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Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre,
Baohui Han1, Kai Li2, Yizhuo Zhao1
1Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 230030, China.
Background:
Anlotinib (AL3818) is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer (RA-NSCLC).
Methods:
Eligible patients were randomised 1 : 1 to receive anlotinib (12 mg per day, per os; days 1-14; 21 days per cycle) or a placebo. The primary end point was progression-free survival (PFS).
Results:
A total of 117 eligible patients enrolled from 13 clinical centres in China were analysed in the full analysis set. No patients received immune check-point inhibitors and epidermal growth factor receptor status was unknown in 60.7% of the population. PFS was better with anlotinib compared with the placebo (4.8 vs 1.2 months; hazard ratio (HR)=0.32; 95% confidence interval (CI), 0.20-0.51; P<0.0001), as well as overall response rate (ORR) (10.0%; 95% CI, 2.4-17.6% vs 0%; 95% CI, 0-6.27%; P=0.028). The median overall survival (OS) was 9.3 months (95% CI, 6.8-15.1) for the anlotinib group and 6.3 months (95% CI, 4.3-10.5) for the placebo group (HR=0.78; 95% CI, 0.51-1.18; P=0.2316). Adverse events were more frequent in the anlotinib than the placebo group. The percentage of grade 3-4 treatment-related adverse events was 21.67% in the anlotinib group.
Conclusions:
Anlotinib as a third-line treatment provided significant PFS benefits to patients with RA-NSCLC when compared with the placebo, and the toxicity profiles showed good tolerance.
Insights
Third-line anlotinib significantly improved progression-free survival in refractory advanced non-small-cell lung cancer patients compared to placebo. The treatment demonstrated a favorable safety profile with manageable adverse events.
Area of Science:
- Oncology
- Pharmacology
Background:
- Anlotinib is a novel multitarget tyrosine kinase inhibitor targeting tumor angiogenesis and proliferation.
- Refractory advanced non-small-cell lung cancer (RA-NSCLC) presents a significant therapeutic challenge.
Purpose of the Study:
- To evaluate the safety and efficacy of third-line anlotinib in patients with RA-NSCLC.
- To compare progression-free survival (PFS) and overall response rate (ORR) between anlotinib and placebo.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 117 patients with RA-NSCLC.
- Patients received either anlotinib (12 mg/day) or placebo for 14 days every 21-day cycle.
- The primary endpoint was progression-free survival (PFS).
Main Results:
- Anlotinib significantly improved PFS (4.8 vs 1.2 months; HR=0.32; P<0.0001) and ORR (10.0% vs 0%; P=0.028) compared to placebo.
- Median overall survival (OS) was 9.3 months with anlotinib versus 6.3 months with placebo (HR=0.78; P=0.2316).
- Grade 3-4 treatment-related adverse events occurred in 21.67% of patients receiving anlotinib.
Conclusions:
- Third-line anlotinib demonstrates significant efficacy in improving PFS for patients with RA-NSCLC.
- Anlotinib exhibits a manageable toxicity profile and good tolerability in this patient population.
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