Abstract 1180P
Background
The standard treatment for patients with good performance status with unresectable LANSCLC is concurrent chemoradiotherapy (CRT), The new treatment strategies of patients who could not tolerate CRT or refused chemotherapy are necessary. Anlotinib is a novel multi-target antiangiogenesis agent that inhibits VEGFR, FGFR, PDGFR, c-kit, which showed encouraging efficacy and good tolerability for advanced NSCLC in ALTER-0303 trial. Emerging clinical data suggested that antiangiogenic drugs could enhance the efficacy of radiotherapy by alleviating tumor hypoxia and improving perfusion. In this trial, we assessed the efficacy and safety of anlotinib combined with radiotherapy in unresectable LANSCLC.
Methods
In the phase II trial, patients with driver gene negative unresectable LANSCLC who could not tolerate CRT or refused chemotherapy were enrolled. Eligible patients were previously untreated with immune checkpoint inhibitors. All included patients received anlotinib (12mg, QD, day 1 to 14 of a 21-day cycle) and radiotherapy (60-66Gy/30-33F, 5F/W, 6-7W) until disease progression or treatment intolerance. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). PFS, OS and safety were secondary endpoints.
Results
At data cut-off (Dec 20, 2020), we recruited 18 patients in this trial, of which 16 patients were evaluable. Complete response was observed in 1 patient, partial responses in 8, and stable disease in 7. The ORR was 56.25% (9/16), and the DCR was 100% (16/16). The median PFS and OS were not reached. The PFS rates at 6 and 12 months were 100% and 80.81% (95CI, 42.35%-94.85%), respectively. The OS rates at 6 and 12 months were 100% and 90% (95CI, 47.28%-98.53%), respectively. The most common grade 1-2 adverse events (AEs) were hand and foot skin reaction (4/16, 25%). Grade 3 or higher AEs included hypertension (1/16, 6.25%), oral mucositis (1/16, 6.25%) and hemoptysis (1/16, 6.25%).
Conclusions
Anlotinib combined with radiotherapy showed the promising ORR and DCR in patients with unresectable LANSCLC, and the combination was well-tolerated. The phase II trial is ongoing to furtherly evaluate the PFS and OS outcomes.
Clinical trial identification
ChiCTR2100043364.
Editorial acknowledgement
Legal entity responsible for the study
Baoji Gaoxin Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.