Abstract 1386P
Background
The prognosis of non-small-cell lung cancer (NSCLC) patients with driver gene wild type or positive and drug resistance combined with multiple brain metastases is still poor. Radiotherapy combined with anti-angiogenesis drugs may be a promising treatment option. Anlotinib had significantly improved progression-free survival (PFS) and overall survival (OS) of advanced NSCLC in ALTER0303 trial. This study aimed to evaluate the efficacy and safety of anlotinib combined with WBRT in patients with brain metastases (>3) from advanced NSCLC.
Methods
Advanced NSCLC patients with brain metastases (>3) who were histologically confirmed to be driver gene wild type or positive (resistance after standard therapy) were treated with anlotinib (12 mg, QD, day 1 to 14 of a 21-day cycle) combined with WBRT (DT 30Gy/12 times) until disease progression or treatment intolerance. The primary endpoint was intracranial progression-free survival (iPFS). OS, PFS and toxicity were secondary endpoints.
Results
At data cut-off (April 30, 2020), we recruited 20 patients in this trial, of which 10 patients were evaluable. Among the 10 patients, 6 patients experienced partial response (PR) and 3 patients had stable disease (SD) in intracranial evaluation, and PR was achieved by 1 patient and SD exhibited by 8 patients in extracranial evaluation. The median iPFS was not reached and the six-month iPFS rate was 87.5% (95%CI, 67.3%-100%). The median extracranial PFS was 8.7 months (95%CI, 3.52-13.87). The objective response rate (ORR) and the disease control rate (DCR) were 60.0% and 90.0% in intracranial evaluation, respectively. The extracranial ORR was 10.0%, and DCR was 90.0%. Most common grade 1-2 adverse events (AEs) were hypertension (60%), fatigue (50%) and anorexia (40%). 2 patients (20%) suffered from grade 3 AEs, which were hypertension and hand-foot syndrome, respectively. No intracranial hemorrhage occurred during treatment.
Conclusions
The combination of anlotinib and WBRT exhibited significantly therapeutic efficacy and manageable AEs, which might be a promising option for patients with advanced NSCLC with multiple brain metastases.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Xiangzhi Zhu.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.