American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small Cell Lung Cancer Considering First-Line EGFR Tyrosine-Kinase Inhibitor (TKI) Therapy

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American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small Cell Lung Cancer Considering First-Line EGFR Tyrosine-Kinase Inhibitor (TKI) Therapy

Published in the Journal of Clinical Oncology vol. 29, issue 15 (May 20), 2011: pp. 2121-2127

Vicki Leigh Keedy, Sarah Temin, Mark R. Somerfield, Mary Beth Beasley, David H. Johnson, Lisa M. McShane, Daniel T. Milton, John R. Strawn, Heather A. Wakelee, Giuseppe Giaccone

Important note: This Provisional Clinical Opinion reflects a change in Recommendation D1 (on molecular testing) in the ASCO Clinical Practice Guideline Update on Chemotherapy for Stage IV Non–Small-Cell Lung Cancer and will be incorporated in that guideline when it is next updated.

Purpose: An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO’s membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the clinical utility of using epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non–small-cell lung cancer (NSCLC) to predict the benefit of taking a first-line EGFR tyrosine kinase inhibitor (TKI).

Clinical Context: Patients with EGFR-mutated NSCLC have a significantly higher rate of partial responses to the EGFR TKIs gefitinib and erlotinib. In the United States, approximately 15% of patients with adenocarcinoma of the lung harbor activating EGFR mutations. EGFR mutation testing is widespread at academic medical centers and in some locales in community practice. As of yet,
there is no evidence of an overall survival (OS) benefit from selecting treatment based on
performing this testing.

Recent Data: One large phase III trial (the Iressa Pan-Asia Study [IPASS] trial), three smaller phase III randomized controlled trials using progression-free survival as the primary end point, and one small phase III trial with OS as the primary end point, all involving first-line EGFR TKIs and chemotherapy doublets, form the basis of this PCO.

Provisional Clinical Opinion: On the basis of the results of five phase III randomized controlled trials, patients with NSCLC who are being considered for first-line therapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy.

To discuss this guideline, visit the ASCOconnection.org Practice forum. Log in with your asco.org username and password to comment.

The Provisional Clinical Opinion (PCO) is not intended to substitute for the independent professional judgment of the treating physician. Practice guidelines and PCOs do not account for individual variation among patients and may not reflect the most recent evidence. The PCO does not recommend any particular product or course of medical treatment. Use of the PCO is voluntary.

Last Updated: 4/20/11