A phase II study of anlotinib in 45 patients with relapsed small cell lung cancer.

The purpose of this prospective phase II clinical trial was to investigate the efficacy and safety of anlotinib in patients with relapsed small cell lung cancer (SCLC). Forty‐five patients with relapsed SCLC were enrolled and treated with anlotinib (one cycle of 12 mg daily for 14 days, discontinued for 7 days, and repeated every 21 days) until disease progression or intolerance of treatment. The primary end point was progression‐free survival (PFS). Secondary end points were overall survival (OS), disease control rate (DCR), objective control rate (ORR) and toxicity. The median PFS was 4.1 months (95% confidence interval [CI] 2.4‐5.8) and the median OS was 6.1 months (95% CI 2.2‐10.0). The OS for the limited‐stage subgroup was significantly longer than that of the extensive‐stage subgroup (P =.02). The DCR was 67%, and the ORR was 11%. The most common adverse event was hypertension (13%), which was controlled well with antihypertensive drugs. In conclusion, anlotinib has likely efficacy in patients with relapsed SCLC, and the side effects can be well tolerated. A longer OS was observed in limited‐stage SCLC patients treated with anlotinib. What's new? Although untreated small cell lung cancer (SCLC) patients are usually sensitive to chemotherapy, they are prone to relapse. Anlotinib is a novel multi‐target small molecule tyrosine kinase inhibitor with both anti‐angiogenesis and anti‐tumor growth effects. While anlotinib became the first drug approved for third‐line and further‐line treatment of SCLC in China, few studies have focused on anlotinib treatment in relapsed SCLC. This one‐arm, prospective phase II clinical study reports a median progression‐free survival of 4.1 months (95% CI 2.4‐5.8) and median overall survival of 6.1 months (95% CI 2.2‐10.0) for anlotinib treatment in relapsed SCLC, with relatively mild side effects. [ABSTRACT FROM AUTHOR]