Guideline recommendations issued for molecular testing, targeted therapies in lung cancer

The College of American Pathologists (CAP),International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) recently issued evidence-based guidelines on molecular testing in lung cancer, and support the recommendation that physicians conduct testing in advanced non-small cell lung cancer patients at the time of diagnosis or at the time of recurrence or progression.

The guideline recommendations were released April 3, 2013, in Archives of Pathology & Laboratory Medicine, Journal of Thoracic Oncology, and The Journal of Molecular Diagnostics.

“The key recommendation of the guideline, and perhaps most important to lung cancer patients, is that all patients with advanced lung adenocarcinoma should be tested for EGFR and ALK abnormalities, that would qualify them for tyrosine kinase inhibitor therapy, regardless of their clinical variables, such as smoking history, gender, or ethnicity,” IASLC member Marc Ladanyi, MD, attending pathologist in the Molecular Diagnostics Service at Memorial Sloan-Kettering Cancer Center in New York, said in a press release.

Similar to the testing done in breast cancer, matching a cancer patient’s molecular profile with the appropriate targeted therapy provides individualized treatment options.

 A few other key findings in the guidelines include:

• Clinical characteristics (ie, age, gender, ethnicity, smoking history) should not be used as selection criteria for testing on patients with adenocarcinoma; significant numbers of patients who might benefit from targeted therapy may be inappropriately excluded.

• Patients with stage IV disease should be tested at time of diagnosis, or at time of recurrence of progression in patients who originally presented with lower stage disease but were not previously tested.

• Testing for ALK and EGFR at diagnosis in patients with stage I, II or III is encouraged.

• ALK and EGFR testing should be prioritized over other biomarkers.

• ALK testing is recommended for adenocarcinomas and mixed lung cancers with an adenocarcinoma component, regardless of histologic grade.

• Patients presenting with 2 separate primary tumors may have both tumors tested.

• ALK and EGFR molecular testing results should be available within 2 weeks (10 working days).

“Lung cancer used to be treated with a ‘one-size-fits-all’ approach,” Pfizer senior medical director, Xalkori (crizotinib) Lee James, MD, PhD, told Formulary. “Testing a cancer tumor for molecular biomarkers is now becoming a standard approach to cancer diagnosis and provides information about the genetic makeup of a tumor to help oncologists and pathologists classify the specific type of cancer according to the test results. This can help guide physicians to choose an appropriate therapy for each individual, which may include a biomarker-based therapy, aide in the selection of clinical trials, and guide development of molecular-targeted therapies.

“This type of molecular testing is already routine practice in breast and colorectal cancer, and is becoming increasingly important for patients with lung cancer,” Dr James continued. “Pfizer believes these new guidelines will serve as a helpful resource to the lung cancer community by reinforcing the importance of routine molecular testing as part of the lung cancer treatment paradigm.”

According to the American Cancer Society, lung cancer is the second most common cancer in both men and women and the leading cause of cancer death. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. From an economic perspective, lung cancer is among the top 3 cancers causing an impact globally (approximately $188 billion).

“With the advent of personalized medicine, biomarker- based therapies for specific patient populations are now available for some cancers. As a result, unnecessary costs for patients and payers may be avoided since biomarker-based therapies will be prescribed only to a select patient population more likely to respond to treatment,” said Dr James.