Abstract 1376P
Background
Anlotinib is a novel multi-target tyrosine kinase inhibitor which targets VEGFR, FGFR, PDGFR and c-kit, and approved for subsequent therapy of metastatic non-small-cell lung cancer (NSCLC) by NMPA. Docetaxol is the standard second-line chemotherapy drug for advanced NSCLC. In this phase 2, single-arm trial, we assessed the efficacy and safety of anlotinib combination with docetaxol in previously treated advanced NSCLC following platinum-based doublet chemotherapy.
Methods
Advanced NSCLC patients progressed during or after platinum-based doublet chemotherapy were assigned to treat with docetaxel at a dose of 60mg per square meter of body-surface area and anlotinib at a dose of 12mg oral per day for 2 weeks every 3 weeks. Progression free survival (PFS) was primary end point, while objective response rate (ORR), disease control rate (DCR) and safety were secondary end points. This study is registered with chictr.org.cn, number ChiCTR1800020011.
Results
In total, 27 patients were enrolled and 2 patients were excluded. Among 25 recruited patients, median age was 60 years. 20 (80.0%) patients were male, 11 (44.0%) patients were ever smokers and the ECOG performance status of 23 (92.0%) patients was 1. The histology of 7 (28.0%) patients was squamous carcinoma, while of 16 (64.0%) patients was adenocacinoma. The status of EGFR mutation, ALK and ROS1 fusion was all negative in 21 (84.0%) patients, while 4 (16.0%) patients harbored with EGFR mutation or ALK fusion. All 20 patients were included in the efficacy analysis while other 5 patients were not reached to assessment time. PFS was 4.5 months (95% CI, 3.5-5.5). The ORR was 7/20(35.0%), stable disease was 12/20(60.0%), DCR was 19/20(95.0%) and progress disease was 1/20(5.0%). The total treatment related adverse events (AE) rate with all grade was 13(52.0%) and grade 3/4 was 4(16.0%). Common AEs were fatigue 4(16.0%), hand foot skin reaction 4(16.0%), bleeding 3(12.0%), hypertension 3(12.0%) and so on. Only 4(16.0%) patients suffered from grade 3 toxicity.
Conclusions
The combination of anlotinib and docetaxol demonstrated better activity with acceptable toxicity in patients with previously treated advanced NSCLC regardless of histology type.
Clinical trial identification
ChiCTR1800020011.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.