| Objective:To analyze adverse events and efficacy of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy for patients with resectable cT3-4a/N+ thoracic esophageal squamous cell carcinoma,in order to provide reference for the best neoadjuvant treatment for patients with locally advanced resectable thoracic esophageal squamous cell carcinoma.Methods: The clinicopathological data of patients with cT3-4a/N+thoracic esophageal squamous cell carcinoma who were confirmed by pathology and underwent radical resection after nCRT or nCT in our hospital from January 1,2011 to December 31,2019 were analyzed retrospectively.The adverse events,recurrence and metastasis patterns and prognosis of nCRT and nCT were analyzed.Comparison between groups was made by χ~2 test or Fishers exact probability method.Kaplan-Meier method was used to calculate the estimated survival rate and draw the survival curve.Log-rank test was used to compare the difference of survival rate.P < 0.05 was taken as the significance test standard.Results:A total of 455 patients were included,including 329 males and 126 females,the ratio of male to female was 2.6: 1;There were 42cases(9.2%)in the upper thoracic segment,336 cases(73.9%)in the middle thoracic segment and 77 cases(16.9%)in the lower thoracic segment.There were 236 cases(51.9%)in stage Ⅱ,211 cases(46.4%)in stage Ⅲ and 8 cases(1.7%)in stage ⅣA;50 cases received nCRT and405 cases received nCT.In order to avoid the influence of unbalanced baseline data on the final result,two groups with balanced baseline data were matched among 455 patients in the whole group.These factors were included in the analysis as covariates,and a 1: 1 match was made between nCRT group and nCT group with a matching tolerance of 0.1.There are 92 patients in the whole group,46 in nCRT group and 46 in nCT group.1 adverse events of neoadjuvant therapy Myelosuppression is the most common adverse events of neoadjuvant therapy.The incidence of grade 1-2 myelosuppression was26.1%(24/92),among which nCRT group was 41.3%(19/46)and nCT group was 10.9%(5/46),and the difference between the two groups was statistically significant(χ~2=11.049,P=0.001).There was no significant difference in the incidence of grade ≥3 myelosuppression between the two groups.No pneumonia and gastrointestinal adverse events of grade≥3 occurred in all patients.2 Postoperative pathological features2.1 pCR rate The pCR rate of all patients was 15.2%(14/92),among which nCRT was 28.3%(13/46)and nCT group was 2.2%(1/46).The difference was statistically significant,suggesting that nCRT can significantly improve the pCR rate of esophageal squamous cell carcinoma patients(χ~2=12.132,P=0.000).2.2 resection rate of R0 The resection rate of R0 was 96.7%(89/92),including 100%(46/46)in nCRT and 93.5%(43/46)in nCT group.There was no significant difference between the two groups(χ~2=1.378,P=0.240).2.3 down-staging after operation Compared with preoperative staging and postoperative staging,54.3% of the patients had T down-staging after operation,and the proportion of T stage down-staging in nCRT group was 69.6%(32/46),which was significantly higher than 39.1%(18/46)in nCT group(χ~2=8.587,P=0.003).2.4 nerve invasion 9.8%(9/92)patients showed nerve invasion after operation,and the incidence of nerve invasion in nCRT group was 4.3%(2/46),while that in nCT group was 15.2%(7/46).There was no significant difference between the two groups(χ~2=1.971,P=0.160).2.5 vascular tumor thrombus 4.3%(4/92)patients showed vascular tumor thrombus after operation,among which nCRT group was 0.0%(0/46)and nCT group was8.7%(4/46),and there was no significant difference between the two groups(χ~2=2.352,P=0.125).2.6 lymph nodes after operation The rate of postoperative lymph node negative patients was47.8%(44/92),including 56.2%(26/46)in nCRT group and 39.1%(18/46)in nCT group.There was no significant difference between the two groups(χ~2=2.788,P=0.095).3 Complications and adjuvant therapy The incidence of postoperative pneumonia in the whole group was5.4%(5/92),which was 8.7%(4/46)in nCRT group and 2.2%(1/46)in nCT group.There was no significant difference between the two groups(χ~2=0.846,P=0.358).The incidence of anastomotic leakage was12.0%(11/92),which was 17.4%(8/46)in nCRT group and 6.5%(3/46)in nCT group.There was no significant difference between the two groups(χ~2=2.581,P=0.108).The incidence of gastrointestinal bleeding was2.2%(2/92),which was 4.3%(2/46)in nCRT group and 0%(0/46)in nCT group.There was no significant difference between the two groups(χ~2=0.511,P=0.475).The average postoperative hospital stay was 16days(10±28 days),among which nCRT group was 17.2±5.3 days and nCT group was 14.9±4.2 days,with no significant difference between the two groups(P=0.065). The proportion of patients receiving adjuvant therapy after operation was 40.2%(37/92),among which nCRT group was 28.3%(13/46)and nCT group was 52.2%(24/46),with significant difference between the two groups(χ~2=5.470,P=0.019).4 Postoperative recurrence and metastasis There was no anastomotic recurrence in nCRT group,and the anastomotic recurrence rate in nCT group was 2.2%(1/46).There was no significant difference between the two groups(χ~2=0.000,P=1.000).The local failure rate of nCRT group was 15.2%(7/46)in nCRT group and15.2%(7/46)in nCT group.There was no significant difference between the two groups(χ~2=0.000,P=1.000). The incidence of lymph node metastasis was 17.4%(8/46)in nCRT group and 10.9%(5/46)in nCT group,and there was no significant difference between the two groups(χ~2=0.806,P=0.369). The incidence of distant metastasis was 19.6%(9/46)in nCRT group and 21.7%(10/46)in nCT group.There was no significant difference between the two groups(χ~2=0.066,P=0.797).5 Disease-free survival analysis The mDFS in nCRT group was 26.3 months(95% CI: 11.5～41.2),and the 1-,3-,and 5-year disease-free survival rates were 65.1%,42.7%,and 42.7%,respectively.The mDFS in nCT group was 34.1 months(95%CI: 12.5～55.6),and the 1-,3-,and 5-year disease-free survival rates were63.0%,46.0% and 30.6%,respectively.There was no significant difference between the two groups(χ~2=0.029,P=0.864).6 Overall survival analysis The mOS in nCRT group was 45.8 months(95% CI: 21.3～70.3),and the overall survival rates in 1,3 and 5 years were75.8%,55.7% and39.8%,respectively.The mOS in nCT group was 43.9 months(95% CI:37.6～50.1),and the overall survival rates in 1,3 and 5 years were 80.4%,60.0%,and 40.2%,respectively.There was no significant difference between the two groups(χ~2=0.068,P=0.794).7 Subgroup analysis Patients in the two groups were divided according to the baseline data such as age(≤60 years old/>60 years old),BMI(<22.9/≥22.9),tumor location(upper/middle/lower thoracic segment),lesion length(≤ 5cm/>5 cm),cT3,c N(0/+),and the prognosis of OS was analyzed in each subgroup.The dominant population of neoadjuvant chemoradiotherapy was not screened out.Conclusion:1.Compared with nCT,nCRT can significantly improve the pCR rate of patients with resectable cT3-4a/N+ thoracic esophageal squamous cell carcinoma,and the safety is high2.The toxicity and side effects of nCRT are controllable as a whole,and strict hematological tests are still needed in clinical practice3.As this study is a retrospective study,it is necessary to further study the potential beneficiaries and indications of nCRT for locally advanced esophageal squamous cell carcinoma... |
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