ASCO: NSCLC Tumor Profiling and Biomarker-Guided Therapy Are Feasible

CHICAGO-A massive French database study shows that genetic tumor profiling in patients with non–small-cell lung cancer (NSCLC) is feasible, and is already helping physicians guide treatment in many patients, according to results presented at the American Society of Clinical Oncology annual meeting.

Analysis of the Biomarker France project was presented by Fabrice Barlesi, MD, PhD, of Aix-Marseille University. The project so far includes six markers: EGFR, KRAS, ALK, BRAF, HER2, and PI3K. The results were based on the first 10,000 patients included in the database, with 9,911 total samples included; 12 were excluded because another kind of solid tumor was found, and researchers were unable to identify the patient in 77 cases.

The included patients were 64% male and had an average age of 64.5 years; 38.1% were current smokers, 44.2% were former smokers, and 17.7% had never smoked. More than 70% had an ECOG performance status of 0 or 1. “In approximately 46% of the cases, a molecular alteration was seen,” Dr. Barlesi said.

The most common such alteration was KRAS mutation, in 27% of patients. EGFR activating mutation was seen in 9.5%, 0.8% had EGFR-resistant mutation, 0.9% had a HER2 mutation, 1.7% had BRAF mutation, 2.6% had PI3K mutation, and ALK rearrangement was seen in 3.7% of patients.

Dr. Barlesi said there was a large difference seen between those who were current or former smokers and those who had never smoked, as would be expected. Never-smokers had some alteration 65% of the time vs 45% of smokers; KRAS mutation was most common in smokers (31.7%) whereas EGFR activating mutation was seen most often in never-smokers (33.2%).

Notably, physicians used the results of tumor profiling to guide their first-line treatment decisions in 57% of evaluable cases. For example, in the 1,006 EGFR-mutated patients, 55.9% received an EGFR-targeted tyrosine kinase inhibitor. Among the 141 ALK-translocated patients, 69.8% received chemotherapy with pemetrexed as first-line treatment.

Dr. Barlesi said that the median overall survival was 11.4 months, but that this was “very preliminary” data in only 2,250 evaluable patients. “The database is continuing to grow, and the final cohort will contain around 19,000 biomarker analyses,” he said. “This study shows that NSCLC tumor profiling is feasible.”

Lecia V. Sequist, MD, MPH, was the discussant for the session and added that newer biomarkers should be added to the database as it grows; she cited ROS1 in particular given recent research on that marker. Furthermore, Dr. Sequist noted that “genotyping needs to go hand in hand with efforts to increase availability to clinical trials.”