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Oscar Jose Juan Vidal



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      141P - Effect of central nervous system (CNS) metastases in a real-world multicenter cohort study of Spanish ALK-positive non-small cell lung cancer (NSCLC) patients (p) (ID 565)

      12:30 - 13:00  |  Author(s): Oscar Jose Juan Vidal

      • Abstract
      • Slides

      Background

      CNS is a common site of metastases in patients with ALK-positive NSCLC. CNS metastases are associated with a number of deleterious effects, such as reduction in quality of life. However, the relationship between brain metastases and prognosis remains unclear. We aimed to evaluate the effect of CNS metastases on overall survival (OS) in a multicenter cohort of Spanish ALK-positive NSCLC patients diagnosed between 2008 and 2017.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      We included patients with stage IV at diagnoses, followed up to April 2018; OS (months [m]) was estimated with the Kaplan-Meier method. Survival curves were compared between groups of patients using the log-rank test. Hazard risk (HR) to death was estimated with multivariable Cox model.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Out of 163 patients in the cohort, a total of 116 were evaluated, with a median of follow-up of 29.2 m and 59 deaths reported. Characteristics at diagnosis were a median age of 58 years, 50% female, 58.6% never-smokers, 54.3% with comorbidities, PS by ECOG 0-1 93.1%. CNS metastases (median number of lesions 6) were present in 43.1% of patients and 34% of patients with CNS metastases were treated with local therapy (11.8 % local radiotherapy and 76.5% holocraneal radiotherapy). ALK inhibitors as first line and second line treatment were administered to 45.5% and 78.6% of patients, respectively. The median OS was 39 months; OS in patients with CNS metastases at diagnosis was 34.4 m and 39.0 m in those without CNS metastases at diagnosis (p=.9). In patients without CNS metastases at baseline (n=60), 22 developed CNS, with a median OS greater than in those without CNS metastases during follow-up, although the difference is not significant (45.5 m vs 33.3 m; p=.9). There were 81 patients who presented with metastases in more than one organ and 33 patients with metastases in a single organ. The risk of death increased as the number of metastatic organs at diagnoses increased (HR=1.26, p=.0305), with worse OS in those presenting with liver metastases at diagnoses (21.1%, OS: 20 m), compared to those without tumor involvement (OS: 45.4 m; p =.008).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      OS was similar for ALK-positive NSCLC patients with and without CNS metastases at diagnoses. OS was worse as the number of metastatic organs at diagnosis increased, with liver metastases being associated with the highest risk of mortality.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      Catalan Oncology Institute.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      29P - Pretreatment T790M mutation detection by ultrasensitive PCR assay as predictor of efficacy in non-small lung cancer (NSCLC) patients treated with 1<sup>st</sup> or 2<sup>nd</sup> generation EGFR tyrosine kinase inhibitors (TKIs) (ID 477)

      12:30 - 13:00  |  Presenting Author(s): Oscar Jose Juan Vidal

      • Abstract
      • Slides

      Background

      T790M mutation detection previos to 1st/2nd generation EGFR TKIs treatmentis rare by conventional methods (1-8%), although PCR ultrasensitive methods increase their prevalence to 34-80%. The aim of the study is to evaluate the presence of T790M mutations by 2 different ultrasensitive assays and their impact efficacy.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      127 patients (pts) with NSCLC and EGFR mutations were analyzed. 73 of them had sufficient pretreatment tissue for T790M testing. The T790M mutation was screened by PNA Clamp TaqMan Assay (Applied Biosystems) and by ddPCR (BioRad).

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      The limit of detection (LOD) of variant allele frequency was 0.081% and 0.136% for PNA Clamp and ddPCR, respectively. Prevalence of T790M mutations pretreatment was 23% (17/73) and 32% (23/71), respectively. A total of 71 samples gave a certain result in both methodologies (71/73; 95.89%). Agreement between the results of both techniques was 91.55%. Finally, 31 pts who met the eligibility criteria: diagnoses of advanced NSCLC, treated with 1st/2on generation TKIs, have pre-treatment tissue for the analysis and the result of the T790M ultrasensitive analysis was conclusive; were selected to assess the relationship between the results of T790M determined by ultrasensitive methods and the prognosis. Nine (29%) of them had pretreatment T790M+ mutation by both ultrasensitive methods. Median PFS and OS were superior for patients with T790M detected by ultrasensitive PCR assay pre-treatment with TKIs: 24,9 vs. 19,6 m (p = 0.107) and 47,3 vs. 19,9 m (p = 0.76), respectively. To evaluate the association between T790M pretreatment and in the moment of progression we selected 16 pts with T790M mutation analyzed at progression (8 T790M+ and 8 T790M-). T790M at the time of progression was detected in 7 (63,6%) of 11 T790M- diagnosis patients, whilst only 1 (20%) of 5 T790M+ diagnosis patients were positive at the time of progression.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Both methods were highly effective for detection of EGFR T790M mutation. The detection of T790M mutation pretreatment of 1st/2ndgeneration EGFR TKIs by ultrasensitive PCR assay was associated with better PFS and OS.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      Precision Medicine and Biomarkers Unit. IISLAFE.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca.

      682889d0a1d3b50267a69346a750433d Disclosure

      O.J. Juan Vidal: Honoraria, advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme, Roche/Genetech, AstraZeneca, Pfizer, Eli Lilly, AbbVie; Institutional research funding: Bristol-Myers Squibb, AstraZeneca. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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