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EGFR expression identified greatest cetuximab benefit in patients with NSCLC
Pirker R. Lancet Oncol. 2011;doi:10.1016/S1470-2045(11)70318-7.
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Increased epidermal growth factor receptor expression in patients with advanced non–small cell lung cancer predicted which patients had the greatest survival benefit when treated with cetuximab and first-line chemotherapy, results of a substudy indicate.
The substudy was part of the FLEX study, which compared the use of chemotherapy alone vs. chemotherapy plus cetuximab (Erbitux, Merck) — an EGFR inhibitor — in the treatment of advanced NSCLC.
Data from the initial analysis indicated adding cetuximab improved OS compared with chemotherapy alone.
However, researchers wanted to further define which patients would have the most benefit derived from adding this targeted agent to their treatment regimen.
They collected tumor EGFR expression data from 1,121 of 1,125 patients. They then used a scoring system to identify those patients with low EGFR expression (69%) or high EGFR expression (31%).
Results indicated that, in those patients with high EGFR expression, OS was longer when treated with combination therapy compared with chemotherapy alone (12 months vs. 9.6 months; P=.01).
At 1 year, the median survival for patients with high expression on combination therapy was 50% vs. 37% for chemotherapy alone.
By year 2, 24% of those on combination therapy were alive vs. 15% of those on chemotherapy alone.
In the low EGFR expression group, researchers found no significant difference between treatment with chemotherapy plus cetuximab compared with chemotherapy alone.
An OS benefit in the high EGFR expression group was noted in all major NSCLC histological subgroups assessed, including the two most common, squamous cell carcinoma and adenocarcinoma.
Patients in both groups had similar adverse effects, and they were similar to those reported in the safety profile of the drugs.
“We believe that this improved benefit-risk ratio will result in a change in routine clinical practice in this setting,” the researchers wrote. “To our knowledge, EGFR expression level is the first biomarker shown to be associated with survival benefit for a targeted therapy added to first-line chemotherapy in patients with advanced NSCLC.”
In an editorial that accompanied the article, Fred R. Hirsch, MD, PhD, professor of medicine and pathology at the University of Colorado Cancer Center in Aurora, Colo., and Roy Herbst, MD, chief of medical oncology at Yale Comprehensive Cancer Center in New Haven, Conn., wrote: “Clearly the use of targeted drugs requires specific criteria for patient selection based on the assessment of a molecular target … Use of EGFR immunohistochemistry in the FLEX study seems to be an encouraging step towards personalized medicine for patient subgroups with advanced lung cancer who will potentially receive cetuximab.”
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