Analysis Of Safety Of Neoadjuvant Concurrent Chemoradiotherapy For The Treatment Of Siewert ? And ? Local Advanced Adenocarcinoma Of The Esopha-Gogastric Junction

Objective:To investigate the safety of neoadjuvant concurrent chemoradiotherapy for the treatment of Siewert ? and ? local advanced adenocarcinoma of the esopha-gogastric junction,and to provide a reference for comprehensive evaluation of the clinical value of this treatment plan.Methods:Patients who were diagnosed with adenocarcinoma of the esopha-gogastric junction with a clinical stage of T3-4NxM0 who were diagnosed by gastroscopy and confirmed by pathology were selected from August 2012 to August 2016 in the third department of surgery of the Fourth Hospital of Hebei Medical University.A total of 109 patients were selected from the clinical study NCT01962246.Including 97 males and 12 females,aged 26-74 years,with an average age of 61 years.After admission were randomly divided into two groups:The experimental group(neoadjuvant chemoradiotherapy group): preoperative chemotherapy(XELOX protocol 2 cycles)+ radiotherapy(45Gy/25 f,5 times/week)followed by surgery,postoperative chemotherapy(XELOX protocol 6 cycles).The control group(direct surgery group): no preoperative chemoradiotherapy,direct surgical treatment,postoperative chemotherapy(XELOX regimen 8 cycles).The safety of this treatment was evaluated by assessing the safety and perioperative safety of the two groups during the engraftment/chemotherapy period.The safety observations for the radiology/chemotherapy period include: adverse hematologic and non-hematologic adverse reactions,assessed by CTCAE version 4.0.Perioperative safety observations included: preoperative nutritional risk screening,operative time,intraoperative blood loss,intraoperative edema,surgical site-related complications,and other complications,according to NRS2002,Clavien-Dindo 2009 Improved version of the standard assessment.Results:1.In the neoadjuvant radiochemotherapy group,53 patients,including 49 males and 4 females,received neoadjuvant chemoradiotherapy and received surgical treatment.This group received a total of 268 cycles of chemotherapy,each completing 3-8 cycles.The median is 5 cycles.56 patients in the direct surgery group received direct surgical treatment,including 48 males and 8 females.The group received a total of 364 cycles of chemotherapy and each completed 3-8 cycles with a median of 6.5 cycles.2.Blood system adverse reactions in the two groups mainly included: neutropenia,anemia,thrombocytopenia,and abnormal liver function.The total incidence of neutropenia in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,and the difference was statistically significant(66.0% vs 44.6%,P=0.034).There was no significant difference in the incidence of anemia,thrombocytopenia,and abnormal liver function(P>0.05).The incidence of adverse reactions of blood group 3-4 in both groups was low,and the difference was not statistically significant(P>0.05).3.Non-hematologic adverse reactions in the two groups mainly included: nausea,vomiting,diarrhea,constipation,hand-foot syndrome,and fatigue,with grades 1 to 2.The total incidence of nausea in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,and the difference was statistically significant(69.9% vs 48.2%,P=0.032).The total incidence of fatigue in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,and the difference was statistically significant(62.3% vs 39.3%,P=0.022).There was no significant difference in the total incidence of vomiting,diarrhea,constipation and hand-foot syndrome(P>0.05).The incidence of non-hematologic adverse reactions in both groups was 3-4,and the difference was not statistically significant(P>0.05).4.Radioactive gastritis/esophagitis and radiation pneumonitis were unique adverse reactions in the neoadjuvant chemoradiotherapy group.The total incidence was 43.4% and 13.2%,respectively,and the degree was mainly grade 1 to 2.5.All patients underwent nutritional risk screening before surgery,and the incidence of nutritional risk in both groups was determined by NRS2002 screening.There was no statistically significant difference between the two groups(71.70% vs 55.36%,P=0.111).6.There was no significant difference in mean operation time and mean intraoperative blood loss between the two groups(P>0.05).7.In the neoadjuvant chemoradiotherapy group,edema in the operative area was seen in some patients,but there were no cases in which surgical plans or surgery could not be performed due to edema.8.The operative complications of the two groups: incision infection,anastomotic bleeding,anastomotic leakage,abdominal infection,intestinal obstruction were not high,the difference was not statistically significant(P> 0.05).The incidence of pleural effusion in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,and the difference was statistically significant(22.64% vs 7.14%,P=0.030).The incidence of lung infection in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,and the difference was statistically significant(24.53% vs 8.93%,P=0.006).9.According to the Clavien-Dindo 2009 improved version classification,the complications of grade ? and above were mainly: pleural effusion,lung infection,and anastomotic bleeding.The incidence of grade ? or higher complications in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,but the difference was not statistically significant(13.21% vs 3.57%,P=0.088).Conclusion:1.Neoadjuvant chemoradiotherapy did not increase the incidence of grade 3-4 adverse events during radiotherapy and chemotherapy.2.Radioactive gastritis/esophagitis and radiation pneumonitis were unique adverse reactions in the neoadjuvant chemoradiotherapy group.However,the degree is grade 1 to 2 and can be tolerated.3.The preoperative nutritional risk in the neoadjuvant chemoradiotherapy group was higher than that in the direct surgery group,and it required a more complete perioperative nutritional support to improve the treatment tolerance.4.During surgery,it was found that some of the patients treated with neoadjuvant chemoradiotherapy had edema in the operative area,but did not cause changes in the surgical plan and the safety was within a controllable range.5.Neoadjuvant chemoradiotherapy did not increase the incidence of postoperative complications at grade ? and above.6.Neoadjuvant chemoradiotherapy is safe for the treatment of Siewert ? and ? locally advanced adenocarcinoma of the esophagogastric junction.Note: The above-mentioned neoadjuvant chemoradiotherapy regimen is: XELOX regimen 2 cycles + radiotherapy 45Gy/25 f,5 times/week.