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 [HR]: 0.93; 95% CI, 0.77-1.12; P =.44). The corresponding overall survival rates were 8.7 and 7.9 months (difference: 0.9 months; HR: 1.05; 95% CI, 0.85-1.30; P =.64). The objective response rates were 20.1 and 13.7%, respectively (difference: 6.4%; odds ratio, 1.61; 95% CI, 1.00-2.62; P =.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.
Disclosures: 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.
Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, et al. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non–Small Cell Lung CancerThe SELECT-1 Randomized Clinical Trial. JAMA. 2017;317(18):1844-1853. doi:10.1001/jama.2017.3438