lung cancer screening

Lung Cancer Biomarkers: Closing the Gap from Discovery to Practice (Part 2)

Read Part 1 here.

Research continues to broaden the spectrum of non-small cell lung cancer (NSCLC) biomarkers.1 Coupled with appropriate targeted therapies, this paves the treatment road with something other than chemotherapy, which has historically poor outcomes.2,3 Because of this progress, mutational analysis is imperative following a lung cancer diagnosis, according to Gerard A. Silvestri, MD, MS, Hillenbrand Professor in Thoracic Oncology at the Medical University of South Carolina in Charleston. But with inconsistent practice patterns, not all patients have access to biomarker testing, negating the potential benefit of their companion therapies for NSCLC, Dr. Silvestri said in a recorded presentation for Olympus on August 2, 2022. 

Overview of clinical guidelines

Dr. Silvestri reviewed the evolving landscape of biomarker research and clinical practice guidelines. In 2013, guidelines were issued based on evidence that ALK and EGFR testing is beneficial to identify patients with these mutations who would benefit from targeted therapy. These guidelines also recommended use of endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) for lymph node staging.4 In 2018, guidelines were updated to include ROS1 testing for all adenocarcinoma patients; in addition to ERBB2, MET, BRAF, KRAS, and RET testing.5 

Dr. Silvestri

Gerard A. Silvestri, MD, MS

A survey of pulmonologists 

But not all practices are on the same page. Dr. Silvestri cited results of a cross-sectional survey published of 453 pulmonologists conducted between April and May 2019 in his August 2, 2022, presentation. Key questions addressed:6

•    Practices for diagnosing advanced lung cancer using EBUS-TBNA
•    Collaboration between subspecialties
•    Knowledge of individual biomarkers

“The first thing you should notice is out in the community, pulmonologists only see about one to four cases of lung cancer a month,” Dr. Silvestri observed.6 “To ask them to remember all the stuff [in the guidelines] about biomarker testing is probably unreasonable.” 

Of those surveyed,
•    51% evaluated one to four cases a month
•    19% evaluated more than 10 cases a month

As one of the researchers, Dr. Silvestri recalled that pulmonologists were asked: “How many passes do [you] make during EBUS?” to collect tissue for biomarker testing. “You need a lot of tissue. Most people send three to four passes, but I can tell you the doctors who [diagnose] a lot of lung cancer send way more than that. They want to make sure they have enough for molecular markers. Fourteen percent of pulmonologists are not sending much of anything,” he said of their findings.6

On the question of who orders molecular testing, Dr. Silvestri broke it down:
•    Oncologists 37%
•    Pathologists 31% 
•    Pulmonologists 23%
•    Tumor Board 7%

“I would argue that it should be a pulmonologist doing a reflex test, otherwise they have to wait for the oncologist because they can’t [start a treatment plan] until they get a biomarker result,” said Dr. Silvestri. Interventional pulmonologists in an academic setting were found to do more testing than community pulmonologists.6

Stump for testing 

“We have to educate our community pulmonologists to make sure they’re testing for all of the available mutations,” said Dr. Silvestri in his August 2, 2022 presentation. He pointed to work being done on several fronts to raise awareness and make testing more mainstream.

The National Lung Cancer Roundtable (NLCRT) spearheaded by the American Cancer Society is composed of more than 200 national and international experts. Dr. Silvestri said the group is working on a strategic plan to advance biomarker testing. A series of papers on the topic is curated on the group’s Promote Guideline-Concordant Lung Cancer Staging page. More papers are in the works on the current state, needs, and barriers to implementing best practices in the lung cancer field. 

“As lung cancer screening rates rise, lung nodule evaluation becomes critically important,” concluded Dr. Silvestri. “We don’t want to miss cancers when they’re present, but also, we don’t want to cause harm to those without cancer.” ”


1.    American Lung Association. Lung Cancer Biomarker Testing. Accessed November 1, 2022.
2.    Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002;346(2):92-98. 
3.    Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26(21):3543-3551. 
4.    Silvestri GA, Gonzalez AV, Jantz MA, et al. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013;143(5 Suppl):e211S–e250S.
5.    Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted 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. J Thorac Oncol. 2018;13(3):323-358. 
6.    Fox AH, Jett JR, Roy UB, et al. Knowledge and practice patterns among pulmonologists for molecular biomarker testing in advanced non-small cell lung cancer. Chest. 2021;160(6):2293-2303.

Dr. Silvestri is a paid consultant of the Olympus Corporation, its subsidiaries and/or its affiliates.

Olympus Corporation of the Americas and its parents, subsidiaries, affiliates, directors, officers, employees, agents, and representatives (collectively “Olympus”) do not represent to or warrant the accuracy, reliability, or applicability of the Case Study.


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