Targeted tyrosine kinase inhibitors (TKIs) have revolutionized treatment for patients with lung cancer, particularly in those who have epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) gene rearrangements.

However, TKIs are effective only for patients with these specific biomarkers, making their identification crucial to appropriate care. Consensus guidelines for molecular testing of lung cancer, developed by a multidisciplinary group of pathologists and lung cancer specialists, were released in February 2013 with the goal of systematizing clinical practice to optimize treatment decision making (See “New Consensus on Approach to Molecular Testing in Lung Cancer”).1 However, two new surveys demonstrate gaps in knowledge of molecular testing that may undermine its recommended use.

The surveys were conducted online by Harris Interactive and designed by Boehringer Ingelheim Pharmaceuticals as a follow-up to a 2011 survey of patients with lung cancer. In the 2011 survey, oncologists, and oncology nurses that indicated a need for greater communication about biomarker testing between clinicians and patients.

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In the follow-up survey, pathologists and pulmonologists in the United States were asked about their use of and concerns with molecular testing for patients with lung cancer. While there were some differences in knowledge and attitudes about testing between the groups, the findings overall revealed gaps with the potential to impact care.

Only 43% of pulmonologists and 33% of pathologists said biomarker testing at lung cancer diagnosis was a part of their current practice. Forty-one percent of the pulmonologists felt they needed more information about the necessary sample size for molecular testing. Obtaining tissue samples of sufficient quality and quantity was also an issue. Approximately two thirds of pathologists (73%) and pulmonologists (60%) cited the acquisition of an adequate amount of tissue as their major obstacle to molecular testing. Acquiring the necessary quality tissue was cited as an obstacle by 31% of pulmonologists and 39% of pathologists.

The groups also differed in their beliefs about which sampling techniques were optimal (Table 1). A positive finding was that more than half of clinicians in each group said that over the past 5 years their participation in a multidisciplinary approach to care has increased.

Table 1: Sampling Technique Considered to Achieve Best Balance of Quantity/Quality and Risk to Patient 

Endoscopic biopsy 51% 15%
Fine needle aspiration 33% 10%
Core biopsy 44% 63%

In general, these new surveys highlight a lack of consistent knowledge about methods for proper tissue acquisition. The new consensus guidelines were created to address just such gaps in knowledge and practice. Acknowledging the clinical importance of biomarker testing in identifying patients who can benefit from targeted therapy, EGFR and ALK testing at diagnosis is recommended for all patients diagnosed with lung adenocarcinoma or mixed tumor with adenocarcinoma components and who are candidates for TKI therapy.1

To address the types of obstacles raised in these surveys, the recommendations also include detailed guidance on prioritizing tissue samples for EGFR and ALK testing, the types of tests to use, sample preparation and preservation, and testing priorities. The gaps in knowledge revealed in these surveys again underscore the importance of raising awareness of consensus guidelines and recommendations among practicing clinicians.


1. Lindeman NI, Cagle PT, Beasley MB, et al. Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors. Guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Mol Med. 2013; doi: 10.5858/arpa-2012-0720-OA.