Guidelines for Molecular Testing for Lung Cancers
Lawyers litigating lung cancer cases will need increasing knowledge of mutations related to lung cancer, and their implications as to causation and treatment. Various professional medical groups issued April 2013 guidelines for molecular testing and targeted therapies for lung cancer. The guidelines are online and free at this page. The press release is online and pasted below:
Advances in Molecular Testing Offer New Hope for Lung Cancer Patients
Leading Health Care Organizations Issue Guideline Recommendations for Molecular Testing and Targeted Therapies
NORTHFIELD, ILL.— The emergence of molecular diagnostic testing in lung cancer offers new hope for
patients battling the number one cancer killer in the United States and abroad. Now, for the first time after a decade of biomarker testing in lung cancer, a uniform approach for testing for the EGFR mutation and ALK rearrangement along with the availability of targeted therapies offer lung cancer patients the chance for improved quality of life and more time with their loved ones.
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer
(IASLC), and the Association for Molecular Pathology (AMP) have developed an evidence-based
guideline, “Molecular Testing Guideline for the Selection of Lung Cancer Patients for EGFR and ALK
Tyrosine Kinase Inhibitors,” which establishes recommendations for EGFR and ALK testing, helping to
guide targeted therapies. The guideline was released on April 3, 2013, in Archives of Pathology &
Laboratory Medicine (APLM), 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,” said Marc Ladanyi, MD, attending pathologist in the Molecular
Diagnostics Service at Memorial Sloan-Kettering Cancer Center in New York, and IASLC member.
Similar to the testing done in breast cancer, matching a cancer patient’s molecular profile with the
appropriate targeted therapy provides individualized treatment options. The guideline answers important
clinical questions, including:
o When should testing be performed?
o How should testing be performed?
o Should other genes be routinely tested in lung cancer?
o How should molecular testing of lung cancer be implemented?
“In the U.S. up to 20 percent of patients with lung adenocarcinoma, the most common type of lung
cancer, will test positive for one of the two biomarkers,” said Philip T. Cagle, MD, FCAP, medical director
of Pulmonary Pathology in the Department of Pathology and Genomic Medicine at The Methodist
Hospital in Houston, Texas, APLM editor, and CAP member. “It is critical to identify these patients
because they stand to benefit more from new targeted drugs than from conventional chemotherapy, and
with fewer side effects.”
For lung cancer survivor Richard Heimler, molecular diagnostic testing has meant five additional years
with his family, including his daughter and son. After his initial diagnosis in 2004, Heimler had surgery to
remove cancer tumors in his lungs and brain. When multiple tumors returned in 2008, Heimler
participated in a clinical trial to determine if he was a candidate for targeted therapies.
“After testing positive for the abnormal ALK gene, I began taking a targeted drug in the form of a pill,” said Heimler. “It was wonderful to not experience the debilitating side effects that I had with chemotherapy. This new world of science has given me hope that I will have more time to create memories with my children and watch them grow up.”
In an era of precision medicine, the guideline provides recommendations for pathologists, oncologists,
and other cancer health professionals on the current state-of-the-art recommendations for the molecular
testing of lung cancer.
“The three organizations came together to address the variance in practice around the world about how
this testing should performed,” said Neal I. Lindeman, MD, director of Molecular Diagnostics at Brigham
and Women’s Hospital and associate professor of Pathology at Harvard Medical School in Boston, and
AMP member. “Pathologists who specialize in molecular diagnostics and lung cancer collaborated to
create the guideline to minimize variation and provide greater precision in the care of patients.”
The CAP Pathology & Laboratory Quality Center, (the Center,) a forum for developing evidence-based
guidelines and consensus recommendations, provided the process for creating the guideline. Expert
panels made up of renowned worldwide leaders in the field collaborated to develop the
“The guideline is an important step in making sure that patients benefit from the new molecular
understanding of lung cancer,” said Dr. Ladanyi. “As new studies lead to further evidence-based
recommendations, we hope to develop additional guidelines for other biomarkers related to this disease.”
In conjunction with the publishing of the guideline, CAP, IASLC, and AMP have developed clinical tools
and resources for pathologists and oncologists that summarize the findings and recommendations. In
addition, the organizations have developed a patient guide for further understanding, including questions
for patients to ask their physicians. A series of videos featuring three of the guideline authors and a lung
cancer survivor can be found on the CAP, IASLC, and AMP YouTube Channels.