Phase Ⅱ Clinical Study Of Anlotinib In Combination With Radiotherapy In The Treatment Of Extensive-Stage Small-Cell Lung Cancer After Failure Of Second Chemotherapy

Objectives: A single-arm phase II clinical study of anlotinib combined with radiotherapy in 27 patients with extensive stage small cell lung cancer who failed second-line therapy was conducted to investigate whether anlotinib combined with radiotherapy would provide survival benefit and improvement in quality of life for patients with third-line ES-SCLC,and to evaluate the safety of this treatment regimen.Methods:27 third-line ES-SCLC patients who have≤3 metastatic organs were treated with radiotherapy based on anlotinib.Kaplan-Meier curve was used to estimate the overall survival(OS)and progression-free survival(PFS),descriptive statistical analysis was used to evaluate the safety,and EORTC QLQ-C30 was used to evaluate the quality of life.Results:Among the 27 patients,4 achieved partial remission,17 had stable disease and 6 had progression of disease.the objective remission rate(ORR)was14.81%,and the disease control rate(DCR)was 77.78%.Median PFS and the median OS were 5 months and 11 months,respectively.The most common adverse reactions included fatigue(33.3%),anorexia(14.8%),bleeding(14.8%)and hand-foot syndrome(11.1%).Most of them were grade 1 to grade 2,3 cases were more than grade 3,and there was no grade 5 toxicity recorded.The treatment regimen of anlotinib combined with radiotherapy resulted in significant improvements in overall health status,somatic function,social function,and emotional function(P<0.05).Symptoms of pain,shortness of breath,and loss of appetite improved significantly(P<0.05).Conclusions:This study demonstrates that anlotinib combined with radiotherapy is a safe and effective option for third-line ES-SCLC,which can significantly prolong the survival of this group of patients and has positive implications for improving the quality of life of patients,and is a combination treatment option worth further exploration.