Final results from the phase 3 OPTIMAL trial showed that patients with mutant type epidermal growth factor receptor (EGFR) showed significant overall survival (OS) benefit when treated with EGFR and tyrosine-kinase inhibitor (TKI) erlotinib.

The study suggested that erlotinib should be considered standard first-line treatment for EGFR mutant patients with non-small cell lung cancer (NSCLC), stated an article published online ahead of print in the Annals of Oncology

The OPTIMAL study compared the efficacy and tolerability of EGFR-TKI erlotinib versus standard chemotherapy in first-line treatment of patients with EGFR mutation-positive advanced NSCLC.


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Out of 165 randomized patients, 82 received erlotinib and 72 gemcitabine plus carboplatin. Final analyses were performed following the death of 70% of patients in the intent-to-treat population.

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There were no significant between-group differences in the overall population, the exon 19 deletion subpopulation, or the exon 21 L858 mutation population.

Those who received sequential combination of EGFR-TKI with chemotherapy had significant improvement in OS compared with those who received either monotherapy with EGFR-TKI or chemotherapy (29.7 months, 20.7, and 11.2, respectively).