A phase II study of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer

Abstract

Background The aim of this prospective, pilot, single‐arm phase II trial was to evaluate the safety and efficacy of anlotinib combined with etoposide and platinum‐based regimens in the first‐line treatment of extensive‐stage small cell lung cancer (ES‐SCLC). Methods This phase II study was conducted at Fudan University Shanghai Cancer Center between December 2018 and December 2020. All patients received standard chemotherapy (etoposide plus cisplatin/carboplatin) consisting of four courses and anlotinib at 12 mg once per day for 2 weeks followed by a one‐week rest. Anlotinib administration was continued until disease progression, intolerable adverse events (AEs) or patient withdrawal from the study. The primary outcome measure was progression‐free survival (PFS). The secondary outcome measures were overall survival (OS), objective control rate (ORR), disease control rate (DCR) and AEs. Results Thirty‐seven patients were included in this study, and 30 patients were eligible for efficacy analysis. ORR and DCR were 90.0% and 96.7%, respectively. The estimated PFS and OS were 6.0 months (95% CI: 1.1–11.9 months) and 14.0 months (95% CI: 8.6–19.4 months), respectively. No unexpected adverse effects were reported. Hypertension (20/37, 54.1%), anemia (16/37, 43.2%), alopecia (15/37, 40.5%), elevated transaminases (9/37, 24.3%) and alkaline phosphatase (9/37, 24.3%) were the most commonly reported AEs. Thirteen patients (35.1%) reported grade 3–5 AEs. No treatment‐related deaths occurred during this study. Conclusion The addition of anlotinib to standard etoposide/platinum chemotherapy achieved encouraging PFS and OS in previously untreated ES‐SCLC patients, with an acceptable tolerability profile and no new safety signals observed.

Investigation of the efficacy and feasibility of combined therapy of PD‐L1‐enhanced exogenous peripatetic adoptive natural killer (NK) cells in combination with antiangiogenic targeted therapy in the treatment of extensive‐stage small cell lung cancer

“…A phase II single‐arm clinical study conducted in Shanghai investigated the combination of anlotinib with either etoposide or cisplatin for ES‐SCLC 23 . The study aimed to explore the potential benefits of this combination therapy.…”

Personalized treatment of extensive stage small cell lung cancer: A case report and literature review

“…The ALTER1202 study, a randomized, double-blind, placebo-controlled multicenter phase II study of anlotinib in third-line and above treatment of SCLC, has been conducted in 2018. The results of ALTER1202 showed ( 10 , 11 ) that patients with progressive or recurrent SCLC who were treated with anlotinib after second-line treatment had significant clinical benefits compared with placebo. Patients had a favorable clinical benefit of 3.4-month improvement in PFS (HR = 0.19, p <0.0001) and 2.4-month improvement in OS (HR = 0.53, p = 0.0029) in the anlotinib group.…”

The Efficacy and Safety of Anlotinib Plus Etoposide with Cisplatin/Carboplatin in the First-Line Treatment of Lung Cancer: A Phase II Clinical Study

“…The integration of anlotinib, a potent small-smolecule tyrosine kinase inhibitor targeting VEGFR, FGFR, and PDGFR, into first-line treatment regimens alongside etoposide and platinum-based chemotherapy presents a novel approach with promising therapeutic outcomes in ES-SCLC 26 , 27 . Therefore, this trial aims to evaluate the efficacy of combining etoposide and platinum with anlotinib in ES-SCLC and assess any associated adverse effects.…”