Download Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell
Lung Cancer (NSCLC)
HISTOPLUSSM: LUNG CANCER ASSAY
HistoPlusSM: Lung Cancer Assay
An increasing number of clinical studies have shown the importance of establishing the histologic subtype of non-small cell
lung cancer (NSCLC) to guide the use of appropriate subtype-specific therapies for patients.

Patients with tumors classified as squamous cell carcinoma may have adverse effects from treatment with bevacizumab
or pemetrexed.1
 The
NCCN® Guidelines include additional molecular tests (EGFR mutation analysis, ALK gene rearrangements, ROS1 gene
rearrangements) for selecting specific targeted therapies (erlotinib, crizotinib) for tumors classified as adenocarcinoma.2
What is HistoPlusSM: Lung Cancer Assay?

HistoPlus: Lung Cancer assay is a gene expression assay using quantitative real-time PCR (qRT-PCR) for 57 genes expressed
in NSCLC subtypes. This test can be used to distinguish adenocarcinoma from squamous cell cancer subtypes.
 An
interobserver reproducibility study for NSCLC diagnosis found that there was only moderate agreement (kappa
value = 0.55) among pathologists in standard H&E diagnosis of squamous cell carcinoma versus adenocarcinoma.
Higher agreement was associated with differentiated tumors and pathology experience and expertise.3

In an internal comparative study of HistoPlus: Lung Cancer assay results versus standard H&E morphologic classification
(performed at a CLIA certified reference laboratory), an agreement of 90.5% was observed between a consensus
pathology diagnosis and subtype determination by gene expression, in differentiating squamous cell carcinoma from
adenocarcinoma.4
Clinical Dilemma

In current practice many lung tumor samples submitted for pathology evaluation are too small for ancillary IHC testing to
determine the NSCLC subtypes.

Standard morphologic classification (H&E) can produce disagreement between pathologists in providing a specific
diagnosis of adenocarcinoma versus squamous cell carcinoma as determined in the VOILA study.3

Per the NCCN® guidelines, it is important to maintain adequate tissue for molecular testing. Therefore, pathology evaluation
should limit the use of IHC studies in small tissue samples to preserve critical tissue.2
Clinical Application of HistoPlusSM: Lung Cancer Assay
What can be done with problematic cases that cannot be
histologically evaluated by standard H&E, with limited tissue to test
by IHC, or samples with low tumor content?

HistoPlus: Lung Cancer assay is a molecular test that aids
in differentiating squamous cell carcinoma from adenocarcinoma
in NSCLC.5,6

HistoPlus: Lung Cancer assay, in conjunction with morphological
studies, helps further stratify neuroendocrine pulmonary
neoplasms.6

HistoPlus: Lung Cancer assay complements standard
histopathology and can be particularly useful in poorly
differentiated tumors or tumors with limited cellularity.
Methodology
Quantitative real-time PCR (qRT-PCR)
Specimen Requirement Options

Formalin-fixed, paraffin-embedded tissue block (preferred) or

Four unstained slides at 10 μM and one matching H&E slide (Air dry. Do not oven dry.)
CPT Code(s): 81479
REFERENCES
1. Cagle, PT, and Dacic, S, Lung Cancer and the Future of Pathology. Arch Pathol Lab Med 2011; 135:293-5.
2. The NCCN Non-Small Cell Lung Cancer Clinical Practice Guidelines in Oncology (Version 2.2013). ©National Comprehensive Cancer Network, Inc. 2013.
3.Grilley-Olson, J, et al., Validation of Interobserver Agreement in Lung Cancer Assessment Hematoxylin-Eosin Diagnostic Reproducibility for Non-Small Cell
Lung Cancer – The 2004 World Health Organization Classification and Therapeutically Relevant Subsets. Arch Pathol Lab Med 2013; 137:32-40.
4. Data sourced from studies at LabCorp’s Center for Molecular Biology and Pathology.
5. Wilkerson, MD, et al., Prediction of Lung Cancer Histological Types by RT-qPCR Gene Expression in FFPE Specimens. J Mol Diagn 2013; 15:485-97.
6.Miglarese, MR, et al., Evaluation of a Lung Cancer RNA Expression Subtyping Panel and Comparison with Histologic Diagnosis in Lung Tumor Samples
from Multiple Data Sets Including The Cancer Genome Atlas (TCGA). J Clin Oncol 32:5s, 2014 (suppl; abstr 7566).
HistoPlusSM is a service mark of Laboratory Corporation of America® Holdings.
NCCN Guidelines® is a registered trademark of National Comprehensive Cancer Network, Inc.
©2014 Laboratory Corporation of America® Holdings. All rights reserved.
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