Year: 2010
Type: letter
Abstract: The authors point out that both the FLEX (First-Line Erbitux in Lung Cancer) and the BMS-099 (Bristol-Myers Squibb-099) trials are consistent in showing a small benefit of adding cetuximab to chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC); however, only the FLEX study reached its primary end point of showing a significant improvement in overall survival when cetuximab is added to first-line chemotherapy.We also share their strong concern that a biomarker is needed to select which patients with advanced lung cancer benefit from this treatment approach.There are limitations to biomarker analyses that are based on a small subset of patients.The available samples from any one trial are indeed small and may only permit hypothesis generation.However, if any of the markers had strong enough predictive potential to be useful clinically, it is improbable that no (positive) relationship would be seen in any of the trials (FLEX, BMS-099, and so on).The size of the data set was large enough to show an interaction trend if the predictive effect of a marker were of the same magnitude as the mutation status of the KRAS gene in metastatic colorectal cancer (CRC).Unlike as seen in some of the CRC studies, few (Ͻ 30%) patients with lung cancer have samples available for study, as sample collection is generally optional.The small number of patients in the mutationpositive group is an additional limitation.We would like to point out that EGFR mutation analysis was carried out in 166 patients, not in only 15 patients as stated in the letter.Future NSCLC trials should mandate tissue collection as a condition of study entry.Only with adequate tissue will we be able to discover and validate predictive biomarkers that will optimize patient selection for targeted therapies.
Source: Journal of Clinical Oncology
Authors: Thomas J. Lynch, Shirin Khambata-Ford
Institutions: Yale Cancer Center, Bristol-Myers Squibb (United States)
Language: French
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2088217844