| Objective:To evaluate the safety and efficacy of neoadjuvant immunotherapy in combination with chemotherapy in resectable locally advanced esophageal squamous cell carcinoma.Method:Electronic medical records of patients with resectable locally advanced esophageal squamous cell carcinoma who underwent preoperative neoadjuvant therapy at the Department of Thoracic Surgery,Second Hospital of Jilin University from September 2020 to December 2022 were collected and divided into two groups according to whether immunotherapy was used;patients in the combination group used programmed cell death receptor 1 inhibitor(Camrelizumab)in combination with paclitaxel + carboplatin;in the chemotherapy group,paclitaxel + carboplatin was used.Every 3 weeks was used as 1 treatment cycle,and the patients’ treatment effects were evaluated at the end of 2-4 cycles of treatment.General clinical data were collected from both groups: age,gender,smoking history,alcohol history,family genetic history,TNM stage,tumor site;imaging and pathological data: imaging clinical efficacy(PR,CR,SD,ORR,degree of tumor regression),pathological clinical efficacy(MPR and p CR);perioperative data: number of neoadjuvant treatment cycles,time from the end of last chemotherapy to the beginning of surgery The data of perioperative period were: number of neoadjuvant treatment cycles,time from the end of last chemotherapy to the beginning of surgery,R0 resection rate,surgical resection rate,operation time,intraoperative bleeding;postoperative data: incidence of adverse reactions,time of postoperative transoral fluid intake,postoperative hospital stay.SPSS 28.0 software was used for statistical analysis.P <0.05 was considered as a statistically significant difference.Result:There was no statistical difference in general information such as gender,age,history of smoking,history of alcohol consumption,family history,tumor site,T stage,N stage,and TNM clinical stage in the neoadjuvant immunotherapy combined with chemotherapy group(combined group)compared with the neoadjuvant chemotherapy alone group(chemotherapy group)(all P > 0.05).Patients in both groups underwent imaging and nuclear medicine within 4 weeks after 2-4 cycles of neoadjuvant therapy to assess the basic systemic condition.The imaging efficacy of the two groups was judged according to RECIST 1.1,and there was no statistically significant difference in PR,PD,and DCR indexes between the two groups(P > 0.05),and statistically significant difference in CR,SD,and ORR(P < 0.05).At 2-4 cycles of neoadjuvant treatment,the combination group received(2.28±0.50 vs.2.73±0.63)cycle counts compared to the chemotherapy group,with a slightly smaller mean cycle count in the combination group than in the chemotherapy group,but there was no statistically significant difference in the number of neoadjuvant cycles between the two groups(P=0.145).The time from last chemotherapy to surgery(TTS)was 21.74±1.47 days in the combination group and 22.77±1.19 days in the chemotherapy group.The surgical resection rate was 100% in both the combination and chemotherapy groups,and surgery was delayed in only one patient in the combination group due to the development of immune-associated pneumonia(delay of 8 days).Tumor regression scores in the neoadjuvant immunotherapy combined with chemotherapy group in this study were grade 0(11.6% vs.22.7%),grade 1(9.3% vs.27.3%),grade 2(25.6% vs.18.2%),grade 3(48.8% vs.18.2%),grade 4(4.7% vs.13.6%),and grade ≥2compared with the chemotherapy alone group(79.1% vs.50.0%).The proportion of patients in the combination group with tumor regression on grades 2,3,and ≥2 was greater than in the chemotherapy group,and less than in the chemotherapy group on grades 0,1,and 4.Statistically significant differences were found on grade 3 and ≥2(P < 0.05).A total of 41(95.3%)patients in the combined group underwent minimally invasive radical esophageal cancer(MIE)and 2(4.7%)patients underwent open radical esophageal cancer(OE);a total of 19(86.4%)patients in the chemotherapy group underwent MIE and 3(13.6%)patients underwent OE,with no statistically significant difference(P=0.198).The operative time in the combined group compared with the chemotherapy group was(466.05±84.65 vs 494.16±110.91)minutes for MIE and(387.50±10.61 vs 373.33±18.56)minutes for OE,and the intraoperative bleeding was(223.66±51.47 vs 211.05±54.86)ml for MIE and OE intraoperative bleeding was(220.00±28.28 vs.353.33±64.29)ml,the number of MIE lymph nodes cleared was(7.59±2.16 vs.7.26±1.79),the number of OE lymph nodes cleared was(9.00±2.83 vs.7.67±1.53),and the postoperative transoral feeding time after MIE was(7.71±1.82 vs.8.42±2.73)days,transoral feeding time after OE was(7.00±0.00 vs 9.00±2.65)days,hospitalization time after MIE was(10.61±2.14 vs 11.63±3.48)days,and hospitalization time after OE was(10.00±0.00 vs 12.33±2.31)days.There was no statistically significant difference between the two groups in terms of surgical approach,operative time,intraoperative bleeding,number of lymph nodes dissected,postoperative transoral feeding time,and postoperative hospital stay(P > 0.05).Surgery was performed 4-6 weeks after 2-4 cycles of neoadjuvant therapy,and the R0 resection rate was 100%(43/43)in the combination group was slightly higher than the R0 resection rate of 95.5%(21/22)and the R1 resection rate of 4.5%(1/22)in the chemotherapy group,with no statistical difference in the R0 resection rate between the two groups(P=0.159).In terms of pathology,a total of 65 patients who underwent surgical resection were evaluated pathologically: the p CR rate was 27.9%(12/43)and the MPR rate was 46.5%(20/43)in the combination group and the p CR rate was4.5%(1/22)and the MPR rate was 31.8%(7/22)in the chemotherapy group,both in terms of p CR rate and MPR rate,the combination group was higher than the chemotherapy group,and the the difference was statistically significant(P < 0.05).Postoperative complications are also an important consideration for neoadjuvant therapy.The incidence of pneumonia(20.9% vs.18.2%),pleural effusion(27.9% vs.31.8%),anastomotic fistula(4.7% vs.18.2%),hoarseness(7.0% vs.9.1%),and hypoproteinemia(81.4% vs.81.8%)were higher in the combined group compared with the chemotherapy group.The incidence of pneumonia,pleural effusion,anastomotic leak,hoarseness,and hypoproteinemia was less in the combination group than in the chemotherapy group,but none of the differences were statistically significant(P > 0.05).The incidence of postoperative complications was not significantly increased by neoadjuvant immunotherapy combined with chemotherapy.Conclusion:1.Neoadjuvant Camrelizumab combined with paclitaxel and carboplatin for locally advanced esophageal squamous cell carcinoma showed significant primary tumor regression,high tumor R0 resection rate,and high effectiveness.2.The low rate of adverse events associated with neoadjuvant Camrelizumab combined with paclitaxel and carboplatin,no perioperative deaths,and no increase in the incidence of postoperative complications,to some extent,suggest that neoadjuvant immune combination chemotherapy is safe and feasible.3.This study retrospectively validated the efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy,providing a new option for the first-line treatment of locally advanced esophageal cancer. |
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