Everolimus fails to boost advanced NSCLC response

By Lynda Williams, Senior medwireNews Reporter

Phase II trial findings have ruled out a combination of erlotinib and everolimus for advanced non-small-cell lung cancer (NSCLC) patients with progression after chemotherapy.

The study did not show a large enough difference in tumor stabilization between patients randomly assigned to receive open-label erlotinib 150 mg/day alone and those who were also given the mammalian target of rapamycin inhibitor, everolimus 5 mg/day, to continue investigations.

The 3-month disease control rate (DCR) was 28.4% for the 67 patients given erlotinib versus 39.4% for the 66 patients given the combination regimen, giving a 29.8% probability of a 15% or higher difference in disease control for the two treatments.

Thus, erlotinib plus everolimus did not meet the prespecified threshold of 40% or above, say Benjamin Besse (Institut Gustave Roussy, Villejuif, France) and co-authors in the Annals of Oncology.

Progression-free survival was also comparable, at an average of 2.0 months with erlotinib alone and 2.9 months with erlotinib plus everolimus.

But patients given only erlotinib had a significantly lower rate of grade 3 or 4 adverse events (32.3 vs 72.7%). In particular, 31.8% of patients given combination treatment developed grade 3 or 4 stomatitis compared with none of the patients given erlotinib alone.

“Overall, this study suggests that administering combination therapy with everolimus and erlotinib to patients with advanced NSCLC does not warrant further study in a molecularly unselected population, as it led to detrimental toxicity and no improvement in disease stabilization,” Besse et al conclude.

However, the team notes that the trial was performed before systematic epidermal growth factor receptor genetic profiling was regularly performed and that it is possible patient subgroups could benefit from the combined treatment.

“To hasten identification and validation of potential biomarkers in NSCLC, future trials should incorporate mandatory tissue sampling,” they add.

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