ASCO Endorses CAP/IASLC/AMP Guidelines for Molecular Testing of Patients With Non–Small Cell Lung Cancer

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Fred R. Hirsch, MD, PhD

With the endorsement by ASCO, it is our hope that the current guidelines can achieve greater outreach and penetration, particularly in the community practices, where the bulk of lung cancer patients are being treated.

—Fred R. Hirsch, MD, PhD

Personalized medicine is an established treatment concept for patients with advanced non–small cell lung cancer (NSCLC), and molecular characterization of tumors is crucial for choice of (first-line) therapy. As of right now, we have U.S. Food and Drug Administration (FDA)-approved drugs for two molecular targets in the treatment of NSCLC—EGFR mutations and ALK gene rearrangement. However, many questions are raised related to whom should be tested, how to test, which diagnostic assay to use, and what is the optimal tissue source.

All these questions led the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) to join efforts and develop guidelines for “Molecular Testing of Patients With Lung Cancer.” The guidelines have become a role model for similar guidelines in both Europe and Asia.

Implementation of routine molecular testing of the many lung cancer patients throughout the country requires quite a bit of educational effort. The endorsement of these guidelines by ASCO—reported by Leighl and colleagues in the Journal of Clinical Oncology1 and reviewed in this issue of The ASCO Post—is a huge step forward to ensure that all patients with advanced lung cancer (about 180,000 yearly in the United States) will be treated appropriately and managed in the same way, whether their diagnostic workup and treatment are performed in a community setting or in an academic setting.

A Welcome Endorsement

The IASLC and ASCO share the same goal—giving lung cancer patients optimal treatment and care. As CEO of IASLC, I welcome this endorsement, which facilitates our efforts to bring the most updated knowledge to the doctors and other health-care personnel involved in treating lung cancer patients, and to the patients themselves as a means of ensuring that we achieve this goal. It is of utmost importance that the right therapy is given to the right patients; no patient should receive “suboptimal” treatment due to lack of guidelines.

Fortunately, the therapeutic landscape for patients with advanced NSCLC, after decades with a very poor prognosis, has changed dramatically over the past few years due to the availability of targeted therapies for molecularly defined subgroups of patients. Such therapies have led to significantly improved outcomes compared to standard chemotherapy, including long-term survival—in some cases, years. With the endorsement by ASCO, it is our hope that the current guidelines can achieve greater outreach and penetration, particularly in the community practices, where the bulk of lung cancer patients are being treated.

Who to Test

An important question remains: Who should be tested? The guidelines provide evidence-based recommendations and, fortunately, the past several years have brought considerable experience and progress in the management of patients with NSCLC.

Based on my own experience from participation in many educational programs, both at academic centers and in community practices, it is a perception among doctors that patients with “poor performance status” (ie, Eastern Cooperative Oncology Group performance status of 2 or 3) should not undergo molecular testing and subsequent targeted therapy, because the evidence of benefit is based on studies of patients with good performance status. However, as reflected in the current guidelines, this perception must be considered a “misperception.”

Despite lack of solid evidence in clinical trials for patients with poor performance status, it is clear that many patients with advanced NSCLC and poor performance status will benefit from targeted therapies and that molecular testing should be performed in these patients in order to offer them specific targeted therapy with much less toxicity compared to conventional chemotherapy.

Guideline Revisions to Come

With rapid development in the therapeutic landscape for patients with NSCLC, including identification of new “druggable” molecular targets, development of many new drugs, and development of rapid assays, it is expected that the current guidelines will need a revision within 1 to 2 years—an eventuality for which the different organizations involved in guideline development are already preparing. In the meantime, it is important that the current guidelines are adopted as quickly and broadly as possible to ensure that optimal therapy is offered to the many patients with advanced NSCLC.

“No patients left behind” is a relevant motto and goal these days for our patients, whose life perspective has changed dramatically over the past few years. ■

Disclosure: Dr. Hirsch is the CEO of IASLC.


1. Leighl NB, Rekhtman N, Biermann WA, et al: 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 Association for the Study of Lung Cancer/Association for Molecular Pathology guideline. J Clin Oncol. October 13, 2014 (early release online).