HealthDay News — The addition of selumetinib to docetaxel does not improve progression-free survival among patients with previously treated advanced KRAS-mutant non-small-cell lung cancer (NSCLC), according to a study published in the May 9 issue of the Journal of the American Medical Association.
Pasi A. Jänne, MD, from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a multicenter randomized trial across 25 countries involving 510 patients with advanced KRAS-mutant NSCLC. Disease progression following first-line anticancer therapy was assessed. Patients were randomized to selumetinib + docetaxel or placebo + docetaxel (251 and 254 patients, respectively, received treatment).
The researchers found that 88% of patients had experienced a progression event at the time of data cut-off, and deaths had occurred in 68%. For selumetinib + docetaxel and placebo + docetaxel, median progression-free survival was 3.9 and 2.8 months, respectively (difference, 1.1 months; hazard ratio, 0.93; 95% confidence interval, 0.77 to 1.12; P=0.44). The corresponding overall survival rates were 8.7 and 7.9 months (difference, 0.9 months; hazard ratio, 1.05; 95% confidence interval, 0.85 to 1.30; P=0.64). The objective response rates were 20.1 and 13.7%, respectively (difference, 6.4 percent; odds ratio, 1.61; 95% confidence interval, 1.00 to 2.62; P=0.05).
“Among patients with previously treated advanced KRAS-mutant non-small-cell lung cancer, addition of selumetinib to docetaxel did not improve progression-free survival compared with docetaxel alone,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca, which funded the study. Roche Molecular Systems provided management in testing the formalin-fixed, paraffin-embedded tissue samples.