How are molecular testing results used to guide treatment for non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Answer

In 2013, the US Food and Drug Administration (FDA) approved the cobas EGFR Mutation Test, a companion diagnostic for erlotinib. [58] This is the first FDA-approved companion diagnostic that can detect EGFR gene mutations. The mutation test allows physicians to identify patients with NSCLC who are candidates for receiving erlotinib as first-line therapy.

The safety and effectiveness of the cobas EGFR Mutation Test was established with clinical data from the EURTAC study and showed progression-free survival in patients with NSCLC who had specific types of EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations) for 10.4 months when they received erlotinib treatment, compared with 5.4 months for those who received standard therapy. [59]

Testing for Ras mutation can also be done. Ras mutation is a marker for aggressive disease and poor prognosis. New agents and regimens to target this mutation (eg, selumetinib plus docetaxel [60] ) are currently under development, so these patients should be considered for enrollment in a clinical trial.

For more information, see Genetics of Non-Small Cell Lung Cancer.


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