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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2830 - LungBEAM: A prospective multicenter trial to monitor EGFR mutations using BEAMing technology in Stage IV NSCLC patients

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Pilar Garrido Lopez

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

P. Garrido Lopez1, E. Felip2, L. Paz-Ares3, M. Majem4, T. Moran5, J.L. Gonzalez-Larriba6, J. Bosch Barrera7, J.M. Trigo Perez8, M.R. Garcia Campelo9, J.M. Sanchez Torres10, D. Isla11, N. Vinolas Segarra12, C. Camps13, A. Insa Molla14, O.J. Juan Vidal15, B. Massutí16, A. Paredes Lario17, A. Artal-Cortes18, M. Lopez-Brea Piqueras19, J. Palacios Calvo20

Author affiliations

  • 1 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 2 Medical Oncology Service (lung Cancer Unit)  , Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 3 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 4 Medical Oncology Services, Hospital De La Santa Creu I Sant Pau, Barcelona/ES
  • 5 Medical Oncology, ICO Badalona, 08912 - Badalona/ES
  • 6 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 7 Medical Oncology, Catalan Institute of Oncology (ICO)-Hospital Universitari Josep Trueta, 17007 - Girona/ES
  • 8 Medical Oncology, Hospital Universitario Virgen de la Victoria, 29010 - Málaga/ES
  • 9 Medical Oncology, Hospital Universitario a Coruna - a Corunac, 15006 - A Coruna/ES
  • 10 Medical Oncology, Hospital Universitario de La Princesa, 28006 - Madrid/ES
  • 11 Medical Oncology, Hospital Clinico Universitario Lozano Blesa, 50009 - Zaragoza/ES
  • 12 Medical Oncology, Hospital Clinic y Provincial de Barcelona, 8036 - Barcelona/ES
  • 13 Medical Oncology, Consorcio Hospital General Universitario de Valencia, 46014 - Valencia/ES
  • 14 Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 15 Medical Oncology, Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 16 Oncología Médica, Hospital General Universitario Alicante, Alicante/ES
  • 17 Medical Oncology, Hospital Donostia, 20080 - San Sebastian/ES
  • 18 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 19 Medical Oncology, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES
  • 20 Pathology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
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Abstract 2830

Background

Liquid biopsy is a promising approach to improve the management of NSCLC patients, as it offers a minimally-invasive alternative to tumor tissue testing and enables timely monitoring of patients on-therapy. The goal of the present study was to evaluate the clinical value of longitudinal testing of EGFR mutation status in plasma of tissue EGFR mutation-positive NSCLC patients during first-line EGFR TKI therapy across 19 Spanish hospitals to: 1) determine the timing of T790M mutation emergence and 2) monitor EGFR mutation levels in plasma during first-line EGFR TKI therapy with respect to radiological progression.

Methods

Blood samples from 109 therapy-naïve advanced NSCLC patients were collected at baseline and monthly throughout EGFR TKI standard therapy. Results from OncoBEAM EGFR mutation were performed by Sysmex in Hamburg, and compared to those obtained by the EGFR tissue testing obtained at the referring hospital. The times at which T790M were first detected in blood were compared to the date of progression as determined by radiological imaging in standard clinical practice.

Results

At baseline, the initial positive percent agreement (PPA) for EGFR mutation status in 78 out of 109 patients enrolled in this study was 71.6%. From a total of 60 patients out of 89 who completed the study showing either clinical or radiological progression, 20 patients (33.3%) showed presence of the T790M mutation in plasma during follow-up. In 13 of these patients plasma T790M-positivity was detected an average of 14 weeks prior to radiological progression. Furthermore, the clearance of EGFR mutations in plasma at 8 weeks after initiation of EGFR TKI was a favorable indicator for PFS (37.3 weeks with clearance vs 25.5 weeks in patients without clearance). Patients showing EGFR mutation clearance at 8 weeks had an average baseline MAF of 3.6%, whereas patients with detectable mutations at 8 weeks showed an average baseline value of 13% MAF.

Conclusions

Overall, these results show high PPA of plasma and tissue EGFR mutation status at baseline. Early EGFR mutation clearance may be predictive of response to first-line EGFR TKI therapy. Plasma detection of T790M mutation anticipates clinical progression.

Clinical trial identification

SYS-ONC-2015-01.

Legal entity responsible for the study

Sysmex Inostics GmbH.

Funding

Sysmex Inostics GmbH.

Editorial Acknowledgement

Not applicable

Disclosure

All authors have declared no conflicts of interest.

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