Lynette M. Sholl, MD, and Geoffrey R. Oxnard, MD, prepared useful practice aids pertaining to EGFR mutation-positive lung cancer in this CME/MOC activity titled "Molecular Testing for EGFR Mutations in the Context of a Changing Treatment Landscape, Evolving Testing Options, and Updated Guidelines: What Pathologists Need to Know and Do." For the full presentation, monograph, complete CME/MOC information, and to apply for credit, please visit us at http://bit.ly/2sPyPNn. CME/MOC credit will be available until February 5, 2020.

1. This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
EGFR TKIs Approved for Treatment of
Advanced EGFR Mutation-Positive NSCLC1,2
mut: mutation; wt: wild-type.
1. Ko B et al. Lung Cancer (Auckl). 2017;8:147-159. 2. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Accessed January 29, 2019.
PRACTICE AID
Access the activity, “Molecular Testing for EGFR Mutations in the Context of a Changing Treatment
Landscape, Evolving Testing Options, and New Guidelines: What Pathologists Need to Know and Do,”
at www.peerview.com/DZD40.
Indications Indications Indications Indications
First-line treatment
of metastatic NSCLC
with EGFR exon 19
deletions or L858R
mutations
Gefitinib Erlotinib Dacomitinib Osimertinib
First-Generation
Reversible EGFR TKIs
Second-Generation
Irreversible EGFR TKIs
Third-Generation
Irreversible EGFR TKI
Afatinib
EGFRmut binding +++
EGFRwt binding +
T790M binding -
CharacteristicsCharacteristicsCharacteristics
EGFRmut binding
EGFRwt binding ++
T790M binding -
EGFRmut binding
EGFRwt binding -
T790M binding
First-line treatment
of metastatic NSCLC
with EGFR exon 19
deletions or L858R,
S768I, L861Q, and/or
G719X mutations
First-line treatment
of metastatic NSCLC
with EGFR exon 19
deletions or L858R
mutations
• First-line treatment of metastatic NSCLC with
EGFR exon 19 deletions or L858R mutations
• Treatment of metastatic EGFR T790M
mutation-positive NSCLC with progression
on or after EGFR TKI therapy
+++ +++
+++

2. PRACTICE AID
Current Recommendations for Molecular Testing
in Advanced EGFR Mutation-Positive NSCLC
1. Lindeman NI et al. J Mol Diagn. 2018;20:129-159. 2. Kalemkerian JP et al. J Clin Oncol. 2018;36:911-919. 3. www.mycancergenome.com. Accessed January 4, 2019.
Access the activity, “Molecular Testing for EGFR Mutations in the Context of a Changing Treatment
Landscape, Evolving Testing Options, and New Guidelines: What Pathologists Need to Know and Do,”
at www.peerview.com/DZD40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Molecular Testing in NSCLC: When, What, and How1,2
Minimum Testing Requirements for EGFR Mutations3
Legend: EGFR TKI FDA Approvals by EGFR Mutation Subtypes
G719X (2%-3%)
Afatinib is approved to treat Osimertinib is approved to treat Afatinib, gefitinib, erlotinib, dacomitinib,
and osimertinib are all approved to treat
No approved treatments;
resistant to EGFR TKIs
Exon 19 deletions/insertions (~49%)
Exon 20 insertion (4%-9.2%)
T790M (<5% in untreated patients/
50% in patients treated with first-
and second-generation EGFR TKIs)
L858R
(43%)
S768I
(1.5%-3%)
L861Q
(2%)
Exon 18 Exon 19 Exon 20 Exon 21
• Circulating cell-free plasma if limited tissue
• Not for primary diagnosis
• Test tissue if negative result
• Guidelines for
EGFR testing
• Histology
• Cytology
– Cell block
– Other preparations
Advanced-stage
lung adenocarcinoma EGFR
ALK
ROS1
(BRAF) EGFR PCR-based
Detect ≥20% T790M PCR-based
Detect ≥5%