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New Guideline Advances Standardization of EGFR Mutation and ALK-Rearrangement Testing in Lung Cancer

Posted on November 20, 2014 by J Seabrook

New guidance, endorsed by ASCO, outlines patient selection criteria for treatment of advanced-stage lung adenocarcinoma or tumors with an adenocarcinoma component with EGFR or ALK inhibitors based on EFGR mutation and ALK rearrangement. The guideline also provides laboratories direction on testing methodology.

The guidelines developed in 2013 by a joint group of pathology and medical oncology experts from Association for Molecular Pathology (AMP) , College of American Pathologists ( CAP) and International Association for the Study of Lung Cancer (IASLC) is published in this month's Journal Clinical Oncology 2014 Nov 10;32(32):3673-9 and comprises 37 recommendations.

Testing for EGFR mutation and ALK rearrangement should be offered to all patients with advanced-stage lung adenocarcinoma or other histological subtype containing adenocarcinoma, regardless of clinical characteristics, such as smoking history, sex or ethnicity. EGFR mutation by PCR [order P EGFR] and ALK rearrangement testing [order F ALK] should be ordered at time of diagnosis when presenting with advanced stage disease or as soon as a diagnosis of adenocarcinoma is established. EGFR copy number by FISH or CISH is not recommended. However, ALK by IHC can be used as a screening test with reflex to FISH. Only FISH results should be used to select patients for ALK TKI therapy. As far as prioritization of assays, EGFR mutation should be performed prior to ALK rearrangement. Other proposed markers (e.g ROS1, RET) have insufficient evidence to support testing guideline development at this time.


Leighl NB et al. 2014. Molecular testing for selection of patients with lung cancer for epidermal growth factor receptor and anaplastic lymphoma kinase tyrosine kinase inhibitors: american society of clinical oncology endorsement of the college of american pathologists/international association for the study of lung cancer/association for molecular pathology guideline. J Clin Oncol.Nov 10;32(32):3673-9

Lindeman NI, Cagle PT, Beasley MB, et al. 2013. Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Arch Pathol Lab Med. Jun;137(6):828-60.

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