| BackgroundThe current standard of care for locally advanced rectal cancers is neoadjuvant chemoradiotherapy(n CRT)followed by total mesorectal excision(TME)and adjuvant chemotherapy.Although TME can improve survival prognosis of patients,but it has a certain degree of mortality rate,patients usually will experience urinary,sexual,bowel dysfunction and low anterior resection syndrome(LARS).All of these issues seriously influence patients’ quality of life.We can judge the extend of tumor regression through digital rectal examination,colonoscopy and radiological examination.Some patients can reach the status of clinical complete response(c CR),which means no evidence of tumor residues under clinical examinations.Implementation of rectum-preserving management for patients with good reponse without compromise of their survival outcomes will realize the ideal outcome.At present,organ-preserving management includes local excision(LE)and watch and wait(WW).Results of studies have suggested that the long-term oncological outcomes of LE or WW could be comparable to outcomes of radical resection.However,LE will contribute to issues like anal pain,wound dehiscence and the risk of recurrence of WW is high,recurrence could possibly increase the risk of distant metastasis.Generally,although organ-preserving management is a huge gospel for patients,but its efficacy and suitable crowds are still not clear.The issue is yet to be further explored.Purpose1.This study aims to explore oncological and functional outcomes of n CRT followed by LE for rectal cancer,and to explore the value and suitable crowds of LE.In addition,the study also aims to explore influencing factors for local recurrence of LE.2.This study aims to explore oncological and functional outcomes of n CRT followed by nonoperative WW for rectal cancer,and to explore the efficacy of WW for near-c CR patients through prolongation of waiting time.The study also aims to explore influencing factors for local recurrence of WW.MethodsPart Ⅰ.Clinical data of patients who were judged c CR or near-c CR after treatment of n CRT followed by LE or radical surgery in the department of colorectal surgery of Changhai hospital between 2010 and 2022 were collected to be analyzed retrospectively.The primary endpoints are cancer specific survival(CSS),disease free survival(DFS),local recurrence(LR)and distant metastasis rate(DM).Cox’proportional hazard regression model is used to explore possible factors which affect local recurrence of LE.Part Ⅱ.Clinical data of patients who were judged c CR or near-c CR after treatment of n CRT followed by WW in the department of colorectal surgery of Changhai hospital between 2010 and 2022 were collected to be analyzed retrospectively.Meanwhile clinical data of patients who were p CR in postoperative pathological examinations after treatment of n CRT followed by TME were also collected.The primary endpoints are cancer specific survival(CSS),non-regrowth disease free survival(NRDFS),local recurrence rate(LR)and distant metastasis rate(DM).LARS questionnaire is used to evaluate patients’ postoperative anal functions.Cox’ proportional hazard regression model is used to explore possible factors which affect local recurrence of WW.LARS questionnaire is used to evaluate patients’ postoperative anal functions and the Kaplan–Meier method is used for survival analysis for two parts of the study.Log-rank test is used for comparision between groups.Significance is defined as a two-sided P < 0.05.ResultsPartⅠ.A total of 61 patients who received LE were included in the study and compared with 119 patients who received radical resection.There were no differences in the demographic and clinical data such as age,sex,body mass index,tumor size before n CRT,tumor stage before n CRT,and carcinoembryonic antigen etc.There were significant differences in the clinical data such as tumor distance to anal verge before n CRT,radiation doses,n CRT regimen,numbers of neoajuvant chemotherapy.Generally,the two groups were balanced in the baseline characteristics.After a median time of 30 months of followup,2(3.3%)patients died,10(16.4%)patients