysis was made on the applicable patients of W&W according to the local recurrence situation during the W&W period.It was found that positive peripheral incisal margin(CRM)was an independent risk factor for the local recurrence of W&W(p < 0.05).Even if patients with positive CRM obtained cCR after TNT treatment,surgery should be received as soon as possible.Conclusion:1.TNT is an effective treatment for locally advanced middle and low rectal cancer.The total fall rate of this group of patients is 86.46%,with 25 patients(26.04%)getting cCR,and male patients are more likely to get cCR after TNT treatment;2.It is safe and feasible for cCR patients to choose W&W,and compared with surgery,W&W will not affect the 5-year absolute survival rate and 5-year disease-free survival rate of patients;3.CRM is an independent risk factor that affects the local recurrence of cCR patients during W&W.Even if patients with positive CRM obtained cCR after TNT treatment,surgery should be received as soon as possible. |
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