Efficacy And Safety Of Anlotinib Combined With Docetaxel In Second-line Treatment Of Extensive Small Cell Lung Cancer

Objective:To investigate the efficacy and safety of anlotinib combined with docetaxel in the treatment of extensive stage small cell lung cancer(ES-SCLC).Method:A total of 117 patients with ES-SCLC who progressed or relapsed after first-line etoposide and cisplatin regimen or combined immunotherapy with etoposide and cisplatin were selected from 2020-01-01--2022-03-31Fuyang City People’s Hospital(40 cases),Fuyang Second People’s Hospital(37 cases)and Taihe Hospital of Traditional Chinese Medicine Hospital(40 cases).They were randomly divided into observation group(59 cases)and control group(58 cases)by random number table method.Observation group:patients were given anlotinib hydrochloride capsule(12mg orally,once a day,2 weeks of medication stopped for 1 week,every 21days for 1 cycle)combined with docetaxel(75mg/m2,intravenous drip 1h,d1,every21 days for 1 cycle);Control group:Patients were given docetaxel(75mg/m2,1 hour intravenously,d1,1 cycle every 21 days).The short-term efficacy,progression-free survival(PFS),overall survival(OS)and adverse reactions of the two groups were observed,and the effects of different prognostic factors on the survival of the patients were evaluated.Results:The median follow-up time was 12.5 months.The objective response rate(ORR)of the observation group and the control group were 61.0%(36/59)and 25.9%(15/58),and the disease control rate(DCR)were 91.5%(54/59)and 77.6%(45/58),respectively.The differences were statistically significant(X~2=14.700,P<0.001;X~2=4.366,P=0.037).Median PFS were 6.1 and 4.2 months,and median OS were 9.2and 6.7 months,respectively,and the differences were statistically significant(X~2=47.331,P<0.001;X~2=31.101,P<0.001);Subgroup survival analysis showed that in BMS,median PFS(4.9 months vs 3.0 months,P=0.002)and median OS(8.2months vs 3.7 months,P<0.001)were both longer in the observation group than in the control group.Univariate analysis showed that first-line immunotherapy prolonged PFS and OS in the observation group(P<0.001),and ECOG score=1 and brain metastases were associated with shorter PFS and OS(P<0.001).The factors with P<0.05 in univariate analysis were included in multivariate COX regression analysis.It was found that brain metastases,ECOG scores and first-line immunodrugs were PFS(P=0.008;P=0.002;P=0.001)and OS(P<0.001;P=0.001;P=0.004)were independent prognostic factors.The common adverse reactions were fatigue,anorexia,nausea/vomiting,leukopenia,neutropenia,etc.Hand-foot syndrome,hypothyroidism and hypertriglyceridemia in the observation group were more common in the control group,with no statistical significance,P>0.05.The incidence of hypertension in observation group was higher than that in control group,and the difference was statistically significant(P<0.05).The occurrence of adverse reactions was mainly Grade 1 to Grade 2 in the two groups,with low incidence of grade 3,no grade 4adverse reactions,and no treatment-related death,which could be controlled by symptomatic treatment or anlotinib reduction.Conclusions:Anlotinib combined with docetaxel can be used as a safe and effective second-line treatment for patients with ES-SCLC,and has a trend of improving prognosis,which is worth expanding the sample size to continue clinical research.