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Biomarkers identified to predict benefit from maintenance erlotinib
Brugger W. J Clin Oncol. 2011:29:4113-4120.
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Those patients with advanced non-small cell lung cancer identified to have epidermal growth factor receptor mutations received the most benefit from undergoing maintenance therapy with erlotinib, according to the results of a substudy from the SATURN trial.
SATURN was a phase 3, randomized, placebo-controlled study that found the use of erlotinib maintenance therapy prolonged PFS and OS in patients with advanced NSCLC who had nonprogressive disease after initial treatment with a platinum doublet.
In this substudy, the researchers conducted a prospective analysis to identify biomarkers that had prognostic or predictive value.
All patients in the SATURN trial had to provide tissue samples.
These samples were tested for EGFR protein expression using immunohistochemistry, EGFR gene copy number using fluorescent in situ hybridization, and EGFR and KRAS mutations using DNA sequencing.
Results from the 889 patients indicated that mutations in EGFR had a significant predictive effect on PFS (HR=0.10; P<.001). In addition, those patients with wild-type EGFR had significant PFS benefits compared with the other tested markers, which had no prognostic or predictive value.
In an accompanying editorial, Frances A. Shepherd, MD, of the University Health Network, Princess Margaret Hospital and the University of Toronto expressed the continued importance of identifying patients who are most likely to benefit from maintenance therapy, whether they are identified using molecular markers or patients characteristics.
Shepherd also congratulated the researchers for requiring that all patients have tissue samples collected, nothing that approach is vital moving forward.
“It is doubtful that the one-size-fits-all approach of treating all patients with expensive chemotherapy or molecularly targeted therapies will be economically sustainable for much longer in any health care system,” Shepherd wrote.
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