The Clinical Efficacy Analysis of Combining Anlotinib with Gefitinib as A First-line Treatment for EGFR-positive Advanced Non-small Cell Lung Cancer
Objective:To explore the clinical efficacy and safety of the combination of the anti-angiogenic agent Anlotinib and Gefitinib as first-line treatment for advanced non-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)-sensitive mutations.Method:A total of 21 patients with advanced NSCLC who were diagnosed and treated at the Department of Oncology,the First People's Hospital of Lianyungang from May 2019 to February 2021 were included in this study,the patients had not received prior treatment,and were EGFR mutation-positive(exon 19 deletion or 21L858R).They were treated with Anlotinib and Gefitinib,until disease progression or intolerable toxic side effects occurred.The primary endpoint was progression-free survival(PFS),and the secondary endpoints were objective response rate(ORR),disease control rate(DCR),overall survival(OS),and safety.Result:The first follow-up was conducted until March 2021.The results showed that among the patients receiving the combination treatment,there were 13 cases of partial remission(PR),with an ORR of 61.9%,7 cases of progressive disease(PD),and 1 case lost to follow-up.The median PFS was 15.7 months[95%CI(9.4,22.1)].Follow-up continued until September 2022,with 10 cases of PR,2 cases of stable disease(SD),an ORR of 47.62%,a DCR of 57.14%,4 cases of PD,5 cases lost to follow-up or death,and a median PFS of 27.1 months[95%CI(22.9,31.2)].The 2-year OS rate was 66.70%,and the median OS was not reached,indicating a relatively high overall survival rate among the patients.Cox multivariate regression analysis showed that KPS score[HR=0.696,95%CI(0.537,0.902),P=0.006]was an independent prognostic factor for the first-line treatment of EGFR-positive advanced NSCLC using this combination therapy.The most common treatment-related adverse events(TRAEs)were rash(47.62%),hypertension(33.33%),hyperlipidemia(19.05%),and hand-foot skin reaction(19.05%),proteinuria,diarrhea,and other adverse events.Conclusion:The combination of Anlotinib and Gefitinib has demonstrated good efficacy and controllable safety in patients with advanced NSCLC with EGFR mutations.