had local recurrence or distant metastasis.After a median time of 54 months of follow-up,16(13.4%)patients died in the radical resection group,20(16.8%)had local recurrence or distant metastasis,which consisted 6(5%)local recurrence,17(14.3%)distant metastasis.A total of 8 patients successfully completed salvageable surgeries after LE,52 patients eventually preserved their organs and the organ preservation rate was 85.2%.3-year CSS was 97.5%and96.4%(P=0.378)for LE and radical resection group,respectively.3-year OS was 97.5%and95.5%(P=0.382),3-year DFS was 76.8%and 84.7%(P=0.559),3-year NRDFS was 86.2% and 84.7%(P=0.615),respectively.3-year local recurrence rate was 15.7%and4.2%(P=0.017),and 3-year distant metastasis rate was 9.6%and12.6%(P=0.327),respectively.40(80%)had no LARS,10(20%)had mild LARS in the LE group;21(34.4%)had no LARS,21(34.4%)had mild LARS,19(31.1%)had serious LARS in the radical resection group(P<0.001).Results of multivariate analysis only showed that pathological tumor regression grading(p TRG)≥2(P=0.017,hazard ratio=17.208,95%confidence interval=1.649-179.547)was an independent influencing factor for local recurrence of LE.Part Ⅱ.A total of 76 patients who received WW were included in the study and 106 patients who were judged p CR in the postoperative pathological examinations after radical resection were also included.WW group consisted of 44 c CR and 32 near-c CR patients.There were differences in the demographic and clinical data such as age,sex,tumor size and tumor distance to anal verge before n CRT,tumor stage before n CRT,and neoajuvant therapy regimen etc.After a median time of 37 months of follow-up,3(3.9%)patients died,16(21.1%)patients had local recurrence or distant metastasis,which consisted of 12(15.8%)local regrowth,4(5.3%)distant metastasis,no pelvic reccurence occurred,only1(1.3%)patient had local regrowth and liver metastasis simultaneously.For c CR and nearc CR group in the WW group,3y-CSS was both 100%(P=0.317),3y-LR was 15.7% and13.8%(P=0.749),and 3y-DM was 4.5% and 10.6%(P=0.452),respectively.After a median time of 55 months of follow-up,9(8.4%)patients died in the p CR group,and 10(9.3%)had local recurrence or distant metastasis.Generally,3y-CSS was 100% and 98.8% for WW and p CR group(P=0.707),3y-OS was 100% and 97.7%(P=0.770),3y-NRDFS was 92.7% and94.7%(P=0.874),3y-DFS was 80.9% and 93.7%(P<0.001),respectively.WW group had higher local recurrence rate and distant metastasis rate.3y-LR was 14.7% and1.2%(P<0.001)for WW and p CR group,respectively.And 3y-DM was 7.3% and 4.1% for two groups,respectively.12 patients received salvageable surgeries in the WW group successfully.71 patients preserved organs eventually,and the organ preservation rate was93.4%.61(91%)had no LARS,5(7.5%)had mild LARS,and 1(1.5%)had serious LARS in the WW group;26(43.3%)had no LARS,24(40%)had mild LARS,and 10(16.7%)had serious LARS in the p CR group(P<0.001).Results of multivariate analysis only showed that the elevation of mean corpuscular hemoglobin concentration counts(P=0.029,hazard ratio=1.068,95% confidence interval=1.007-1.134)was an independent influencing factor for local regrowth of WW.ConclusionsPart Ⅰ.1.c CR or near-c CR patients who response well to n CRT are suitable for LE treatment.For these patients,LE can realize comparable efficacy to TME,and patients can eventually realize the purpose of preserving their rectums.2.For c CR or near-c CR patients after n CRT,pathological tumor regression grading(p TRG)≥ 2 is possilbly an independent influencing factor for local recurrence of LE.Part Ⅱ.1.Patients who reach c CR after n CRT are suitable for WW to preserve their organs.WW has comparable efficacy to radical surgery,and it can realize the patients’ purposes of preserving rectums.For near-c CR patients,WW can also be implemented through continuous evaluations,and it is suggested that the prolongation of waiting time does not impact general survival outcomes.2.The elevation of mean corpuscular hemoglobin concentration counts is an independent influencing factor for local regrowth of WW. |
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