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2024 World Conference on Lung Cancer (WCLC) - Post ...
P1.12A.12 Liquid Biopsy Based Risk Stratification ...
P1.12A.12 Liquid Biopsy Based Risk Stratification and Intensification of Treatment in EGFR Mutant Advanced NSCLC (L-BRITE) Preliminary Analysis
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The preliminary analysis of the L-BRITE study investigates a liquid biopsy-based approach to risk stratification and treatment intensification in patients with advanced non-small cell lung cancer (NSCLC) possessing an EGFR mutation. Led by Hemavathi Baskarane at AIIMS, New Delhi, the study focuses on the clearance of circulating tumor DNA (ctDNA) as a potential indicator of progression-free survival (PFS) following targeted therapy. Specifically, the research evaluates whether adding chemotherapy to treatment regimens can improve outcomes in patients with residual ctDNA after initial gefitinib therapy.<br /><br />The study presents a Phase II, single-center, single-arm, open-label design using a Simon 2 Stage approach. It involves 69 plasma ctDNA positive, treatment-naïve metastatic EGFR-mutated patients, who initially receive gefitinib for 9-11 weeks. Those remaining ctDNA positive undergo treatment intensification with chemotherapy. Of these, 25 patients completed four cycles, with notable response outcomes: 13 partial responses, 12 stability, and 1 progressive disease. <br /><br />Grade 3 adverse events were observed during initial chemotherapy cycles. Besides these, the demographic data reveal a median patient age of 52, with a male majority (53.6%). Most patients exhibited mutations in EGFR exon 19 (75.3%), and nearly a third had brain metastases at baseline.<br /><br />Key findings suggest that ctDNA clearance correlates with improved 6-month PFS rates, recorded at 91% for ctDNA negative patients and 84% for those who became negative after chemotherapy. The study marks the first to propose a feasible risk-adapted strategy, underlining the need for further Phase III trials to validate the clinical utility relative to standard combination therapies in all patients with EGFR mutant advanced NSCLC. Active enrollment for the study continues, signaling a focus on subsequent research insights.
Asset Subtitle
Hemavathi baskarane
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Speaker
Hemavathi baskarane
Topic
Metastatic NSCLC – Targeted Therapy
Keywords
L-BRITE study
liquid biopsy
non-small cell lung cancer
EGFR mutation
circulating tumor DNA
progression-free survival
gefitinib therapy
treatment intensification
Phase II trial
risk stratification
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