Effectiveness and Safety of Anlotinib Monotherapy for Patients with Extensive-stage Small-Cell Lung Cancer Who Progressed to Chemotherapy: A Real-world Exploratory Study

BACKGROUND: Anlotinib demonstrated promising efficacy for patients with extensive-stage small-cell lung cancer (ES-SCLC) in clinical trials. However, the real-world evidence of anlotinib monotherapy in ES-SCLC was still limited currently. Therefore, present study was to investigate the effectiveness and safety of anlotinib for patients with ES-SCLC who progressed to chemotherapy in real-world and the potential biomarker during anlotinib monotherapy. METHODS: A total of 89 patients with ES-SCLC who failed the previous chemotherapy treatment were recruited. All the patients were administered with anlotinib monotherapy. Demographic data of the patients were collected; effectiveness and safety profile during anlotinib monotherapy were documented through electronic medical record system in the hospital. Progression-free survival (PFS) and overall survival (OS) were presented using Kaplan-Meier survival curves and multivariate analysis was adjusted by Cox regression analysis. RESULTS: All the 89 patients with ES-SCLC who progressed to chemotherapy were available for the assessment of effectiveness and safety profile. Best overall response indicated that partial response was observed in 6 patients (6.7%), stable disease was noted in 61 patients (68.5%), and progressive disease was found in 22 patients (24.7%). Therefore, the objective response rate (ORR) and disease control rate (DCR) of the 89 patients with ES-SCLC was 6.7% (95% confidence interval [CI]: 2.5%-14.1%) and 75.3% (95% CI: 65.0%-83.8%), respectively. The prognostic data suggested that the median PFS of the 89 patients was 3.1 months (95% CI: 2.10-4.10), and the median OS was 8.6 months (95% CI: 7.42-9.78). In addition, the most common adverse reactions of the patients who received anlotinib monotherapy were hypertension (34.8%), hand-foot syndrome (30.3%), fatigue (29.2%), loss of appetite (27.0%), and hematological toxicity (21.3%). Association analysis between biomarker (hypertension status) and prognosis indicated that the median PFS of patients with hypertension and patients with non-hypertension was 5.5 and 3.0 months, respectively (χ(2) = 4.64, P = .031). Furthermore, multivariate Cox analysis for PFS suggested that hypertension status was an independent factor for PFS (hazard ratio [HR] = 0.71, P = .035]. CONCLUSION: Anlotinib monotherapy showed encouraging effectiveness and acceptable safety profile for patients with ES-SCLC in real world. Hypertension induced by anlotinib administration might be used as a potential biomarker to predict superior PFS for patients with ES-SCLC.