Perioperative Safety And Feasibility Outcomes Of Stage ⅢA-N2 Non-small Cell Lung Cancer Following Neoadjuvant Therapy

Background: At present,the rise of neoadjuvant immunotherapy has attracted widespread attention,but the experience of surgical treatment after neoadjuvant therapy is relatively lacking.Therefore,the research treated patients suffering from stage IIIA-N2 non-small cell lung cancer(NSCLC)with neoadjuvant therapy to determine their perioperative safety and feasibility.Methods: The study collected patients with stage IIIA-N2 NSCLC who received neoadjuvant immunotherapy or chemotherapy in Qingdao University Affiliated Hospital between September 2019 and December 2020.We retrospectively analyzed the clinical baseline data,histopathological characteristics,neoadjuvant treatment regimens and outcomes of all patients.At the same time,the operation interval,operation time,blood loss,R0 resection rate,30-day postoperative mortality and morbidity of complications,postoperative pathological results and other data of 102 patients undergoing surgical treatment were also counted.The primary endpoint of the study was the risk of major complications within 30 days after surgery and the R0 resection rate,and the secondary endpoints were surgical interval and 30-day postoperative mortality.All statistical analyses were performed using R language software(R 4.0.3).And all statistical tests were two-sided.P< 0.05 was considered statistically significant.Results: A total of 107 eligible patients were evaluated of whom 25 were allocated to the neoadjuvant immunotherapy group and 82 to the neoadjuvant chemotherapy group.One or four patients chose other treatment options due to disease progression in the neoadjuvant immunotherapy group or the neoadjuvant chemotherapy group,respectively.Twenty-four patients underwent surgery in the neoadjuvant immunotherapy group and 78 patients underwent surgery in the neoadjuvant chemotherapy group.Most patients in this study met the primary and secondary endpoints.There was no statistical difference in the median operation interval between the two groups(P= 0.656).The median operation interval was 29.2 days(95% confidence interval: 27.1-31.4)or 28.7days(95% confidence interval: 27.6-29.8)in the neoadjuvant immunotherapy group or the neoadjuvant chemotherapy group,respectively.Although most patients experienced treatment-related adverse events,there are 25 patients completed two cycles of therapy in the neoadjuvant immunotherapy group and 80 patients in the neoadjuvant chemotherapy group completed two cycles of therapy.In addition,when it comes to the probability of complications of grade three and four within 30 days after surgery,there was no statistically significant difference between the two groups(P= 0.757).The major pathological response(MPR)rate of neoadjuvant immunotherapy patients was not lower than that of neoadjuvant chemotherapy patients(P= 0.023).Conclusion: This study demonstrates that neoadjuvant immunotherapy or chemotherapy for resectable stage IIIA-N2 NSCLC followed by pneumonectomy is safe and feasible,with low mortality and morbidity within 30 days after surgery.Compared with neoadjuvant chemotherapy,we found that neoadjuvant immunotherapy was non-inferior to neoadjuvant chemotherapy in terms of MPR.