LungBEAM: A prospective multicenter study to monitor stage IV NSCLC patients with EGFR mutations using BEAMing technology
Por:
Garrido, P, Paz-Ares, L, Majem, M, Moran, T, Trigo, JM, Bosch-Barrera, J, Garcia-Campelo, R, Gonzalez-Larriba, JL, Sanchez-Torres, JM, Isla, D, Vinolas, N, Camps, C, Insa, A, Juan, O, Massuti, B, Paredes, A, Artal, A, Lopez-Brea, M, Palacios, J and Felip, E
Publicada:
1 sep 2021
Ahead of Print:
1 jul 2021
Resumen:
Objectives The aim of LungBEAM was to determine the value of a novel epidermal growth factor receptor (EGFR) mutation test in blood based on BEAMing technology to predict disease progression in advanced non-small cell lung cancer (NSCLC) patients treated with first- or second-generation EGFR-tyrosine kinase inhibitors (EGFR-TKIs). Another goal was to monitor the dynamics of EGFR mutations, as well as to track EGFR exon 20 p.T790M (p.T790M) resistance during treatment, as critical indicators of therapeutic efficacy and patient survival. Methods Stage IV NSCLC patients with locally confirmed EGFR-TKI sensitizing mutations (ex19del and/or L858R) in biopsy tissue who were candidates to receive first- or second-generation EGFR-TKI as first-line therapy were included. Plasma samples were obtained at baseline and every 4 weeks during treatment until a progression-free survival (PFS) event or until study completion (72-week follow-up). The mutant allele fraction (MAF) was determined for each identified mutation using BEAMing. Results A total of 68 of the 110 (61.8%) patients experienced a PFS event. Twenty-six patients (23.6%) presented with an emergent p.T790M mutation in plasma at some point during follow-up, preceding radiologic progression with a median of 76 (interquartile ratio: 54-111) days. Disease progression correlated with the appearance of p.T790M in plasma with a hazard ratio (HR) of 1.94 (95% confidence interval [CI], 1.48-2.54; p < 0.001). The HR for progression in patients showing increasing plasma sensitizing mutation levels (positive MAF slope) versus patients showing either decreasing or unchanged plasma mutation levels (negative or null MAF slopes) was 3.85 (95% CI, 2.01-7.36; p < 0.001). Conclusion Detection and quantification of EGFR mutations in circulating tumor DNA using the highly sensitive BEAMing method should greatly assist in optimizing treatment decisions for advanced NSCLC patients.
Filiaciones:
Garrido, P:
Univ Alcala De Henares, IRYCIS Hosp Univ Ramon & Cajal, Med Oncol Dept, Madrid, Spain
CIBERONC, Madrid, Spain
Paz-Ares, L:
CIBERONC, Madrid, Spain
Hosp Univ 12 Octubre, Med Oncol Dept, Madrid, Spain
I 12 Res Inst, Madrid, Spain
Spanish Natl Canc Res Ctr CNIO, Lung Canc Grp, Clin Res Program, Madrid, Spain
Univ Complutense Madrid, Madrid, Spain
Majem, M:
Hosp Santa Creu & Sant Pau, Dept Med Oncol, Barcelona, Spain
:
Spanish Lung Canc Grp GECP, Barcelona, Spain
ICO Badalona, Hosp Germans Trias & Pujol, Badalona, Spain
Trigo, JM:
Hosp Univ Virgen Victoria, Dept Med Oncol, Malaga, Spain
Bosch-Barrera, J:
Dr Josep Trueta Hosp Girona, Catalan Inst Oncol ICO, Med Oncol, Girona, Spain
Garcia-Campelo, R:
Hosp Univ Coruna, Dept Med Oncol, La Coruna, Spain
Gonzalez-Larriba, JL:
Hosp Univ Clin San Carlos, Dept Med Oncol, Madrid, Spain
Sanchez-Torres, JM:
Hosp Princesa, Dept Med Oncol, Madrid, Spain
Isla, D:
Hosp Univ Lozano Blesa, Dept Med Oncol, Zaragoza, Spain
Vinolas, N:
Hosp Clin Barcelona, Dept Med Oncol, Barcelona, Spain
Camps, C:
CIBERONC, Madrid, Spain
Univ Valencia, Hosp Gen Univ Valencia, Dept Med Oncol, Valencia, Spain
Insa, A:
Hosp Clin Univ, Dept Med Oncol, Valencia, Spain
Juan, O:
Hosp Univ La Fe, Dept Med Oncol, Valencia, Spain
Massuti, B:
Hosp Gen Univ Alicante, Dept Med Oncol, Alicante, Spain
Paredes, A:
Hosp Univ Donostia, Dept Med Oncol, Donostia San Sebastian, Spain
Artal, A:
Hosp Univ Miguel Servet, Med Oncol, Zaragoza, Spain
Lopez-Brea, M:
Hosp Univ Marques Valdecilla, Dept Med Oncol, Santander, Spain
Palacios, J:
CIBERONC, Madrid, Spain
Univ Alcala De Henares, IRYCIS Hosp Univ Ramon & Cajal, Dept Pathol, Madrid, Spain
Felip, E:
Hosp Univ Valld Hebron, Dept Med Oncol, Barcelona, Spain
gold, Green Published
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