Han B, et al. - A multicenter, double-blind, randomized phase trial was conducted to test the effectiveness of anlotinib on overall survival of patients with advanced non–small cell lung cancer (NSCLC) progressing following second-line or further treatment. According to the findings, anlotinib seems to lead to prolonged overall and progression-free survival among Chinese patients. Data revealed that anlotinib is well tolerated and is has potential as a third-line or further therapy for patients with advanced NSCLC. Hypertension and hyponatremia were the most common grade 3 or higher adverse events in the anlotinib arm.

Methods

• Between March 1, 2015 and August 31, 2016, patients from 31 grade-A tertiary hospitals in China were recruited.
• Study participants aged 18 to 75 years who had histologically or cytologically confirmed NSCLC were eligible (n = 606).
• Researchers excluded those who had centrally located squamous cell carcinoma with cavitary features or brain metastases that were uncontrolled or controlled for less than 2 months.
• They randomly assigned patients (n = 440) in a 2-to-1 ratio to receive either 12 mg/d of anlotinib or a matched placebo.
• All cases in this investigation were treated with study drugs at least once in accordance with the intention-to-treat principle.
• Overall survival was the primary end point; progression-free survival, objective response rate, disease control rate, quality of life, and safety were the secondary end points.

Results

• According to the findings, 439 patients were randomized, 296 to the anlotinib group (106 [36.1%] were female and 188 [64.0%] were male, with a mean [SD] age of 57.9 [9.1] years) and 143 to the placebo group (46 [32.2%] were female and 97 [67.8%] were male, with a mean [SD] age of 56.8 [9.1] years).
• As compared to placebo group (median, 6.3 months; 95% CI, 5.0-8.1), overall survival was significantly longer in the anlotinib group (median, 9.6 months; 95% CI, 8.2-10.6), with a hazard ratio (HR) of 0.68 (95% CI, 0.54-0.87; P=.002).
• Compared with the placebo group (median, 5.4 months [95% CI, 4.4-5.6] vs 1.4 months [95% CI, 1.1-1.5]; HR, 0.25 [95% CI, 0.19-0.31]; P < .001), a substantial increase in progression-free survival was noted in the anlotinib group.
• In the anlotinib group vs the placebo group, considerable improvement in objective response rate and disease control rate was observed.
• Hypertension and hyponatremia were the most common grade 3 or higher adverse events in the anlotinib arm.