Anlotinib plus platinum‐etoposide as a first‐line treatment for extensive‐stage small cell lung cancer: A single‐arm trial

Abstract Background Anlotinib as a third‐line or beyond therapy for extensive‐stage small‐cell lung cancer (ES‐SCLC) was studied. This single‐arm phase II trial was to investigate the value of anlotinib plus platinum‐etoposide as first‐line treatment in ES SCLC. Methods The primary endpoint was progression‐free survival (PFS) and objective response rate (ORR). The secondary endpoints included overall survival (OS), disease control rate (DCR), time to progression (TTP), duration of remission (DoR), and safety. The subgroups of preset liver metastasis and brain metastasis were analyzed. Results In 35 ES‐SCLC patients, the median PFS, ORR, DCR, and OS were 8.02 months [95% confidence interval (CI): 6.90–9.66], 85.71% (95% CI: 69.74–95.19), 94.29% (95% CI: 80.84–99.30), and 15.87 months (95% CI: 10.38–18.89), respectively. The median PFS in the liver metastasis and brain metastasis subgroups was 7.33 months (95% CI: 4.76–9.69) and 7.34 months (95% CI: 5.68–9.20), respectively. The most common AEs with grade 3–4 were hand–foot syndrome (17%), granulocytosis (17%), stomatitis (14%), hypertriglyceridemia (11%), hypercholesterolemia (11%), as well as nausea and vomiting (11%), and no grade 5 AEs were recorded. Conclusions Anlotinib combined with platinum‐etoposide provided an effective and safe therapy for patients with ES‐SCLC.