A real-world study of anlotinib in combination with PD-L1 inhibitors plus chemotherapy as first-line therapy for extensive-stage small cell lung cancer.

e20135 Background: Current first-line treatment options for extensive stage small cell lung cancer (ES-SCLC) are the PD-L1 inhibitor in combination with chemotherapy. Although these regimens have improved outcomes, most patients experience disease progression (PD), and median survival remains approximately 12 months. Anlotinib represents a tyrosine kinase inhibitor targeting multiple receptor tyrosine kinases, achieved good efficacy in third-line therapy in ES-SCLC. We conducted a real-world study to explore the safety and efficacy of adding anlotinib to the current first-line therapy in ES-SCLC. Methods: This real-world study included 16 patients with ES-SCLC treated with antirotinib in combination with the PD-L1 inhibitor and etoposide and cisplatin chemotherapy at our hospital between Oct 2020 and Nov 2023. Patients received six cycles of a standard dose of the PD-L1 inhibitor (Atezolizumab; Adebrelimab; Envafolimab; Nivolumab; Pembrolizumab; Tirelizumab or Sugemalimab) in combination with cisplatin (25 mg/m2, day 1-3 of each cycle) and etoposide (100 mg/m2, day 1-3 of each cycle), and anlotinib was taken orally (4-6mg, day 1-14 of each cycle). Maintenance PD-L1 inhibitor plus anlotinib was followed in a 21-day cycle until disease progression, intolerant toxicity, or longer than 2 years of treatment. The primary outcomes were overall survival (OS) and progression-free survival (PFS). Secondary outcomes were disease control rate (DCR), objective response rate (ORR), and adverse reactions. Treatment response and adverse events (AEs) were assessed using the RECIST 1.1 and CTCAE 5.0, respectively. Results: A total of 16 patients were recruited. The median age was 72 years (66-76). Four patients (25%) had brain metastases at baseline, and seven patients (43.8%) had liver metastases. Median PFS was 10.8 months (95% CI, 8.3-13.3 months) and the median OS was 16.4 months (95% CI, 9.6-23.2 months). Totally 15 and 1 participants showed PR and SD, respectively. ORR and DCR were 93.8% and 100%. All patients had treatment-related AEs, of which grade 3-4 AE occurred in 50% (8/16). No serious infection or treatment-related death occurred. Myelosuppression was the most common AE, such as anemia (100%), leukocytopenia (100%), lymphocytopenia (100%), neutropenia (87.5%), and thrombocytopenia (50%). Other common AEs included hypoproteinemia (68.8%); hyponatremia (62.5%); creatinine elevation (56.3%), proteinuria (43.8%); hypertension (37.5%) and hypertriglyceridemia (37.5%). No unexpected AEs were found in this study. No patient stopped treatment due to intolerable toxicity. Conclusions: The addition of anlotinib to first-line immunotherapy in combination with chemotherapy results in extended PFS and OS in patients with ES-SCLC without additional AEs. The preliminary results warrant further investigation of this treatment modality in ES-SCLC.