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

Updated: Jun 05, 2020
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Clinical trial data demonstrate that patients who are tested for these abnormalities and treated with the appropriate targeted therapy have better outcomes. [57] Targeted agents currently available include epidermal growth factor receptor (EGFR) inhibitors (eg, erlotinib, gefitinib) and anaplastic lymphoma kinase (ALK) inhibitors (ie, crizotinib, ceritinib). Various other targeted agents are in the late stages of development.

In May 2013, the US Food and Drug Administration (FDA) approved of 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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