The College of American Pathologists (CAP), the International
Association for the Study of Lung Cancer (IASLC), and the Association
for Molecular Pathology (AMP) are teaming to revise the evidence-based
guideline, “Molecular Testing Guideline for Selection of Lung Cancer
Patients for EGFR and ALK Tyrosine Kinase Inhibitors.”
The updated guideline will include new recommendations for ALK testing
by IHC, ALK-EGFR resistance, and a number of emerging target molecular
targets which will include, but is not limited to, ROS1, MET, ERBB2,
RET, NTRK1. Multiplexed "Next Generation Sequencing" multigene panels
and the reassessment of immunohistochemistry will be reviewed. The role
of rebiopsy and repeat analysis in the setting of post-treatment
relapse, along with testing of blood samples for mutations in
circulating tumor cells, cell free tumor DNA, or exosomes will be
considered.
The revision of the guideline will again be based on evidence from
unbiased review of published experimental literature. The revisions will
be recommended by an expert panel made up of renowned worldwide leaders
in the field. The revision will start in early 2015, taking around 18
months to complete.
The three organizations collaborated in 2013 to develop the original
version of the guideline which addressed which patients and samples
should be tested and when and how testing should be performed.
"Although only one year has passed since the molecular testing guideline
was published, rapid accumulation of scientific knowledge and new
evidence in this field indicate that the guidelines should be updated.
Thus, an update has begun that includes an expanded list of genes and
new methods that are clinically relevant,” said Yasushi Yatabe, MD, PhD,
chief, Department of Pathology and Molecular Diagnostics, Aichi Cancer
Center, Nagoya, Japan and IASLC member.
Patients battling lung cancer in the United States and abroad have
continued hope with the benefits of these guidelines. Testing for the
EGFR mutation and ALK rearrangements and the use of targeted therapies
have given lung cancer patients the chance for survival, along with
improved quality of life and time with loved ones.
“More than 224,200 new cases of lung cancer were diagnosed in 2014 in
the United States,” 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, Archives of Pathology
and Laboratory Medicine editor-in-chief, and CAP member. “Rapid
advancements in genetic testing offer new treatment options for patients
with advanced lung cancer. The updates to the guideline will help
pathologists and oncologists to provide more accurate testing, leading
to more optimal patient care.”
As an active and asymptomatic recently retired, exceedingly proud new
grandmother, Linda Wilkinson was completely taken aback by the diagnosis
of Stage 4 lung cancer. She underwent three rounds of genomic testing
and was identified as having the EML4-ALK translocation in June and has
been on Xalkori since then with visible improvement in the shrinkage of
her primary tumor.
No new metastases have been noted. "I live in gratitude for all the
professionals working in the area of genomic testing and targeted
treatment. Since going on a targeted agent which specifically addresses
my genetic mutation, I have felt renewed hope, energy and enthusiasm for
life. It has lengthened my time horizon immensely and I foresee the day
when these technologies (and new drug developments) make living with
cancer something that can be successfully managed for years and years."
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.
“Molecular testing of the lung cancer patient’s tumor is today crucial
for selection of the most optimal therapy from the treatment start,”
says Professor Fred R. Hirsch, MD, PhD, University of Colorado and CEO
of the International Association for the Study of Lung Cancer (IASLC).
“It is also necessary to address eventual molecular testing of tumors
from patients, who eventually progress on first-line therapy in order to
learn about biological mechanisms for treatment failure and for guiding
subsequent therapy today and in the future,” continues Dr. Hirsch.
“The approach will be similar and will again be based on evidence from
unbiased review of published experimental literature, but will be
accelerated by concentrating on a smaller number of topics,” 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.”
In October of 2014, The American Society of Clinical Oncology (ASCO)
Clinical Practice Guidelines Committee (CPGC) endorsed the CAP/IASLC/AMP
guideline for EGFR and ALK molecular testing. This is significant to the
CAP/ IASLC/AMP guidelines because it reinforces the importance of
molecular testing. The goal is to give providers and patients the best
recommendations to treat their lung cancer
In conjunction with the publishing of the guideline, CAP,
IASLC,
and AMP
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.
About the College of American Pathologists
As the leading organization with more than 18,000 board-certified
pathologists, the College of American Pathologists (CAP) serves
patients, pathologists, and the public by fostering and advocating
excellence in the practice of pathology and laboratory medicine
worldwide. The CAP’s Laboratory Improvement Programs, initiated 65 years
ago, currently has customers in more than 100 countries, accrediting
7,600 laboratories and providing proficiency testing to 20,000
laboratories worldwide. Find more information about the CAP at cap.org.
Follow CAP on Twitter: @pathologists.
About IASLC
The International Association for the Study of Lung Cancer (IASLC) is
the only global organization dedicated to the study of lung cancer.
Founded in 1974, the association’s membership includes nearly 4,000 lung
cancer specialists in 80 countries. IASLC members promote the study of
etiology, epidemiology, prevention, diagnosis, treatment and all other
aspects of lung cancer and thoracic malignancies. IASLC disseminates
information about lung cancer to scientists, members of the medical
community and the public, and uses all available means to eliminate lung
cancer as a health threat for the individual patients and throughout the
world. Membership is open to any physician, scientist, nurse or allied
health professional interested in lung cancer, including patients,
survivors, caregivers and advocates. To learn more about IASLC please
visit http://www.iaslc.org/
About AMP
The Association for Molecular Pathology (AMP) is a not-for-profit
scientific society that advances the clinical practice, science, and
excellence of molecular and genomic laboratory medicine through
education, innovation, and advocacy to enable highest quality health
care. AMP's 2,000+ members are from nearly 50 countries and include
individuals from academic and community medical centers, government, and
industry; including, basic and translational scientists, pathologist and
doctoral scientist laboratory directors, medical technologists, and
trainees. www.amp.org.
Copyright Business Wire 2015