Efficacy And Safety Of Adjuvant Targeted Therapy Versus Chemotherapy After Surgery For Stage ⅠB-ⅢA NSCLC

ObjectiveLung cancer currently leads the world in terms of morbidity as well as mortality among malignancies,and non-small cell lung cancer(NSCLC)accounts for approximately 85% of all its histological subtypes,and the treatment of NSCLC is a top priority in the management of lung cancer.Radical surgery is the standard of care for patients with stage I-IIIA NSCLC,but treatment of the malignancy should not be limited to the removal of the lesion alone;only systemic systemic therapy is an effective option.This is why some patients with NSCLC who have risk factors for radical surgical resection require post-operative pharmacological or other forms of treatment to further improve long-term survival,which are referred to as adjuvant therapies.However,recent systematic reviews and other analyses have shown that the benefits of post-operative adjuvant therapy are low,reducing the risk of disease recurrence or death by only 16% and improving overall survival by only 4%-5% at 5 years.With the development of genetic testing technology,there have been impressive gains in the treatment of advanced NSCLC with targeted therapies,with results from the AURA and AURA2 trials pointing to an impressive OS of 26.8 months for patients with advanced NSCLC treated with second-line ositinib,with 12 and 24 month survival rates of 83% and 59% respectively.However,these advances have not yet been successfully applied to patients with resectable NSCLC requiring post-operative adjuvant therapy,as they currently stop at patients with advanced or locally advanced NSCLS.In response to the current situation,large clinical trials have been conducted to confirm the efficacy and safety of targeted adjuvant therapy and its advantages over conventional chemotherapy.However,as there are few clinical outcomes and safety analyses,this paper investigates the efficacy and safety of adjuvant monotherapy in patients with EGFR-positive mutations after surgery for NSCLC.MethodsThe clinical data of 82 patients with non-small cell lung cancer attending the Second Hospital of Dalian Medical University between February 2014 and December 2021 were retrospectively analyzed.The included patients were divided into targeted monotherapy and chemotherapy adjuvant treatment groups according to their adjuvant treatment regimens,and the clinical data were recorded separately.Patients with stage IB to IIIA disease were statistically assessed according to the study objectives,with the primary endpoint being disease-free survival.Secondary endpoints included disease-free survival,overall survival and safety in the overall population of patients with stage Ⅱ to ⅢA disease.Median disease-free survival was assessed for both groups.And subgroup analyses between the two groups were performed to assess treatment advantage.Patient disease-free survival was estimated using the KaplanMeier method.Point estimates of disease-free survival for both groups were calculated using the Kaplan-Meier method,and baseline and within-group data were compared between the two groups using the χ~2 test.HR and 95% CI were estimated using a Cox proportional risk regression model,and curve correlations between the two groups were estimated using the Log Rank method,with P < 0.05 indicating a statistically significant difference.Predefined subgroup analyses of disease-free survival by gender,smoking status,tumour stage,lymph node status and pathological grade were performed using the same methods.Results1.82 patients in the ⅠB-ⅢA group were statistically analysed and a total of 26 patients experienced tumour progression or death.A total of 8(20%)of the 40 patients in the targeted therapy group experienced tumour progression or death by the end of the 36-month follow-up period,and a total of 18(42.9%)of the 42 patients in the chemotherapy group experienced tumour progression or death.In both groups,the disease-free survival(DFS)rate was 73% in the targeted group and 56% in the chemotherapy group as at the end of the follow-up period,with a significantly higher DFS in the targeted treatment group compared to the chemotherapy group and a difference in disease-free survival of 17% between the two groups(HR,0.404;95% CI,0.172-1.658;p=0.037).2.Analysis of subgroups,in a statistical analysis of 43 patients with stage Ⅱ to ⅢA disease,showed a disease free survival rate of 50.9% in the targeted therapy group and 36.7% in the chemotherapy group DFS by the end of the follow-up period,with an improved DFS in the targeted therapy group compared to the chemotherapy group DFS and a difference in disease free survival of 14.2% between the two groups(HR,0.510;95% CI,0.206-1.266;p=0.147).3.In this trial,a total of 26(65%)of 40 patients in the targeted monotherapy group and 31(73.8%)of 42 patients in the chemotherapy group had any grade related adverse events observed.The incidence of serious adverse reactions was 10% in the targeted therapy group and 21.4% in the chemotherapy-adjuvant group.The incidence of adverse reactions and serious adverse events was lower in the targeted therapy group compared to the chemotherapy group.Conclusion1.Targeted therapy in patients with resectable stage ⅠB-ⅢA NSCLC has better efficacy and longer survival compared to chemotherapy.2.For patients with resectable stage ⅠB-ⅢA NSCLC,targeted therapy had fewer and less severe adverse effects compared with chemotherapy,and was significantly safer and more tolerable.3.For the subgroup of patients with resectable stage ⅡB-ⅢA NSCLC,we were able to observe that the efficacy of targeted drug therapy still prevailed in both groups.