Molecular Testing for Selection of Patients With Lung Cancer for Epidermal Growth Factor Receptor and Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Society for the Study of Lung Cancer/Association of Molecular Pathologists Guideline

Molecular Testing for Selection of Patients With Lung Cancer for Epidermal Growth Factor Receptor and Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Society for the Study of Lung Cancer/Association of Molecular Pathologists Guideline

1. Natasha B. Leighl, 
2. Natasha Rekhtman, 
3. William A. Biermann, 
4. James Huang,
5. Mari Mino-Kenudson, 
6. Suresh S. Ramalingam, 
7. Howard West, 
8. Sara Whitlock and
9. Mark R. Somerfield

+Author Affiliations

1. Natasha B. Leighl, Princess Margaret Cancer Centre, Toronto, Ontario, Canada; Natasha Rekhtman and James Huang, Memorial Sloan Kettering Cancer Center, New York, NY; William A. Biermann, Einstein Medical Center Montgomery, East Norriton, PA; Mari Mino-Kenudson, Massachusetts General Hospital and Harvard Medical School, Boston, MA; Suresh S. Ramalingam, Winship Cancer Institute, Emory University, Atlanta, GA; Howard West, Swedish Cancer Institute, Seattle, WA; Sara Whitlock, Free to Breathe, Madison, WI; and Mark R. Somerfield, American Society of Clinical Oncology, Alexandria, VA.

1. Corresponding author: American Society of Clinical Oncology, 2318 Mill Rd, Suite 800, Alexandria, VA 22314; e-mail: guidelines@asco.org.

1. N.B.L. and N.R. contributed equally to this work and are listed in alphabetical order.

Abstract

Purpose The College of American Pathologists (CAP), the International Society for the Study of Lung Cancer (IASLC), and the Association of Molecular Pathologists (AMP) guideline on molecular testing for the selection of patients with lung cancer for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors was considered for endorsement.

Methods American Society of Clinical Oncology (ASCO) staff reviewed the CAP/IASLC/AMP guideline for developmental rigor; an ASCO ad hoc review panel of experts reviewed the guideline content.

Results The ASCO panel concurred that the recommendations are clear, thorough, and based on the most relevant scientific evidence in this content area and present options that will be acceptable to patients. The CAP/IASLC/AMP guideline comprises 37 recommendations (evidence grade A or B), expert consensus opinions, or suggestions that address the following five principal questions: (1) When should molecular testing be performed? (2) How should EGFR testing be performed?(3) How should ALK testing be performed? (4) Should other genes be routinely tested in lung adenocarcinoma? (5) How should molecular testing be implemented and operationalized?

Conclusion The ASCO review panel endorses the CAP/IASLC/AMP guideline. This guideline represents an important advance toward standardization of EGFR and ALKtesting practices and is of major clinical relevance in advancing the care of patients with lung cancer. In the Discussion section, the ASCO review panel highlights three evolving areas: advances in ALK testing methodology, considerations for selecting appropriate populations for molecular testing, and emergence of other targetable molecular alterations.