Abstract 1336P
Background
Elderly pts have limited therapy strategies compared to the younger pts. Anlotinib is a novel multi Tyrosine Kinase Inhibitor targeting the VEGFR, FGFR, PDGFR and c-Kit. In elderly pts subgroup of ALTER0303 trial (NCT02388919), significant advances in OS and PFS were found in anlotinib treated group with tolerable AE. In this trial, we assessed the efficacy and safety of anlotinib in elderly patients with advanced non-squamous NSCLC who had not received systemic chemotherapy.
Methods
In the phase II trial, Pts with non-squamous non-small cell lung cancer (NSCLC) aged 70 years or older who had not received systemic chemotherapy were included. Pts harboring EGFR or ALK mutations were enrolled after the failure of TKIs therapy. All included patients received anlotinib (12mg, QD, day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. The primary endpoints was PFS. ORR, DCR, OS and safety were secondary endpoints.
Results
At data cut-off (Apr 21, 2021), we recruited 41 patients in this trial, of which 19 patients were evaluable. The median age of patients was 75 years and 57.9% were female. The median PFS was 5.2 months (95% CI: 2.8-7.6) and the median OS was not reached, The ORR was 0% (0/19), and the DCR was 89.5% (17/19). The most common grade 1-2 adverse events (AEs) were hypertension (6/19, 31.6%). Grade 3 or higher AEs included Hand and foot skin reaction (1/19, 5.3%), Sore throat (1/19, 5.3%) and pulmonary infection (1/19, 5.3%).
Conclusions
Anlotinib appears to be feasible and safe in patients over 70 years of age, with advanced non-squamous NSCLC who had not received systemic chemotherapy. The study continues recruitment.
Clinical trial identification
NCT03778853.
Editorial acknowledgement
Legal entity responsible for the study
The First Hospital of Lanzhou University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.